LGC Pharma Current
LGC Pharma Current
LGC Pharma Current
standard.
High quality reference standards
for the pharmaceutical industry.
2023 | Issue 1.0
Welcome to Mikromol.
We work with you to
provide better, safer
medicines.
For more than 29 years Mikromol Over
has produced high quality
reference standards used in
the pharmaceutical industry for:—
7,000
reference standards
Analytical development
— Method validation for impurities, APIs
— Stability and release testing and excipients, for
more than
What to expect in this catalogue:
An introduction to Mikromol
How to read your Certificate of Analysis
2
3
1,000
API families
Contact details 7
2
How to read your
Certificate of Analysis.
Every product you receive comes with a comprehensive,
multi-page Certificate of Analysis (CoA).
Each CoA provides a full description of the material to which it relates, as well
as a summary of the analyses undertaken during the characterisation process.
CoA Sections
General information | Additional product information | Assay | Purity | Identity |
Stability and homogeneity | Revision table
General information
1
Q uality level
2 Product information
3 Assay value and
uncertainty
– F or ISO 17025 and
ISO 17034 certificates,
Certificate of Analysis ISO 17034 1 determined by an
accredited absolute
Reference Standard method (qNMR and/or
2 Product Name carbon titration)
Tramadol Hydrochloride
– F or ISO 9001 certificates,
Product Code Lot Number
MM0007.00-0250 G1010777 determined in the
CAS No. Appearance majority of the cases
36282-47-0 white solid
Mol. Weight Melting Point (DSC) by 100%-method (no
299.84 181°C
uncertainty given for
Mol. Formula Long-term Storage
C16H25NO2 HCl 2 to 8°C, dark ISO 9001)
4 Intended use: For ISO 17034
products and products
3 Assay1 “as is” Uncertainty2 U manufactured according
99.4% 0.6%
to ISO 17025
Intended Use: Use for identification and quantification. The assay is verified by a second testing method.
Due to the homogeneity studies, the minimum amount of sample to be used is 10mg.
4 5 Date of shipment (DOS)
and validity of the product
Date of shipment: 02 Sep 2019 5 based on DOS
Producer confirms that this reference material (RM) meets the specification detailed on this Certificate for two years from the date of shipment,
provided the substance is stored under the recommended conditions unopened in the original container.
6 Release information
7 Information about
Release by: Date of Release:
6 accreditations and
Dr. S. Schröder Luckenwalde, 21 Aug 2019 Product Release manufacturer
1
Calibration and verification were carried out using standards traceable to SI-units. The value is expressed on an “as is” basis.
2
The uncertainty “U” is the expanded uncertainty of the testing method for the assigned value estimated in accordance with
the Guide to the Expression of Uncertainty in Measurement (GUM). It corresponds to a level of confidence of about 95%.
Coverage factor k =2.
Organisation certified to ISO 9001 | DQS 102448 and GMP (EXCiPACT) RM Producer: Page 1/8
7 Production accredited to ISO 17034 | DAkkS D-RM-14176-01-00 | Test methods LGC GmbH
for characterization are accredited to ISO/IEC 17025 | DAkkS D-PL-14176-01-00 Louis-Pasteur-Str. 30
D-14943 Luckenwalde
Germany
www.lgcstandards.com
D-RM-14176-01-00
3
How to read your Certificate
of Analysis (continued).
This RM is intended for laboratory use only and is not suitable for human or animal consumption.
This RM conforms to the characteristics of a primary standard as described in the ICH guidelines. The values
quoted in this Certificate of Analysis are the producer’s best estimate of the true values within the stated
uncertainties and based on the techniques described in this Certificate of Analysis. The production of this
RM was undertaken in accordance with the requirements of ISO 17034. The identity is verified by data from
international scientific literature.
Before usage of the RM, it should be allowed to warm to room temperature. No drying is required, as assigned
values are already corrected for the content of water and other volatile materials.
10 Further content
Assigned value
Identity
4
How to read your Certificate
of Analysis (continued).
13 Purity
Purity by High Performance Liquid Chromatography (HPLC)
HPLC Conditions:
Purity section
13 Organic purity is usually
assessed by HPLC or GC.
Conditions, chromatogram
and area report are
displayed
Area Percent Report - Sorted by Signal 14 Volatile content: Water
Pk # Retention time Area Area%
content is determined
1 3.330 0.056 0.04
13 by Karl Fischer titration.
2 5.817 0.050 0.04
5
How to read your Certificate
of Analysis (continued).
Identity
The identity is assessed by ISO/IEC 17025 accredited testing methods.
264.19545
Identity section
16
1
H-NMR spectra
17 MS spectra
Rel. Intensity (%)
18 IR spectra
Revision table
20 Record of changes
that have been made
to the CoA
Product warranties for the RM are set out in the terms and conditions of purchase.
6
worldwide
13
8 18 12 14
5
4 6 15
19 9 2
17
10
3
11
1 16
7 India 14 Poland
T +91 9082974025 T +48 22 751 31 40
E india@lgcgroup.com E pl@lgcstandards.com
7
Our reference standards
lgcstandards.com/mikromol
Technical questions?
mikromol@lgcgroup.com
Abacavir Sulfate
NH
N
N O O
OH
2
N H2
Impurity C (EP): [(1S,4R)-4-(2,6-Diamino-9H-purin-9-yl) N
N
cyclopent-2-enyl]methanol H 2N N N
N H2
Impurity C (EP): [(1S,4R)-4-(2,6-Diamino-9H-purin-9-yl) N
N
MM3249.01- cyclopent-2-enyl]methanol H 2N N N
NH
N
MM3249.10- Impurity E (EP): [(1R,3S)-3-[2-Amino-6-(cyclopropylamino)- N
208762-35-0 25mg H2 N N N
0025 9H-purin-9-yl]cyclopentyl]methanol
OH
NH
Impurity F (EP): 6-(Cyclopropylamino)-9-[(1R,4S)-4-[[(1,1- N
N
MM3249.11-
dimethylethyl)oxy]methyl]cyclopent-2-enyl]-9H-purine-2- 1443421-68-8 25mg H 2N N N
0025
amine (Abacavir tert-Butyl Ether) O
[(1S,4R)-4-(2-Amino-6-chloro-9H-purin-9-yl)cyclopent-2-enyl] Cl
N
N
MM3249.02- methanol Hydrochloride H 2N N N HCl
172015-79-1 25mg
0025 Related compound C (USP): [(1S,4R)-4-(2-amino-6-chloro-
OH
9H-purin-9-yl)cyclopent-2-enyl]methanol
NH2
MM3249.04- N N
2,6-Diaminopurine 1904-98-9 100mg
0100 N
H 2N N
H
Cl
MM3249.05- NH2
4,6-Dichloropyrimidine-2,5-diamine 55583-59-0 25mg N
0025
H 2N N Cl
NH
N
N
MM3249.06- H 2N N N
O-Acetylabacavir 178456-36-5 25mg
0025
O
O
Cl
H
N O
MM3249.12- N
4,6-Dichloro-2,5-diformamidopyrimidine 116477-30-6 25mg HN N Cl
0025
O
Cl
H
N O
MM3249.16- O N
N-(4,6-Dichloro-5-formamidopyrimidin-2-yl)acetamide 136470-91-2 25mg
0025 N N Cl
H
Cl
H
N O
O N
MM3249.17- N-[4-Chloro-5-formamido-6-[[(1R,4S)-4-(hydroxymethyl) N N NH
136522-32-2 25mg H
0025 cyclopent-2-en-1-yl]amino]pyrimidin-2-yl]acetamide
OH
NH
MM3249.18-
2-Amino-6-(cyclopropylamino)-9H-purine 120503-69-7 25mg N
N
0025
H 2N N N
H
Cl
H
MM3249.19- N O
N
N-(2-Amino-4,6-dichloropyrimidin-5-yl)formamide 171887-03-9 25mg
0025 H2 N N Cl
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-1
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
N
HN
MM3249.20- N
(-)-Carbovir 120443-30-3 25mg H 2N N
0025
OH
Abemaciclib
F
N N N
F N
MM3932.00- N N
H
Abiraterone
N
H H
HO
Abiraterone Acetate
N
H H
HO
H
MM3504.01 16-Dehydropregnenolone Acetate 979-02-2 100mg O
H H
O
MM3504.01- H
16-Dehydropregnenolone Acetate 979-02-2 25mg O
0025 H H
O
MM3504.02-
Diethyl(3-pyridinyl)borane 89878-14-8 25mg
0025 B
O O
O S F
Androsta-5,16-diene-3 ,17-diol 3-Acetate 17- F
F
H
MM3504.04 115375-60-5 100mg O
Trifluoromethanesulfonate H H
O
O O
O S F
MM3504.04- Androsta-5,16-diene-3 ,17-diol 3-Acetate 17- F
F
H
115375-60-5 25mg O
0025 Trifluoromethanesulfonate H H
O
Acamprosate Calcium
Impurity A (EP): 3-Aminopropane-1-sulfonic Acid
O O
(Homotaurine)
MM3407.01 H 2N S
Related compound A (USP): 3-aminopropane-1-sulfonic
3687-18-1 100mg OH
acid
Impurity A (EP): 3-Aminopropane-1-sulfonic Acid
O O
MM3407.01- (Homotaurine)
H 2N S
Related compound A (USP): 3-aminopropane-1-sulfonic
3687-18-1 25mg OH
0025
acid
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-2
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
Acarbose
HO HO HO
MM0916.00- OH OH
O
OH
O
OH
O
OH
Acarbose 56180-94-0 250mg OH N O O
0250 H
OH OH OH OH
Acebutolol Hydrochloride
O
OH
H
MM0435.00- O N
Acebutolol Hydrochloride 34381-68-5 250mg O
N HCl
0250 H
(Diacetolol Hydrochloride)
MM0435.02 73899-76-0 100mg HCl
N
H
(Diacetolol Hydrochloride)
73899-76-0 25mg HCl
0025 N
H
butanamide O
OH
MM0435.03- butanamide O
OH
N HCl
H
0025 phenyl]butanamide Hydrochloride
O
96480-91-0 25mg
0025 dihydroxypropoxy]phenyl]butanamide N
H
bis[(2-hydroxypropane-1,3-diyl)oxy(3-
OH OH
MM0435.07- O N O
n/a 25mg
acetyl-1,4-phenylene)]]dibutanamide
HN NH
0025 O O
(Acebutolol Biamine)
O
OH
O
O
N
0025 Related compound I (USP): N-3-Acetyl-4-[3-(ethylamino)-2- H
hydroxypropoxy]phenylbutyramide
N HCl
0025 propoxy]phenyl]propanamide Hydrochloride H
N HCl
0025 propoxy]phenyl]butanamide Hydrochloride H
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-3
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
O
MM0877.16-
2-Etoxyacetophenone 2142-67-8 100mg
0100
O
Acecarbromal
O O O
Br
MM1724.00 Acecarbromal 77-66-7 50mg N
H
N
H
Aceclofenac
O
O
OH
O
MM0181.00 Aceclofenac 89796-99-6 250mg NH
Cl Cl
OH
O
MM0006.20- Impurity A (EP): [2-[(2,6-Dichlorophenyl)- NH
15307-86-5 250mg
0250 amino]phenyl]acetic Acid (Diclofenac) Cl Cl
O
O
Impurity D (EP): Methyl [[[2-[(2,6-Dichloro- O
O
MM0181.01 phenyl)amino]phenyl]acetyl]oxy]- 139272-66-5 100mg NH
Cl Cl
acetate (Methyl Ester of Aceclofenac)
O
O
Impurity D (EP): Methyl [[[2-[(2,6-Dichloro- O
MM0181.01- O
phenyl)amino]phenyl]acetyl]oxy]- 139272-66-5 25mg NH
Cl Cl
0025 acetate (Methyl Ester of Aceclofenac)
O
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-4
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
O O
MM0181.04 amino]phenyl]acetyl]oxy]acetyl]oxy]acetic 1215709-75-3 100mg Cl
NH
Cl
O O
amino]phenyl]acetyl]oxy]acetyl]oxy]acetic 1215709-75-3 25mg Cl
NH
Cl
0025 Acid (Acetic Aceclofenac)
O O
O
N
Impurity I (EP): 1-(2,6-Dichlorophenyl)-1,3-
MM0006.01
dihydro-2H-indol-2-one
15362-40-0 100mg Cl Cl
O
N
MM0006.01- Impurity I (EP): 1-(2,6-Dichlorophenyl)-1,3-
15362-40-0 25mg Cl Cl
0025 dihydro-2H-indol-2-one
Isopropyl [2-[(2,6-Dichlorophenyl)- NH
O
O
O
O
O
NH
MM0181.11 Aceclofenac Isopropyl Ester n/a 100mg Cl Cl
O
O
O
MM0181.11- NH
O
Aceclofenac Isopropyl Ester n/a 25mg Cl Cl
0025
O OH
O
O
O
O
MM0181.12- Cl
NH
Cl
O
O OH
O
Aceclofenac 1,3-Butylene Glycol Esters (Mixture of Isomers) n/a 25mg Cl
NH
Cl
0025
O
O
O
O OH
NH O
MM0181.14- Cl Cl O
O
OH
0025 Cl Cl
Acefylline
O
O
OH
N
MM1727.00 Acefylline 652-37-9 250mg N
O N N
Acemetacin
O
O O
OH
N
O
Cl
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-5
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
Cl
O
MM0063.03- OH
Impurity A (EP): 4-Chlorobenzoic Acid 74-11-3 25mg
0025
Cl
O
OH
N
Impurity B (EP): [1-(4-Chlorobenzoyl)-5-methoxy-2- O
MM0584.00 53-86-1 500mg Cl
methylindol-3-yl]acetic Acid (Indometacin)
O
O O
O
MM1728.01- N
O
Acemetacin Methyl Ester 681838-84-6 25mg
0025 Cl
O
O O
O
MM1728.02- N
O
Acemetacin Ethyl Ester 76812-43-6 25mg
0025 Cl
O
O
O O
O
MM1728.03- N
O
Acemetacin Isopropyl Ester n/a 25mg
0025 Cl
O
O OH
O O
O
N
O
O
MM1728.05- Cl
O
Cl
O O
O
MM1728.06- N
O OH
Acemetacin 2,3-Butylene Glycol Ester n/a 25mg
0025 O
Cl
O O
O
N
O OH
O
MM1728.07- Cl
O O OH
0025 O
N
O
O
Cl
O O
O OH
N
O OH
MM1728.08- Cl
O O
OH
O
Cl
O
O
O
MM1728.09- (2-Methoxy-2-oxoethyl) 2-(5-Methoxy-2-methyl-1H-indol-3-yl) HN
O
n/a 25mg
0025 acetate
O
MM1728.10- HN
O
Methyl 2-(5-Methoxy-2-methyl-1H-indol-3-yl)acetate 7588-36-5 25mg
0025
O
O
O
O
MM1728.11- (2-Ethoxy-2-oxoethyl) 2-(5-Methoxy-2-methyl-1H-indol-3-yl) HN
O
n/a 25mg
0025 acetate
O
O
MM1728.12- HN
O
Ethyl 2-(5-Methoxy-2-methyl-1H-indol-3-yl)acetate 17536-38-8 25mg
0025
O
O
O
O
MM1728.13- (2-Isopropoxy-2-oxoethyl) 2-(5-Methoxy-2-methyl-1H-indol-3- HN
O
n/a 25mg
0025 yl)acetate
O
Acenocoumarol
O
+
O O N
O
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-6
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
Acepromazine Maleate
O
N N
OH
MM0927.00 Acepromazine Maleate 3598-37-6 250mg S
OH
O
O
Acesulfame Potassium
O NH2
MM1093.01 Impurity A (EP): 3-Oxobutanamide (Acetylacetamide) 5977-14-0 100mg
O
Acetaminosalol
H
N
O
OH
Acetazolamide
O O
H
S S N
MM0648.00 Acetazolamide 59-66-5 500mg H2 N
N N O
H
Impurity A (EP): N-(5-Chloro-1,3,4-thiadiazol-2- Cl S N
MM0648.04 60320-32-3 50mg
yl)acetamide N N O
H
S N
MM0648.01 Impurity B (EP): N-(1,3,4-Thiadiazol-2-yl)acetamide 5393-55-5 50mg
N N O
Acetildenafil
O
N O HN N
Acetomenaphthone
O
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-7
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
Acetophenazine Maleate
O
N N
O
OH
OH
O 2
Acetylcysteine
O
HS OH
MM0024.00 N-Acetyl-L-cysteine 616-91-1 500mg HN
N H2 O
NH O
NH O
MM0024.04-
Impurity C (EP): N,N'-Diacetyl-L-cystine 5545-17-5 25mg HO S
S OH
0025 O HN
O O
S OH
MM0024.01 Impurity D (EP): N,S-Diacetyl-L-cysteine 18725-37-6 100mg HN
O O
MM0024.01- S OH
Impurity D (EP): N,S-Diacetyl-L-cysteine 18725-37-6 25mg HN
0025
O
O
Sodium 2-Methyl-4,5-dihydro-1,3-thiazol- N
O
Na
+
4-carboxylate
MM0024.05 15058-19-2 100mg
S
O
MM0024.05- Sodium 2-Methyl-4,5-dihydro-1,3-thiazol- N
O
Na
+
4-carboxylate
15058-19-2 25mg
0025 S
HS OH
MM0024.06 N-Propionyl-L-cysteine 2885-79-2 100mg HN
MM0024.06- HS OH
N-Propionyl-L-cysteine 2885-79-2 25mg HN
0025
O
HS O
MM0024.08 N-Acetyl-L-cysteine Methyl Ester 7652-46-2 100mg HN
MM0024.08- HS O
N-Acetyl-L-cysteine Methyl Ester 7652-46-2 25mg HN
0025
O
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-8
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
HS O
MM0024.09 N-Acetyl-L-cysteine Ethyl Ester 59587-09-6 100mg HN
MM0024.09- HS O
N-Acetyl-L-cysteine Ethyl Ester 59587-09-6 25mg HN
0025
O
MM0024.10- HS O
N-Acetyl-L-cysteine Isopropyl Ester 73255-51-3 25mg HN
0025
O
NH O
MM0024.11- O S
N,N'-Diacetyl-L-cystine Dimethyl Ester 32381-28-5 25mg S O
O HN
0025
O
OH
MM0133.00-
Acetylsalicylic Acid 50-78-2 250mg
0250 O
O
MM0045.01-
Impurity A (EP): 4-Hydroxybenzoic Acid 99-96-7 250mg OH
0250
HO
O O
O O
MM0045.02- Impurity B (EP): 4-Hydroxybenzene-1,3- HO OH
636-46-4 25mg
0025 dicarboxylic Acid (4-Hydroxyisophthalic Acid) OH
O
MM0045.00- OH
Impurity C (EP): Salicylic Acid 69-72-7 250mg
0250
OH
OH O
Impurity D (EP): 2-[[2-(Acetyloxy)benzoyl]oxy]- O O
MM0133.01 530-75-6 100mg
benzoic Acid (Acetylsalicylsalicylic Acid)
O
OH O
MM0133.01- Impurity D (EP): 2-[[2-(Acetyloxy)benzoyl]oxy]- O O
530-75-6 25mg
0025 benzoic Acid (Acetylsalicylsalicylic Acid)
O
OH
MM0133.03- Impurity E (EP): 2-[(2-Hydroxybenzoyl)oxy]- O OH
552-94-3 250mg
0250 benzoic Acid (Salicylsalicylic Acid)
O
O O O
Impurity F (EP): 2-(Acetyloxy)benzoic Anhydride O
MM0133.02 1466-82-6 100mg
(Acetylsalicylic Anhydride) O
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-9
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
O O O
MM0133.02- Impurity F (EP): 2-(Acetyloxy)benzoic Anhydride O
1466-82-6 25mg
0025 (Acetylsalicylic Anhydride) O
OH
O
OH
OH
O
MM0133.04-
2-(2,4-Dihydroxybenzoyl)benzoic Acid 2513-33-9 25mg OH
0025
OH
O O
MM0133.08- HO OH
4-Acetoxyisophthalic Acid 5985-26-2 25mg O
0025
O
OH
O
MM0133.09-
Acetylsalicylsalicylsalicylic Acid 85531-16-4 25mg O O
0025 O O
O
MM0133.11-
4-Acetoxybenzoic Acid 2345-34-8 25mg O OH
0025 O
O
MM0133.12 Methyl Acetylsalicylate 580-02-9 100mg
O
O
MM0133.12-
Methyl Acetylsalicylate 580-02-9 25mg
0025 O
O
MM0133.13 Ethyl Acetylsalicylate 529-68-0 100mg
O
O
MM0133.14 Isopropyl Acetylsalicylate 2224-88-6 50mg
O
O OH
O
MM0133.19- O
Hexanedioic Acid Mono-(2-carboxyphenyl) Ester 863985-44-8 25mg OH
0025 O
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-10
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
HO O
O
MM0133.20- O
O O
N-Acetyltryptophan
H
N
NH2
H
N
NH2
MM1267.01-
Impurity A (EP): Tryptophan 54-12-6 25mg OH
0025 O
H
N
Impurity D (EP): (S)-2-Amino-3-(5-hydroxy-
NH2
MM0172.03 1H-indol-3-yl)propanoic Acid (5-Hydroxy- 4350-09-8 100mg HO
tryptophan) O
OH
N-Acetyltyrosine
O
HO
HN
MM3571.00 N-Acetyltyrosine (N-Acetyl-L-Tyrosine) 537-55-3 250mg OH
Aciclovir (Acyclovir)
O
N
HN
MM0061.00 Aciclovir 59277-89-3 500mg N
OH
H2 N N
O
N
HN
MM0061.01 Acetate 102728-64-3 100mg H2 N N N
O
O
9H-purin-9-yl)methoxy]ethyl acetate
Impurity A (EP): 2-[(2-Amino-6-oxo-1,6-
MM0061.01- dihydro-9H-purin-9-yl)methoxy]ethyl O
N
HN
Acetate 102728-64-3 25mg H2 N N N
O
O
0025 Related compound A (USP): 2-[(2-amino-6-oxo-1,6-dihydro- O
9H-purin-9-yl)methoxy]ethyl acetate
O
H
Impurity B (EP): 2-Amino-1,7-dihydro-6H- HN
N
MM0061.02 73-40-5 100mg
purin-6-one (Guanine)
H 2N N N
H 2N N N
6-one
H 2N N N
0025 6-one
O
2-[(2-Amino-6-oxo-1,6-dihydro-9H-purin- HN
N
O
MM0061.04
9-yl)methoxy]ethyl Benzoate
59277-91-7 100mg H2 N N N O
O
O
MM0061.04- 2-[(2-Amino-6-oxo-1,6-dihydro-9H-purin- HN
N
O
9-yl)methoxy]ethyl Benzoate
59277-91-7 25mg H2 N N N O
0025 O
N
O HN
MM0061.06 yl]acetamide 110104-37-5 100mg N N N
OH
methyl]-6-oxo-6,9-dihydro-1H-purin-2-yl]acetamide
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-11
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
N
O HN
yl]acetamide 110104-37-5 25mg N N N
OH
methyl]-6-oxo-6,9-dihydro-1H-purin-2-yl]acetamide
Impurity G (EP): 2-[[(2-(Acetylamino)-6-
oxo-1,6-dihydro-9H-purin-9-yl]- O
N O
O HN
MM0061.07 methoxy]ethyl Acetate 75128-73-3 100mg N N N
O
dihydro-9H-purin-9-yl]methoxyethyl acetate
Impurity G (EP): 2-[[(2-(Acetylamino)-6-
MM0061.07- oxo-1,6-dihydro-9H-purin-9-yl]- O
N O
O HN
methoxy]ethyl Acetate 75128-73-3 25mg N N N
O
dihydro-9H-purin-9-yl]methoxyethyl acetate
O
MM0061.08- 2-[[2-(Acetylamino)-6-oxo-1,6-dihydro- O HN
N
O
133186-23-9 25mg
0025 9H-purin-9-yl]methoxy]ethyl Benzoate N
H
N N
O
O
O O
MM0061.21- Impurity K (EP): 2,2'-[Methylenediimino]bis[9-[(2- HO
N
NH HN
N
OH
1797131-64-6 25mg O
N N N
H
N
H
N N
O
0025 hydroxyethoxy)methyl]1,9-dihydro-6H-purin-6-one]
Cl
MM0061.10- N
2,6-Dichloropurine N
5451-40-1 25mg
0025
Cl N N
H
N
O HN
MM0061.12 N2-Acetylguanine 19962-37-9 100mg
N N N
H H
N
MM0061.12- O HN
N2-Acetylguanine 19962-37-9 25mg
0025 N N N
H H
Acitretin
O
O
MM3076.00 (Etretinate) 54350-48-0 100mg O
Adapalene
O
MM0681.00-
Adapalene 106685-40-9 250mg
0250 OH
dicarboxylic Acid
Related compound E (USP): 2,2'-binaphthyl-6,6'-
MM0681.03 932033-58-4 50mg
OH
dicarboxylic acid O
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-12
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
O
Impurity C (EP): 1-(2-Methoxyphenyl)tricyclo-
[3.3.1.13,7]decane
Related compound C (USP): 2-(adamant-1-yl)
MM0681.01 43109-77-9 50mg
methoxybenzene
diyl]bis(tricyclo[3.3.1.13,7]decane)
Related compound D (USP): 4,4'-dimethoxy-3,3'-di
MM0681.02 932033-57-3 50mg
O
(adamant-1-yl)biphenyl
Br
Methyl 6-Bromo-2-naphthoate
MM0681.05 33626-98-1 100mg O
Related compound A (USP): Methyl 6-bromo-2-naphthoate
O
Br
Methyl 6-[3-(1-Adamantyl)-4-methoxyphenyl]-2-naphthoate O
O
methoxyphenyl]-2-naphthoate
Methyl 6-[3-(1-Adamantyl)-4-methoxyphenyl]-2-naphthoate O
O
methoxyphenyl]-2-naphthoate
Adefovir Dipivoxil
N H2
O
N
N O
O
N P O
N O
O
MM3505.00 Adefovir Dipivoxil 142340-99-6 250mg
O
Adenine
NH2
H
N
MM1495.00 Adenine 73-24-5 250mg N
N N
Adenosine
N H2
N
N
MM0784.00- HO N
Adenosine 58-61-7 250mg N
O
0250
O HO H
NH2
NH2
MM0784.01- Impurity A (EP) as Sulphate: 7H-Purin-6-amine N
N
HO
O
S OH
321-30-2 25mg
0025 Sulphate (Adenine Sulphate) N N
H 2
O
HN
O HO H
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-13
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
HN
O HO H
O
N
HN
O HO H
O
N
HN
H2 N N N
Impurity H (EP): 2-Amino-9- -D-ribofuranosyl-
MM0784.04 118-00-3 100mg H O
1,9-dihydro-6H-purin-6-one (Guanosine) O
OH OH
O
N
HN
H2 N N N
MM0784.04- Impurity H (EP): 2-Amino-9- -D-ribofuranosyl-
118-00-3 25mg H O
0025 1,9-dihydro-6H-purin-6-one (Guanosine) O
OH OH
N
N
N N
HO
O O
P
O O
N
N
+
N Na
N
2
H 2O
3
HO
O O O OH
P P P
O O O O O OH
Adiphenine Hydrochloride
O
N
Adiphenine Hydrochloride
O HCl
MM1172.00 50-42-0 250mg
Adipic Acid
O
HO
MM1008.02 Adipic Acid 124-04-9 250mg OH
O
Adrenaline Tartrate
HO N HO
OH
MM0614.00 51-42-3 500mg HO O OH
OH
H
HO N
MM0614.02 L-Adrenaline 51-43-4 500mg
HO
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-14
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
OH
H
MM0614.12- HO N HCl
DL-Adrenaline Hydrochloride 329-63-5 25mg
0025 HO
OH
H
HO N
MM0614.15 DL-Adrenaline 329-65-7 100mg
HO
OH
H
MM0614.15- HO N
DL-Adrenaline 329-65-7 25mg
0025 HO
OH
(1R)-1-(3,4-Dihydroxyphenyl)-2- O S O
H
MM0614.01 methylaminoethanesulphonic Acid 78995-75-2 100mg HO N
(Adrenaline -Sulphonate) HO
OH
(1R)-1-(3,4-Dihydroxyphenyl)-2- O S O
H
MM0614.01-
methylaminoethanesulphonic Acid 78995-75-2 25mg HO N
0025 (Adrenaline -Sulphonate) HO
OH
OH
OH
OH
MM0262.06-
4-Hydroxy-3-methoxymandelic Acid 55-10-7 25mg O
0025 HO
O
Afatinib Dimaleate
O N
O O
N
HN
F O
OH
OH
2
Cl
Agomelatine
H
N
N
MM3583.01 7-Methoxy-1-naphthaleneacetonitrile 138113-08-3 100mg
O
N
MM3583.01-
7-Methoxy-1-naphthaleneacetonitrile 138113-08-3 25mg
0025
O
Ajmaline
HO
H
H
N
HH
H
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-15
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
Alanine
NH2
OH
MM0566.00 Alanine 56-41-7 500mg
O
O NH2
Impurity A (EP): (2S)-2-Aminobutanedioic Acid (Aspartic OH
MM0567.00 56-84-8 500mg HO
Acid) O
NH2
Impurity B (EP): (2S)-2-Aminopentanedioic Acid (Glutamic HO OH
MM1333.00 56-86-0 250mg
Acid) O O
Albendazole
O
H
N O
MM0382.00 Albendazole 54965-21-8 500mg N
N
H
S
H
Impurity A (EP): 5-(Propylsulphanyl)-1H- N
NH2
MM0382.01 80983-36-4 100mg
benzimidazol-2-amine S N
H
MM0382.01- Impurity A (EP): 5-(Propylsulphanyl)-1H- N
NH2
80983-36-4 25mg
0025 benzimidazol-2-amine S N
O
H
Impurity B (EP): Methyl [5-Propylsulphinyl)- N
N
O
O
H
MM0382.02- Impurity B (EP): Methyl [5-Propylsulphinyl)- N
N
O
54029-12-8 25mg H
0025 1H-benzimidazol-2-yl]carbamate S
O
N
O
H
Impurity C (EP): Methyl [5-Propylsulphonyl)- N
N
O
O
H
MM0382.03- Impurity C (EP): Methyl [5-Propylsulphonyl)- N
N
O
75184-71-3 25mg H
0025 1H-benzimidazol-2-yl]carbamate O
S
O
N
H
Impurity D (EP): 5-(Propylsulphonyl)-1H-benzimidazol-2- N
N H2
MM0382.04 80983-34-2 100mg
amine O
S
O
N
H
MM0382.04- Impurity D (EP): 5-(Propylsulphonyl)-1H-benzimidazol-2- N
N H2
80983-34-2 25mg
0025 amine O
S
O
N
O
H
Impurity E (EP): Methyl (1H-Benzimidazol-2- N O
MM2500.00 10605-21-7 100mg N
yl)carbamate (Carbendazim) N
H
O
MM0382.09- N O
N
N3-Methylalbendazole 1149360-33-7 25mg N H
S
0025
Alclofenac
Cl O
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-16
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
Cl O
MM1783.01-
Alclofenac Methyl Ester 23918-07-2 25mg O
O
0025
Cl O
O
MM1783.02 Alclofenac Ethyl Ester 20788-45-8 100mg O
Cl O
O
MM1783.03 Alclofenac Isopropyl Ester 69801-29-2 100mg O
Alfacalcidol
HO OH
0250 O
Alfuzosin Hydrochloride
H
MM1004.00- O N N N
O
0250 N H2
O N Cl
MM0085.04- Impurity B (EP): 2-Chloro-6,7-dimethoxyquinazolin- N
23680-84-4 25mg O
0025 4-amine NH2
Algestone Acetophenide
O
H
O
H
MM0476.03 16-Dehydroprogesterone 1096-38-4 100mg
H H
O
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-17
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
MM0476.03- H
16-Dehydroprogesterone 1096-38-4 25mg
0025 H H
O
Allantoin
O O
H2 N
NH
MM1627.00 Allantoin 97-59-6 250mg N
H N O
H
Allobarbital
H
O N O
Allopurinol
O
MM0034.00- NH
Allopurinol 315-30-0 250mg N
0250
N N
H
carboxamidopyrazole
O
Impurity C (EP): 5-(4H-1,2,4-Triazol-4-yl)-
NH2
MM0034.04- 1H-pyrazole-4-carboxamide N
Related compound C (USP): 5-(4H-1,2,4-triazol-4-yl)-1H-
1346604-13-4 25mg
0025 N N
H
pyrazole-4-carboxamide N
N
MM0034.05- 4-carboxylate O
N
Related compound D (USP): ethyl 5-amino-1H-pyrazole-4-
6994-25-8 25mg
0025 N NH2
carboxylate H
O
Impurity E (EP): Ethyl 5-(Formylamino)-1H-
MM0034.06- pyrazole-4-carboxylate O
N
Related compound E (USP): ethyl 5-(formylamino)-1H-
31055-19-3 25mg
0025 N N O
pyrazole-4-carboxylate H H
NH
MM0034.07 Oxypurinol 2465-59-0 100mg N
N N O
H H
MM0034.07- NH
Oxypurinol 2465-59-0 25mg N
0025 N N O
H H
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-18
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
Ethyl (E/Z)-3-(2-Carbethoxy-2-cyanoethenyl)amino-1H- O
O
MM0034.10- pyrazole-4-carboxylate N N
321571-07-7 25mg N N
0025 Related compound F (USP): ethyl-(E/Z)-3-(2-carbethoxy-2- H H
O O
cyanoethenyl)amino-1H-pyrazole-4-carboxylate
O
5-(Formylamino)-1H-pyrazole-4-carboxamide
MM0034.03- NH2
Related compound B (USP): 5-(formylamino)-1H-pyrazole-4- 22407-20-1 25mg N
0025 N
carboxamide N O
H H
Almotriptan Malate
O
N
MM3978.07- S O
4-(Pyrrolidin-1-ylsulfonylmethyl)aniline 334981-10-1 25mg
0025
N H2
Alogliptin
H2 N
N
N
MM3928.00-
Alogliptin 850649-61-5 250mg N
0250
O N O
Alosetron Hydrochloride
H
N N
N
MM3508.01-
4-Methylimidazole 822-36-6 25mg
0025 N
H
Alprazolam
N
N
N
N H2
O
MM0028.03- Impurity E (EP): (2-Amino-5-chlorophenyl)- Cl
719-59-5 25mg
0025 phenylmethanone
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-19
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
N N
N
HO
N
N
2-(2-Acetylhydrazino)-7-chloro-5-phenyl-3H-1,4- H
N N
N H
MM0136.07- benzodiazepine
28910-89-6 25mg Cl N
0025 Related compound A (USP): 2-(2-acetylhydrazino)-7-chloro-
5-phenyl-3H-1,4-benzodiazepine
Alprostadil
O
O
OH
MM1219.10-
Impurity K (EP): Triphenylphosphine Oxide 791-28-6 25mg P O
0025
Alverine Citrate
O
OH
OH
propan-1-amine Hydrochloride
Hydrochloride
N
0025 Hydrochloride
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-20
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
Alvimopan Dihydrate
O
HO OH
N N
Amantadine Hydrochloride
NH 2
HCl
MM0564.00 Amantadine Hydrochloride 665-66-7 500mg
MM0564.03-
Adamantane 281-23-2 25mg
0025
Ambrisentan
O OH
N
MM3756.00-
Ambrisentan 177036-94-1 250mg O N
0250 O
O OH
OH
MM3756.01 (S)-2-Hydroxy-3-methoxy-3,3-diphenylpropionic Acid 178306-52-0 100mg O
O OH
MM3756.01- OH
(S)-2-Hydroxy-3-methoxy-3,3-diphenylpropionic Acid 178306-52-0 25mg O
0025
Ambroxol Hydrochloride
OH
MM0005.00- Br
0250 N H2
Br
Br
OH
Impurity A (EP): (2-Amino-3,5-
MM0005.01 50739-76-9 100mg
dibromophenyl)methanol NH2
Br
Br
OH
MM0005.01- Impurity A (EP): (2-Amino-3,5-
50739-76-9 25mg
0025 dibromophenyl)methanol NH2
Br
OH
Impurity B (EP) as Hydrochloride: trans-4-(6,8- Br
N
MM0005.04 Dibromo-1,4-dihydroquinazolin-3(2H)-yl)- 15942-08-2 100mg
N HCl
cyclohexanol Hydrochloride Br
H
OH
OH
OH
OH
Impurity D (EP) as Hydrochloride: cis-4-[(2- Br
N
MM0005.05 Amino-3,5-dibromobenzyl)amino]- 1384955-66-1 100mg H HCl
N H2
cyclohexanol Hydrochloride Br
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-21
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
OH
Br
O
Impurity E (EP): 2-Amino-3,5-
MM0005.02 50910-55-9 100mg
dibromobenzaldehyde NH2
Br
Br
O
MM0005.02- Impurity E (EP): 2-Amino-3,5-
50910-55-9 25mg
0025 dibromobenzaldehyde NH2
Br
OH
OH
OH
MM0005.07-
cis-4-Aminocyclohexanol Hydrochloride 56239-26-0 25mg H2 N
HCl
0025
O
Br
OH
MM0005.08 2-Amino-3,5-dibromobenzoic Acid 609-85-8 100mg
NH2
Br
O
Br
MM0005.08- OH
2-Amino-3,5-dibromobenzoic Acid 609-85-8 25mg
0025 NH2
Br
OH
O
OH
O
MM0005.10-
trans-2-Amino-N-(4-hydroxycyclohexyl)benzamide 15942-11-7 25mg N
H
0025 NH2
OH
trans-4-(6,8-Dibromoquinazolin-3(4H)-yl)cyclohexanol Br
N HCl
MM0005.11 2356152-56-0 100mg N
Hydrochloride Br
OH
MM0005.11- trans-4-(6,8-Dibromoquinazolin-3(4H)-yl)cyclohexanol Br
N HCl
2356152-56-0 25mg N
0025 Hydrochloride Br
Ambutonium Bromide
O
N H2
MM1780.00 Ambutonium Bromide 115-51-5 100mg N
+
Br
Amcinonide
O
O
O
F H
O
O N H2
MM3533.01- O
Amfenac Methyl Ester 61941-58-0 25mg O
0025
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-22
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
O N H2
O
MM3533.02 Amfenac Ethyl Ester 61941-57-9 100mg O
O N H2
MM3533.02- O
Amfenac Ethyl Ester 61941-57-9 25mg O
0025
O N H2
MM3533.03- O
Amfenac Isopropyl Ester n/a 25mg O
0025
O
H
O N
MM3533.08-
7-Benzoylindolin-2-one (Amfenac Lactam) 51135-38-7 25mg
0025
NH2
HCl
MM0741.06 Amfetamine Hydrochloride 2706-50-5 CS 100mg
OH
Impurity A (EP): (2RS)-1-Phenylpropan-2-ol (1-Phenyl-2-
MM0741.03 698-87-3 100mg
propanol)
O
MM0741.04 Impurity B (EP): 1-Phenylpropan-2-one (Phenylacetone) 103-79-7 100mg
MM0528.05- O
Impurity D (EP): Benzaldehyde 100-52-7 500mg
0500
Amifampridin
NH2
Amikacin
O
NH2
MM1279.01 Impurity I (EP): (2S)-4-Amino-2-hydroxybutanoic Acid 40371-51-5 100mg HO
OH
O
MM1279.01- NH2
Impurity I (EP): (2S)-4-Amino-2-hydroxybutanoic Acid 40371-51-5 25mg HO
0025 OH
Amikacin Sulfate
HO
HO
O O
N H2
H 2N O HN
MM1279.00- O
O
HO
O NH2
OH
HO S
O
OH
H 2N
0250 HO OH
OH
O
NH2
MM1279.01 Impurity I (EP): (2S)-4-Amino-2-hydroxybutanoic Acid 40371-51-5 100mg HO
OH
O
MM1279.01- NH2
Impurity I (EP): (2S)-4-Amino-2-hydroxybutanoic Acid 40371-51-5 25mg HO
0025 OH
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-23
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
chloropyrazine-2-carboxylate Cl N
O
Related compound A (USP): Methyl 3,5-diamino-6-
MM0560.01 1458-01-1 100mg
H2 N N N H2
chloropyrazine-2-carboxylate
Impurity A (EP): Methyl 3,5-Diamino-6- O
MM0560.01- chloropyrazine-2-carboxylate Cl N
O
Related compound A (USP): Methyl 3,5-diamino-6-
1458-01-1 25mg
0025 H2 N N N H2
chloropyrazine-2-carboxylate
O
O
MM0560.02- Impurity B (EP): 3,5-Diamino-6-chloropyrazine-2-carboxylic Cl N
OH
4878-36-8 25mg
0025 Acid
H 2N N NH2
O
MM0560.05- N
Methyl 3-Aminopyrazine-2-carboxylate 16298-03-6 25mg O
0025
N NH2
MM0560.06- N
3-Aminopyrazine-2-carboxylic Acid 5424-01-1 25mg OH
0025
N NH2
O
MM0560.08- Cl N
Methyl 3-Amino-5,6-dichloropyrazine-2-carboxylate 1458-18-0 25mg O
0025
Cl N N H2
H 2N
MM1255.01- OH
Impurity A (EP): 4-Nitrobenzoic Acid 62-23-7 25mg O +
0025 N
O
O
MM0094.00- O
Impurity B (EP): Ethyl 4-Aminobenzoate (Benzocaine) 94-09-7 250mg
0250 H2 N
H2 N
HCl
MM0093.17 Impurity C (EP) as Hydrochloride: Aniline Hydrochloride 142-04-1 100mg
MM1255.06-
4-Nitrobenzaldehyde 555-16-8 25mg O
0025 +
N
O
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-24
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
O
MM1255.07- O
Methyl 4-Aminobenzoate 619-45-4 25mg
0025 H2 N
O
MM1255.08 Isopropyl 4-Aminobenzoate 18144-43-9 100mg
H2 N
O
MM1255.08- O
Isopropyl 4-Aminobenzoate 18144-43-9 25mg
0025 H2 N
Aminocaproic Acid
O
MM0896.00 Aminocaproic Acid 60-32-2 500mg H2 N
OH
Aminoglutethimide
H
O N O
Aminophenazone
O
N N
N
MM1049.01 Dioxypyramidon 519-65-3 100mg O O
O
N N
MM1049.01- N
Dioxypyramidon 519-65-3 25mg O O
0025
Aminotadalafil
O
H
N H2
N
N
N
MM1271.00 Aminotadalafil 385769-84-6 100mg H
O
O
O
Amiodarone Hydrochloride
O
I
O
N
HCl
HO O
O
N
phenyl]methanone Oxalate
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-25
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
HO O
O
N
0025 phenyl]methanone Oxalate
Impurity B (EP) as Hydrochloride: (2-Butylbenzo-
furan-3-yl)[4-[2-(ethylamino)ethoxy]-3,5-di- O
I
I
O
H
N
HCl
(Desethylamiodarone Hydrochloride)
Related compound B (USP)
Impurity B (EP) as Hydrochloride: (2-Butylbenzo-
MM0697.03- furan-3-yl)[4-[2-(ethylamino)ethoxy]-3,5-di- O
I
I
O
H
N
HCl
furan-3-yl)[4-[2-(diethylamino)ethoxy]-3-iodo- O
I
phenyl]methanone Hydrochloride
MM0697.04 n/a 100mg O
MM0697.04- furan-3-yl)[4-[2-(diethylamino)ethoxy]-3-iodo- O
I
phenyl]methanone Hydrochloride
n/a 25mg O
0025
Related compound C (USP)
Impurity D (EP): (2-Butylbenzofuran-3-yl)(4- O
I
hydroxy-3,5-diiodophenyl)methanone O
MM0697.05
Related compound D (USP): (2-butylbenzofuran-3-yl)(4-
1951-26-4 100mg OH
I
hydroxy-3,5-diiodophenyl)methanone
Impurity D (EP): (2-Butylbenzofuran-3-yl)(4- O
I
MM0697.05- hydroxy-3,5-diiodophenyl)methanone O
hydroxyphenyl)methanone O
hydroxyphenyl)methanone
Impurity E (EP): (2-Butylbenzofuran-3-yl)(4- O
MM0697.06- hydroxyphenyl)methanone O
O
N
+O
MM0697.15- O
(2-Butylbenzofuran-3-yl)(4-methoxyphenyl)methanone 83790-87-8 100mg O
0100
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-26
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
Amisulpride
O O O
S
N
MM0793.00 Amisulpride 71675-85-9 250mg H 2N O
H
N
N
MM0793.02 pyrrolidin-2-yl]methyl]-5-(ethylsulphonyl)- 148516-54-5 50mg H 2N OH
H
N
2-hydroxybenzamide
O
(methylsulphonyl)benzamide
O O O
O O O
MM0793.05- Impurity E (EP): 4-Amino-5-(ethylsulphonyl)- S
OH
71675-87-1 25mg
0025 2-methoxybenzoic Acid H 2N O
Amitraz
NH2
Impurity A (BP): 2,4-Dimethylaniline
MM1018.01 95-68-1 100mg
(2,4-Xylidine)
Amitriptyline Hydrochloride
HCl
MM0062.00- N
Amitriptyline Hydrochloride 549-18-8 250mg
0250
O
Impurity A (EP): 10,11-Dihydro-5H-dibenzo-
MM0062.01 [a,d][7]annulen-5-one (Dibenzosuberone) 1210-35-1 100mg
Related compound A (USP): dibenzosuberone
MM0062.02- Dibenzo[a,d][7]annulen-5-ylidene)-N,N- N
6202-23-9 250mg
0250 dimethylpropan-1-amine Hydrochloride
(Cyclobenzaprine Hydrochloride)
Dihydro-5H-dibenzo[a,d][7]annulen-5- N
H
MM0079.00 894-71-3 500mg
ylidene)-N-methylpropan-1-amine
Hydrochloride (Nortriptyline Hydrochloride)
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-27
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
HO
Impurity G (EP): 10,11-Dihydro-5H-dibenzo[a,d][7]annulen-5-
MM0062.14 1210-34-0 100mg
ol (Dibenzosuberol)
HO
MM0062.14- Impurity G (EP): 10,11-Dihydro-5H-dibenzo[a,d][7]annulen-5-
1210-34-0 25mg
0025 ol (Dibenzosuberol)
+
N HCl
MM0062.12 Amitriptyline N-Oxide Hydrochloride 4290-60-2 10mg O
10,11-Dihydro-5H-dibenzo[a,d]cycloheptene
(Dibenzosuberane)
MM0062.13 833-48-7 100mg
MM0062.13- 10,11-Dihydro-5H-dibenzo[a,d]cycloheptene
(Dibenzosuberane)
833-48-7 25mg
0025
O
(10,11-Dihydro-5H-dibenzo[a,d]cyclohepten-5-ylidene)acetic
MM0062.15 3707-33-3 100mg OH
Acid
O
MM0062.15- (10,11-Dihydro-5H-dibenzo[a,d]cyclohepten-5-ylidene)acetic
3707-33-3 25mg OH
0025 Acid
Amlodipine Besilate
H
N NH2
O
O O O
MM0383.00- OH
Amlodipine Besilate 111470-99-6 250mg O O
Cl
O S
0250
H
N NH2
O
O O
N N
6-methyl-1,4-dihydropyridine-3,5- O
O
O O
MM0383.01 88150-62-3 100mg
dicarboxylate O O
Cl
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-28
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
N N
MM0383.01- 6-methyl-1,4-dihydropyridine-3,5- O
O
O O
dicarboxylate
88150-62-3 25mg O O
0025 Cl
ethoxy]methyl]-1,4-dihydropyridine- O O
N
H
O O
3,5-dicarboxylate
MM0383.02 721958-72-1 100mg Cl
3,5-dicarboxylate
721958-72-1 25mg Cl
0025
Related compound B (USP): 3-Ethyl 5-methyl 4-(2-
chlorophenyl)-6-methyl-2-(2-[2-(methylcarbamoyl)benzamido]
ethoxymethyl)-1,4-dihydropyridine-3,5-dicarboxylate
H
3,5-dicarboxylate Dihydrochloride 2
Aminoethoxy)methyl]-4-(2-chlorophenyl)- O O
MM0383.04 O O
6-methylpyridine-3,5-dicarboxylate
113994-41-5 100mg Cl
Aminoethoxy)methyl]-4-(2-chlorophenyl)-6-methylpyridine- O
O O
O
O
MM0383.12 2138811-33-1 100mg
3,5-dicarboxylate Fumarate Cl
HO
O
OH
MM0383.12- Aminoethoxy)methyl]-4-(2-chlorophenyl)-6-methylpyridine- O
O O
O
O
2138811-33-1 25mg
0025 3,5-dicarboxylate Fumarate Cl
HO
O
OH
methyl-1,4-dihydropyridine-3,5-dicarboxylate O O
MM0383.10
Related compound E (USP): Diethyl 2-[(2-aminoethoxy) O O
140171-65-9 100mg Cl
methyl]-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-
dicarboxylate
Impurity E (EP): Diethyl (4RS)-2-[(2-Amino-
ethoxy)methyl]-4-(2-chlorophenyl)-6- H
N
O
NH2
MM0383.10- methyl-1,4-dihydropyridine-3,5-dicarboxylate O O
methyl-1,4-dihydropyridine-3,5-dicarboxylate O O
methyl]-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-
dicarboxylate
Impurity F (EP): Dimethyl (4RS)-2-[(2-Amino-
ethoxy)methyl]-4-(2-chlorophenyl)-6- H
N
O
N H2
MM0383.09- methyl-1,4-dihydropyridine-3,5-dicarboxylate O O
methyl]-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-
dicarboxylate
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-29
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
2,6-dimethyl-1,4-dihydropyridine-3,5-di- O O
2,6-dimethyl-1,4-dihydropyridine-3,5-dicarboxylate
Impurity G (EP): Dimethyl 4-(2-Chlorophenyl)- H
N
MM0383.07- 2,6-dimethyl-1,4-dihydropyridine-3,5-di- O O
2,6-dimethyl-1,4-dihydropyridine-3,5-dicarboxylate
Impurity H (EP): 2-[[2-[[(4RS)-4-(2-Chlorophenyl)- H
N
H
N
3-(ethoxycarbonyl)-5-(methoxycarbonyl)-6- O
O
O O
O OH
MM0383.11 318465-73-5 100mg
methyl-1,4-dihydropyridin-2-yl]methoxy]ethyl]- O O
Cl
carbamoyl]benzoic Acid
Impurity H (EP): 2-[[2-[[(4RS)-4-(2-Chlorophenyl)- H
N
H
N
MM0383.11- 3-(ethoxycarbonyl)-5-(methoxycarbonyl)-6- O
O
O O
O OH
318465-73-5 25mg
0025 methyl-1,4-dihydropyridin-2-yl]methoxy]ethyl]- O O
Cl
carbamoyl]benzoic Acid
O
OH
O S
MM0383.05 Benzenesulfonic Acid 98-11-3 100mg
O
OH
O S
MM0383.05-
Benzenesulfonic Acid 98-11-3 25mg
0025
MM0383.13- O
Cl
Ethyl 4-Chloroacetoacetate 638-07-3 100mg O O
0100
H 2N
H 2N
MM0003.08- O
Methyl 3-Aminobut-2-enoate 14205-39-1 25mg
0025
O
H H
N N H
O3-Ethyl O5-Methyl 4-(2-Chlorophenyl)-2-(2- O
MM0383.14- O O O
dicarboxylate (N-Formylamlodipine)
5-Ethyl 7-Methyl 6-(2-Chlorophenyl)-8-methyl-3,4,6,7-
O
tetrahydro-2H-1,4-benzoxazine-5,7-dicarboxylate (5- NH
MM0383.15- O O
Ethyl 7-Methyl 6-(2-Chlorophenyl)-8-methyl-3,4,6,7- 496024-43-2 25mg
O O
0025 Cl
tetrahydro-2H-1,4-benzo[b][1,4]oxazine-5,7-
dicarboxylate)
MM0383.16- O
2-Chlorobenzaldehyde 89-98-5 500mg
0500 Cl
H
N N +
2-[(2-Azidoethoxy)methyl]-4-(2-chlorophenyl)-3- O N
N
MM0383.18- O O
MM0383.20- +N O
N O
N
Ethyl 4-(2-Azidoethoxy)-3-oxobutanoate 88150-45-2 100mg O O
0100
N1,N3-Di[2-[[4-(2-Chlorophenyl)-3-ethoxycarbonyl-5- H
N
H
N
H
N
H
N
MM0383.25- O
O
O O O
O
O O
2309467-38-5 25mg O O O O
methoxycarbonyl-6-methyl-1,4-dihydropyridin-2-yl]methoxy] Cl Cl
0025
ethyl]benzene-1,3-dicarboxamide
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-30
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
Amlodipine Maleate
H
N NH2 O
O
O O OH
Amlodipine Mesilate
H
N N H2
O
O O
O O
Amobarbital
H
O N O
NH
MM1353.00 Amobarbital 57-43-2 CS 100mg
O
OH
N
H
MM0617.01 4-Acetamido-2-diethylaminomethylphenol 121-78-8 100mg N
O
OH
N
MM0617.01- H
4-Acetamido-2-diethylaminomethylphenol 121-78-8 25mg N
0025
O
OH
Cl N
7-Chloro-4-(4-hydroxyphenylamino)-
MM0617.02 HN
quinoline
81099-86-7 100mg
OH
Cl N
MM0617.02- 7-Chloro-4-(4-hydroxyphenylamino)-
HN
quinoline
81099-86-7 25mg
0025
OH
Cl N
Cl N
MM0617.03-
4,7-Dichloroquinoline 86-98-6 25mg
0025
Cl
Cl N
HN HCl
MM0617.04 Monodesethylamodiaquine Dihydrochloride 79049-30-2 100mg HN
2
OH
Cl N
MM0617.04- HN HCl
Monodesethylamodiaquine Dihydrochloride 79049-30-2 25mg HN
2
0025 OH
Cl N
+
MM0617.08- N
O
Amodiaquine N-Oxide 102391-07-1 25mg HN
0025
OH
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-31
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
Amorolfine Hydrochloride
AND Enantiomer
N
HCl
MM3511.00 Amorolfine Hydrochloride 78613-38-4 250mg O
Amoxapine
NH
N N
MM1773.00-
Amoxapine 14028-44-5 250mg
0250 O
Cl
Amoxicillin Trihydrate
O
OH
H2O O
MM0232.00- 3
N H2 N
H
Amoxicillin Trihydrate 61336-70-7 250mg N
S
0250 H
O
HO
N H2 N
MM0232.02 dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]- 26889-93-0 100mg H
N
S
H
heptane-2-carboxylic Acid (L-Amoxicillin) HO
O
MM0232.02- 2-(4-hydroxyphenyl)acetyl]amino]-3,3- O
OH
N H2 N
dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]- 26889-93-0 25mg H
N
S
H
0025 heptane-2-carboxylic Acid (L-Amoxicillin) HO
O
thiazolidine-4-carboxylic Acid H
HN
HO
3,6-dioxopiperazin-2-yl]-5,5-dimethylthiazolidine-4-carboxylic
acid
Impurity C (EP): (4S)-2-[5-(4-Hydroxyphenyl)-
3,6-dioxopiperazin-2-yl]-5,5-dimethyl- O
OH
HO
3,6-dioxopiperazin-2-yl]-5,5-dimethylthiazolidine-4-carboxylic
acid
Impurity D (EP) as Sodium Salt: (4S)-2-[[[(2R)-
2-Amino-2-(4-hydroxyphenyl)acetyl]amino]-
carboxymethyl]-5,5-dimethylthiazolidine-4- O
O Na
+
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-32
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
HO
(Penilloic Acids of Amoxicillin)
Impurity F (EP): 3-(4-Hydroxyphenyl)- HO N
pyrazin-2-ol
MM0232.06 N
Related compound F (USP): 3-(4-Hydroxyphenyl)pyrazin-2-
126247-63-0 100mg
ol; phenylpyrazinediol HO
MM0232.06- pyrazin-2-ol
N
Related compound F (USP): 3-(4-Hydroxyphenyl)pyrazin-2-
126247-63-0 25mg
0025
ol; phenylpyrazinediol HO
H
N
glycylamoxicillin)
MM0232.07 188112-75-6 100mg N
S
H
O
HO
Related compound G (USP): (2S,5R,6R)-6-(R)-2-[(R)-2-
Amino-2-(4-hydroxyphenyl)acetamido]-2-(4-hydroxyphenyl)
acetamido-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]
heptane-2-carboxylic acid
Impurity G (EP): (2S,5R,6R)-6-[[(2R)-2-[[(2R)-2-
Amino-2-(4-hydroxyphenyl)acetyl]amino]-2-
(4-hydroxyphenyl)acetyl]amino]-3,3-dimethyl-
7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2- NH2
O
O
OH
MM0232.07- carboxylic Acid (D-(4-Hydroxyphenyl)- HO
N
H
O
H
N
glycylamoxicillin)
188112-75-6 25mg N
S
0025 H
O
HO
Related compound G (USP): (2S,5R,6R)-6-(R)-2-[(R)-2-
Amino-2-(4-hydroxyphenyl)acetamido]-2-(4-hydroxyphenyl)
acetamido-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]
heptane-2-carboxylic acid
Impurity H (EP): (2R)-2-[(2,2- O
Dimethylpropanoyl)amino]-2- NH
MM0232.08 (4-hydroxyphenyl)acetic Acid 205826-86-4 100mg OH
MM0232.08- Dimethylpropanoyl)amino]-2- NH
(4-hydroxyphenyl)acetic Acid 205826-86-4 25mg OH
0025 Related compound H (USP): (R)-2-(4-hydroxyphenyl)-2- O
HO
pivalamidoacetic acid
Impurity I (EP): (2R)-2-Amino-2-(4- NH2
hydroxyphenyl)acetic Acid OH
MM0232.09
Related compound I (USP): (R)-2-Amino-2-(4-
22818-40-2 100mg
O
HO
hydroxyphenyl)acetic acid
Impurity I (EP): (2R)-2-Amino-2-(4- NH2
MM0232.09- hydroxyphenyl)acetic Acid OH
(2R)-2-Amino-2-(4-hydroxyphenyl)- NH2
acetamide
MM0232.12 54397-23-8 100mg
O
HO
NH2
MM0232.12- (2R)-2-Amino-2-(4-hydroxyphenyl)- NH2
acetamide
54397-23-8 25mg
0025 O
HO
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-33
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
NH2
MM0232.25- O
Methyl (2S)-Amino(4-hydroxyphenyl)ethanoate Hydrochloride 127369-30-6 25mg HCl
O
0025 HO
Ampicillin Sodium
O +
O Na
O
N H2 N
MM0253.00 Ampicillin Sodium 69-52-3 500mg H
N S
H
O
O
OH
H2 O O
3 N H2 N
MM0253.15 Ampicillin Trihydrate 7177-48-2 500mg H
N S
H
O
O
Impurity A (EP): (2S,5R,6R)-6-Amino-3,3- OH
O
dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]- N
MM0026.04 551-16-6 100mg
heptane-2-carboxylic Acid
H 2N S
(6-Aminopenicillanic Acid) H
O
Impurity A (EP): (2S,5R,6R)-6-Amino-3,3- OH
O
MM0026.04- dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]- N
551-16-6 25mg
0025 heptane-2-carboxylic Acid
H 2N S
(6-Aminopenicillanic Acid) H
O
OH
Impurity C (EP): (4S)-2-(3,6-Dioxo-5-phenyl-
HN
MM0253.03- piperazin-2-yl)-5,5-dimethylthiazolidine-4- O
H
N S
49841-96-5 25mg
0025 carboxylic Acid (Diketopiperazines of N O
Ampicillin) H
[[[(2R)-2-Amino-2-phenylacetyl]amino]- O Na
N H2 HN
MM0253.04 carboxymethyl]-5,5-dimethylthiazolidine- 1642559-70-3 100mg H
N S
MM0253.04- [[[(2R)-2-Amino-2-phenylacetyl]amino]- O Na
N H2 HN
carboxymethyl]-5,5-dimethylthiazolidine- 1642559-70-3 25mg H
N S
0025 4-carboxylic Acid Sodium Salt (Penicilloic O
HO O
O
(Penilloic Acids of Ampicillin)
Impurity F (EP): (2RS,4S)-2-[[[(2R)-2-Amino-2- O
OH
O
(Penilloic Acids of Ampicillin)
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-34
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
HO N
HO N
MM0253.08-
Impurity H (EP): 3-Phenylpyrazin-2-ol 73200-73-4 25mg N
0025
NH2
Impurity L (EP): (2R)-2-Amino-2-phenylacetic OH
MM0253.12 875-74-1 100mg
Acid (D-Phenylglycine) O
NH2
MM0253.12- Impurity L (EP): (2R)-2-Amino-2-phenylacetic OH
875-74-1 25mg
0025 Acid (D-Phenylglycine) O
O
OH
O
N H2 N
MM0253.16 Ampicillin, anhydrous 69-53-4 500mg H
N S
H
O
Amprenavir
N H2
OH
H
O
N N
O O
S
Amprolium Hydrochloride
Cl N H2
HCl
+
MM1772.00 Amprolium Hydrochloride 137-88-2 250mg N N
Amylmetacresol
OH
OH
OH
MM1132.04-
Impurity D (EP): 4-Methylphenol (p-Cresol) 106-44-5 100mg
0100
Anagrelide Hydrochloride
H
N N
Cl
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-35
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
Ethyl 2-(6-Amino-2,3-dichlorobenzylamino)acetate
NH2
O
MM3250.01- Hydrochloride H
N HCl
85325-12-8 25mg Cl O
Cl
0025 Related compound A (USP): ethyl 2-(6-amino-2,3-
dichlorobenzylamino)acetate
(2-Amino-5,6-dichloroquinazolin-3(4H)-yl)acetic Acid
N N H2
Hydrochloride N HCl
MM3250.04 n/a 100mg Cl
dichloroquinazolin-3(4H)-yl)acetic acid
(2-Amino-5,6-dichloroquinazolin-3(4H)-yl)acetic Acid
N N H2
dichloroquinazolin-3(4H)-yl)acetic acid
Ethyl 2-(5,6-Dichloro-2-imino-1,2-dihydroquinazolin-3(4H)-yl) N N H2
1,2-dihydroquinazolin-3(4H)-yl)acetate
Ethyl 2-(5,6-Dichloro-2-imino-1,2-dihydroquinazolin-3(4H)-yl) N N H2
1,2-dihydroquinazolin-3(4H)-yl)acetate
Anastrozole
N
N
MM1250.00 Anastrozole 120511-73-1 250mg N
N
N
Br
O O
Impurity F (EP) as Hydrate: 4-Methylbenzenesulfonic Acid S
OH H2O
MM0598.02 6192-52-5 100mg
Hydrate (4-Methylbenzenesulphonic Acid Hydrate)
N
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-36
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
N
MM1250.09- Impurity I (EP): 2,2'-[5-(Chloromethyl)benzene-1,3-diyl]bis(2- Cl
e 120511-91-3 25mg
w
0025 methylpropanenitrile)
N
O
N
N
MM0235.09 4-Amino-1,2,4-triazole 584-13-4 100mg N
H 2N
N
MM0235.09- N
4-Amino-1,2,4-triazole 584-13-4 25mg N
0025
H 2N
MM1250.10-
5-Methylbenzene-1,3-diacetonitrile 120511-74-2 25mg
0025
N
MM1250.12- 2-[3-(2-Cyanopropan-2-yl)-5-(1H-1,2,4-triazol-1-ylmethyl) N
120512-03-0 25mg N
0025 phenyl]-2-methylpropanamide N H2
O NH2
N
MM1250.13- 2,2 -[5-(1H-1,2,4-Triazol-1-yl)methylbenzene-1,3-diyl]bis(2- N
N
120512-04-1 25mg
0025 methylpropanamide) NH2
HO O
2,2 -[5-(1H-1,2,4-Triazol-1-yl)methylbenzene-1,3-diyl]bis(2- N
MM1250.15- N
N
methylpropanoic Acid) 1338800-81-9 25mg
0025 OH
Br
MM1250.17-
5-Methyl-1,3-bis(bromomethyl)benzene 19294-04-3 25mg
0025
Br
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-37
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
Androstanolone
OH
H
MM0565.00 Androstanolone 521-18-6 250mg H H
O
H
Anecortave Acetate
O
OH
HO O
MM0187.01- H
Hydrocortisone 17-Acetate 16463-74-4 25mg O
0025 H H
O
Anise Oil
O
MM0164.03 Anisaldehyde 123-11-5 100mg
O
Antazoline Hemisulfate
MM0866.00- N O O
N S
Antazoline Hemisulfate 84803-70-3 250mg N
H
HO OH
0250 2
Antazoline Hydrochloride
MM0171.00- HCl
0250 N
H
(phenyl)amino]acetamide
Impurity A (EP) as Dihydrochloride: N-(2-Aminoethyl)-2-
MM0171.01- (benzylphenylamino)-acetamide Dihydrochloride O
n/a 25mg N
N
NH2 HCl
2
0025 Related compound A (USP): N-(2-Aminoethyl)-2-[benzyl H
(phenyl)amino]acetamide
NH
MM0171.03-
N-Benzylaniline 103-32-2 25mg
0025
N
2-Chloromethyl-4,5-dihydro-1H-imidazole HCl
MM0171.04 N
Hydrochloride
13338-49-3 100mg
H
Cl
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-38
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
N
MM0171.04- 2-Chloromethyl-4,5-dihydro-1H-imidazole HCl
N
Hydrochloride
13338-49-3 25mg
0025 H
Cl
Antazoline Phosphate
N OH
MM0561.00 Antazoline Phosphate 154-68-7 500mg N
N
HO
O
P
OH
H
Apixaban
O
NH2
N
N
O
O
N
MM3754.01- O
N
N
Apixaban Ethyl Ester 503614-91-3 25mg N
O
0025
O
O
MM3754.03-
-Valerolactam 675-20-7 100mg NH
0100
Hydrochloride Trihydrate HO O OH
O
O
MM0562.05- Apomorphine o-Quinone (6a,7-Didehydroaporphine-10,11-
18605-40-8 25mg
0025 dione) N
O
HO
MM0562.06-
Apomorphine p-Quinone 24192-17-4 25mg
0025 N
O
Apremilast
O O
NH O O
MM3907.00-
Apremilast 608141-41-9 250mg N
0250 S
O
O O
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-39
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
Aprepitant
O
NH O F F
HN
N
N O F
3-[[(2R,3R)-2-[(R)-1-[3,5-Bis(trifluoromethyl)phenyl]ethoxy]-3-
(4-fluorophenyl)morpholino]methyl]-1H-1,2,4-triazol-5(4H)- O
NH O F F
HN
N
one ((R,R,R)-Aprepitant) N O F
(trifluoromethyl)phenyl]ethoxy]-3-(4-fluorophenyl)morpholino]
methyl]-1H-1,2,4-triazol-5(4H)-one
3-[[(2R,3R)-2-[(R)-1-[3,5-Bis(trifluoromethyl)phenyl]ethoxy]-3-
(4-fluorophenyl)morpholino]methyl]-1H-1,2,4-triazol-5(4H)- O
NH O F F
HN
N
MM3251.01- one ((R,R,R)-Aprepitant) N O F
1148113-53-4 25mg
0025 Related compound A (USP): 3-[[(2R,3R)-2-[(R)-1-[3,5-Bis F
F
F
F
(trifluoromethyl)phenyl]ethoxy]-3-(4-fluorophenyl)morpholino]
methyl]-1H-1,2,4-triazol-5(4H)-one
3-[[(2S,3R)-2-[(S)-1-[3,5-Bis(trifluoromethyl)phenyl]ethoxy]-3-
(4-fluorophenyl)morpholino]methyl]-1H-1,2,4-triazol-5(4H)- O
NH O F F
HN
N
one ((S,R,S)-Aprepitant) N O F
(trifluoromethyl)phenyl]ethoxy]-3-(4-fluorophenyl)morpholino]
methyl]-1H-1,2,4-triazol-5(4H)-one
3-[[(2S,3R)-2-[(S)-1-[3,5-Bis(trifluoromethyl)phenyl]ethoxy]-3-
(4-fluorophenyl)morpholino]methyl]-1H-1,2,4-triazol-5(4H)- O
NH O F F
HN
N
MM3251.02- one ((S,R,S)-Aprepitant) N O F
172822-29-6 25mg
0025 Related compound B (USP): 3-[[(2S,3R)-2-[(S)-1-[3,5-Bis F
F
F
F
(trifluoromethyl)phenyl]ethoxy]-3-(4-fluorophenyl)morpholino]
methyl]-1H-1,2,4-triazol-5(4H)-one
Aprobarbital
H
O N O
Apronalide
O O
H 2N N
MM1673.00 Apronalide 528-92-7 250mg H
Argatroban Monohydrate
O OH
NH O
H2 N N N
H O
NH H2O
O S
MM3512.00 Argatroban Monohydrate 141396-28-3 250mg H
N
Arginine
N H2
H
NH O
N H2
MM1521.00- Impurity A (EP) as Hydrochloride: (2S)-2,6-Diaminohexanoic H2 N
O H HCl
657-27-2 250mg
0250 Acid Hydrochloride (L-Lysine Hydrochloride) O
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-40
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
N H2
Impurity B (EP): (2S)-2-Amino-5-(carbamoylamino)pentanoic H 2N
H
N OH
MM0568.01 372-75-8 100mg
Acid (Citrulline; L-Citrulline) O O
Arginine Aspartate
N H2
H
H2 N N OH
NH O
MM3575.00 Arginine Aspartate (L-Arginine L-Aspartate) 7675-83-4 250mg O NH2
OH
HO
O
Arginine Hydrochloride
NH2
H
NH
N
O
OH HCl
N H2
H
H 2N N OH
MM0568.00 Arginine (L-Arginine) 74-79-3 500mg
NH O
N H2
MM1521.00- Impurity A (EP) as Hydrochloride: (2S)-2,6-Diaminohexanoic H2 N
O H HCl
657-27-2 250mg
0250 Acid Hydrochloride (L-Lysine Hydrochloride) O
N H2
Impurity B (EP): (2S)-2-Amino-5-(carbamoylamino)pentanoic H 2N
H
N OH
MM0568.01 372-75-8 100mg
Acid (Citrulline) O O
NH2
Impurity C (EP) as Hydrochloride: (2S)-2,5- H 2N OH
MM1565.00 Diaminopentanoic Acid Hydrochloride (L-Ornithine 3184-13-2 250mg
O
Hydrochloride) HCl
Aripiprazole
H
O N O
N
MM0961.00-
Aripiprazole 129722-12-9 250mg
N
Cl
0250 Cl
H
MM0961.13- HO N O
Impurity A (EP): 7-Hydroxy-3,4-dihydroquinolin-2(1H)-one 22246-18-0 25mg
0025
H
O N O
N
MM0961.07- Impurity D (EP): 7-[4-[4-(3-Chlorophenyl)piperazin-1-yl] N
203395-82-8 25mg
0025 butoxy]-3,4-dihydroquinolin-2(1H)-one Cl
129722-25-4 25mg Cl
0025 Related compound G (USP): 7-4-[4-(2,3-dichlorophenyl) Cl
piperazin-1-yl]butoxyquinolin-2(1H)-one
573691-09-5 25mg Cl
0025 (Aripiprazole N-Oxide) Cl
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-41
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
MM0961.01- 7-(4-Hydroxybutoxy)-3,4-dihydroquinolin-2(1H)-one O
H
N O
0025 dihydroquinolin-2(1H)-one
7-(4-[4-[4-(2,3-Dichlorophenyl)piperazin-1-yl]butoxy]butoxy)-
O
MM0961.05- 3,4-dihydroquinolin-2(1H)-one N
N O N
H
O
n/a 25mg Cl
piperazin-1-yl]butoxybutoxy)-3,4-dihydroquinolin-2(1H)-one
H
O N O
Cl
MM0961.06 7-(4-Chlorobutoxy)-3,4-dihydro-2(1H)-quinolinone 120004-79-7 100mg
H
MM0961.06- O N O
Cl
7-(4-Chlorobutoxy)-3,4-dihydro-2(1H)-quinolinone 120004-79-7 25mg
0025
H
MM0961.08- HO N O
7-Hydroxy-2(1H)-quinolinone 70500-72-0 25mg
0025
H
O N O
Br
MM0961.09 7-(4-Bromobutoxy)-3,4-dihydro-2(1H)-quinolinone 129722-34-5 100mg
H
MM0961.09- O N O
Br
7-(4-Bromobutoxy)-3,4-dihydro-2(1H)-quinolinone 129722-34-5 25mg
0025
O NH2
H
MM0961.15- O N O
N-(3-Methoxyphenyl)prop-2-enamide 17208-99-0 25mg
0025
H
MM0961.19- O N O
I
7-(4-Iodobutoxy)-3,4-dihydro-2(1H)-quinolinone 952308-47-3 25mg
0025
H
MM0961.20- O N O
Br
7-(4-Bromobutoxy)-2(1H)-quinolinone 203395-59-9 25mg
0025
O
H
MM0961.25- HO
O N O
4-[(2-Oxo-3,4-dihydroquinolin-7(1H)-yl)oxy]butanoic Acid 58899-27-7 25mg
0025
H
O N O
N
MM0961.30- 7-[4-[4-(3,4-Dichlorophenyl)-1-piperazinyl]butoxy]-3,4- N
203395-75-9 25mg Cl
0025 dihydro-2(1H)-quinolinone Cl
Arprinocid
N H2
N
N
Cl
MM3689.00 Arprinocid 55779-18-5 250mg N N
Artemether
O
O H
O
MM3252.00 Artemether 71963-77-4 250mg H H
O
-Artemether ((3R,5aS,6R,8aS,9R,10R,12R,12aR)-
Decahydro-10-methoxy-3,6,9-trimethyl-3,12-epoxy-12H- O
pyrano[4,3-j]-1,2-benzodioxepin) O H
MM3252.02- O
Related compound B (USP): 71939-51-0 25mg H H
0025 (3R,5aS,6R,8aS,9R,10R,12R,12aR)-Decahydro-10-methoxy- O
3,6,9-trimethyl-3,12-epoxy-12H-pyrano[4,3-j]-1,2- O
benzodioxepin
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-42
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
Artesunate
O
Anhydrodihydroartemisinin O H
MM3253.01 82596-30-3 100mg O
Related compound C (USP): Anhydrodihydroartemisinin H H
O
O
MM3253.01- Anhydrodihydroartemisinin O H
82596-30-3 25mg O
0025 Related compound C (USP): Anhydrodihydroartemisinin H H
O
Articaine Hydrochloride
O
O
H
O
N
H
HCl
O
O
MM0369.11- H
N
Articaine 23964-58-1 250mg N
S H
0250 O
thiophene-2-carboxylate Hydrochloride O
H
N
N
(Acetamidoarticaine Hydrochloride)
MM0369.01 n/a 100mg S H
O
O
N
H
O
N
H
0025 Hydrochloride (Articaine Isopropyl Ester
Hydrochloride)
Impurity D (EP) as Hydrochloride: Methyl O
MM0369.04- 3-[[(2RS)-2-(Ethylamino)propanoyl]amino]- O
H
N
N HCl
2602451-79-4 25mg
4-methylthiophene-2-carboxylate
S H
O
0025
Hydrochloride (Ethylarticaine Hydrochloride)
O
N
H
HCl
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-43
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
O
N
H
Hydrochloride)
Related compound E (USP): Methyl 3-[2-(isopropylamino)
propanamido]-4-methylthiophene-2-carboxylate
Impurity E (EP) as Hydrochloride: Methyl
4-Methyl-3-[[(2RS)-2-[(1-methylethyl)amino]-
MM0369.05- propanoyl]amino]thiophene-2-carboxylate O
O
H HCl
O
N
H
0025 Hydrochloride)
Related compound E (USP): Methyl 3-[2-(isopropylamino)
propanamido]-4-methylthiophene-2-carboxylate
Impurity F (EP) as Hydrochloride: 4-Methyl-
N-propyl-3-[[(2RS)-2-(propylamino)- H
N
O
H
HCl
O
N
H
O
Impurity I (EP): Methyl 3-Amino-4- O
MM0369.09- N H2
methylthiophene-2-carboxylate 85006-31-1 25mg
S
0025 (3-Aminoarticaine)
Ascorbic Acid
OH
O
O
MM0166.00 L-Ascorbic Acid 50-81-7 500mg HO H
HO OH
O
MM0397.02- Impurity A (EP): 2-Furaldehyde (Furane-2-carbaldehyde, O
98-01-1 500mg
0500 Furfural)
O OH
OH
MM0166.08- Impurity C (EP) as Monohydrate: L-xylo-Hex-2-ulosonic Acid HO H2O
219905-82-5 25mg O
0025 Monohydrate (L-Sorbosonic Acid Monohydrate) OH
HO
O O
OH
MM0166.09- Impurity D (EP): Methyl L-xylo-Hex-2-ulosonate (Methyl L- HO
3031-98-9 25mg O
0025 Sorbosonate) OH
HO
O OH
MM0928.01 Impurity E (EP): Oxalic Acid 144-62-7 500mg
O OH
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-44
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
O OH
H 2O
MM0928.00 Impurity E (EP) as Dihydrate: Oxalic Acid Dihydrate 6153-56-6 500mg 2
O OH
OH
O
MM0166.10- Impurity F (EP): (5R)-5-[(1R)-1,2-Dihydroxyethyl]-3,4- O
89-65-6 100mg HO H
0100 dihydroxyfuran-2(5H)-one (D-Isoascorbic Acid)
HO OH
O OH
MM0166.05- HO
L-(-)-Sorbose 87-79-6 25mg OH
0025 OH OH
Ascorbyl Palmitate
OH
O O O
H
MM1999.00- O
Ascorbyl Palmitate 137-66-6 250mg HO OH
0250
Asenapine Maleate
AND Enantiomer
N O
O O
Asparagine Monohydrate
O N H2
O NH2
Impurity A (EP): (2S)-2-Aminobutanedioic Acid (Aspartic OH
MM0567.00 56-84-8 500mg HO
Acid) O
NH2
Impurity B (EP): (2S)-2-Aminopentanedioic Acid (Glutamic HO OH
MM1333.00 56-86-0 250mg
Acid) O O
O
MM0460.10- HO
Impurity D (EP): (2E)-But-2-enedioic Acid (Fumaric Acid) 110-17-8 250mg OH
0250 O
NH2
MM0169.00- Impurity E (EP): (2S)-2,5-Diamino-5-oxopentanoic Acid (L- H 2N OH
56-85-9 250mg
0250 Glutamine) O O
MM0765.01- O HN
Phenylacetylasparagine 2752-49-0 25mg OH
0025 H 2N
O
Aspartame
O N H2 O
H
N
HO O
dioxopiperazin-2-yl]acetic acid
O N H2 O
H
N
HO OH
O N H2 O
H
N
MM0314.02- HO OH
Impurity B (EP): L-Aspartyl-L-phenylalanine 13433-09-5 25mg O
0025
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-45
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
NH2
Impurity C (EP): (2S)-2-Amino-3-phenylpropanoic Acid (L- OH
MM1560.00 63-91-2 250mg
Phenylalanine)
O
NH2
Impurity C (EP) as Racemate: 2-Amino-3-phenylpropanoic OH
MM0314.03 150-30-1 100mg
Acid (Phenylalanine)
O
NH2
MM0314.03- Impurity C (EP) as Racemate: 2-Amino-3-phenylpropanoic OH
150-30-1 25mg
0025 Acid (Phenylalanine)
O
H
N O
H
N O
MM0314.04-
Piperazine-2,5-dione (Glycine Anhydride) 106-57-0 25mg
0025
O N
H
O
MM0314.06- O HCl
L-Phenylalanine Methyl Ester Hydrochloride 7524-50-7 25mg NH2
0025
Aspartic Acid
O NH2
OH
MM0567.00 Aspartic Acid 56-84-8 500mg HO
O
O
Impurity A (EP): (2RS)-2-Hydroxybutanedioic Acid (Malic HO
MM1332.00 6915-15-7 250mg OH
Acid) O OH
O
MM0460.10- HO
Impurity B (EP): (2E)-But-2-enedioic Acid (Fumaric Acid) 110-17-8 250mg OH
0250 O
NH2
Impurity C (EP): (2S)-2-Aminopentanedioic Acid (Glutamic HO OH
MM1333.00 56-86-0 250mg
Acid) O O
NH2
OH
MM0566.00 Impurity D (EP): (2S)-2-Aminopropanoic Acid (Alanine) 56-41-7 500mg
O
O
MM0567.05- HO
Impurity E (EP): Butanedioic Acid (Succinic Acid) 110-15-6 100mg OH
0100 O
NH2
MM0169.00- Impurity F (EP): (2S)-2,5-Diamino-5-oxopentanoic Acid (L- H 2N OH
56-85-9 250mg
0250 Glutamine) O O
O N H2
Impurity G (EP) as Monohydrate: (2S)-2,4-Diamino-4- OH H2O
MM0765.00 5794-13-8 250mg H2 N
oxobutanoic Acid Monohydrate (Asparagine Monohydrate) O
MM1439.00- OH
Impurity H (EP): (2Z)-But-2-enedioic Acid (Maleic Acid) 110-16-7 250mg
0250 OH
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-46
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
Atazanavir Sulfate
N
N
H
O
H
N
OH
N
N
H
O
H
N
O
O
HO
O
S
O
OH
MM3514.06-
Impurity B (EP): 4-(Pyridin-2-yl)benzaldehyde 127406-56-8 25mg
0025
N
amino]-3,3-dimethylbutanoic acid
Atenolol
OH
H
O N
OH
Impurity A (EP): 2-(4-Hydroxyphenyl)- O
MM0013.03 17194-82-0 100mg
acetamide H2 N
OH
MM0013.03- Impurity A (EP): 2-(4-Hydroxyphenyl)- O
17194-82-0 25mg
0025 acetamide H2 N
phenyl]acetamide
Impurity B (EP): 2-[4-[(2RS)-2,3-Dihydroxy-
OH
MM0013.05- propoxy]phenyl]acetamide O
O OH
phenyl]acetamide
O
2-[4-[[(2RS)-Oxiran-2-yl]methoxy]phenyl]- O
O
acetamide
MM0013.01 29122-69-8 100mg H 2N
O
MM0013.01- 2-[4-[[(2RS)-Oxiran-2-yl]methoxy]phenyl]- O
O
acetamide
29122-69-8 25mg
0025 H 2N
OH
MM0013.06- Impurity D (EP): 2-[4-[(2RS)-3-Chloro-2- O
O Cl
115538-83-5 25mg
0025 hydroxypropoxy]phenyl]acetamide H2 N
0025
diyl)bis(oxy)]bis(4,1-phenylene)diacetamide
Impurity F (EP): 2,2'-[[(1-Methylethyl)-
imino]bis[(2-hydroxypropane-3,1- OH OH
N H2
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-47
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
hydroxypropoxy]phenylacetamide
Impurity J (EP): 2-[4-[(2RS)-3-Amino-2-hydroxypropoxy] OH
MM0013.18- O
O N H2
O
O
MM0013.09 2-[4-[(Oxiran-2-yl)methoxy]phenyl]acetonitrile 35198-42-6 100mg N
O
MM0013.09- O
2-[4-[(Oxiran-2-yl)methoxy]phenyl]acetonitrile 35198-42-6 25mg N
0025
OH
O Cl
MM0013.10 2-[4-(3-Chloro-2-hydroxypropoxy)phenyl]acetonitrile 142037-04-5 100mg N
O
O
HO
O
MM0013.11- O
0025 HO
OH
O
MM0013.13 4-Hydroxyphenylacetic Acid 156-38-7 100mg
HO
OH
MM0013.13- O
4-Hydroxyphenylacetic Acid 156-38-7 25mg
0025 HO
OH
O
MM0013.14 Methyl 4-Hydroxyphenylacetate 14199-15-6 100mg
O
OH
MM0013.14- O
Methyl 4-Hydroxyphenylacetate 14199-15-6 25mg
0025 O
Atomoxetine Hydrochloride
O N
H
OH
MM1304.05- Impurity E (EP): (2S)-2-Hydroxy-2-phenylacetic Acid (L- OH
17199-29-0 25mg
0025 Mandelic Acid) O
OH
OH
MM0256.01-
Impurity H (EP): (1RS)-3-(Methylamino)-1-phenylpropan-1-ol 42142-52-9 25mg N
H
0025
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-48
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
(1R)-3-(Methylamino)-1-phenylpropan-1-ol
MM1304.06 Related compound A (USP): 3-(Methylamino)-1- 115290-81-8 100mg
phenylpropan-1-ol HO N
H
(1R)-3-(Methylamino)-1-phenylpropan-1-ol
MM1304.06-
Related compound A (USP): 3-(Methylamino)-1- 115290-81-8 25mg
0025
phenylpropan-1-ol HO N
H
O OH O
N N OH
F
2
N O
amide 148146-51-4 25mg H O
F
0025 Related compound D (USP): Epoxide impurity, or 3-(4- O
Fluorobenzoyl)-2-isobutyryl-3-phenyl-oxirane-2-carboxylic
O OH O
MM0400.28- (phenylcarbamoyl)-1H-pyrrol-1-yl]-3,5-dihydroxyheptanoic N
H
N OH
Ca
2+
Atorvastatin
Impurity G (EP) as Calcium Salt: (3R,5R)-7-[2-(4-)-5-(1- O
methylethyl)-3-phenyl-4- N
O
N
OH
O
O
(phenylcarbamoyl)-1H-pyrrol-1-yl]-5-hydroxy- H 2+
Ca
MM0400.12 887196-29-4 100mg
-methoxyheptanoic Acid Calcium Salt F
2
MM0400.12- methylethyl)-3-phenyl-4- N
O
N
OH
O
O
(phenylcarbamoyl)-1H-pyrrol-1-yl]-5-hydroxy- H 2+
Ca
887196-29-4 25mg
0025 -methoxyheptanoic Acid Calcium Salt F
2
pyran-2-yl]ethyl-2-isopropyl-N,4-diphenyl-1H-pyrrole-3-
carboxamide
Impurity H (EP): (4R,6R)-6-[2-[2-(4-Fluorophenyl)-
5-(1-methylethyl)-3-phenyl-4-(phenylcarbamoyl)-
1H-pyrrol-1-yl]ethyl]-4-hydroxytetrahydro-2H- O O
O
pyran-2-yl]ethyl-2-isopropyl-N,4-diphenyl-1H-pyrrole-3-
carboxamide
Impurity I (EP): tert-Butyl [(4R,6R)-6-[2-[2-(4-Fluorophenyl)-3-
phenyl-4-(phenylcarbamoyl)-5-(propan-2-yl)-1H-pyrrol-1-yl]
ethyl]-2,2-dimethyl-1,3-dioxan-4-yl]acetate (1,1-Dimethylethyl
(4R-cis)-6-[2-[2-(4-Fluorophenyl)-5-(1-methylethyl)-3-phenyl- O O O O
MM0400.04- N
H
N O
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-49
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
N N OH
H
MM0400.02 phenyl-4-(phenylcarbamoyl)-5-(propan-2-yl)-1H-pyrrol-1-yl]- 345891-62-5 100mg
3,5-dihydroxyheptanoate (Atorvastatin Methyl Ester) F
MM0400.02- N
H
N OH
N N OH
H
MM0400.30 (phenylcarbamoyl)-5-(propan-2-yl)-1H-pyrrol-1-yl]-3,5- 1146977-93-6 100mg
dihydroxyheptanoate (Atorvastatin Ethyl Ester) F
MM0400.30- N
H
N OH
MM0400.35- N
H
N OH
MM0400.41- N N OH
H
1-[2-[(2S)-3,6-Dihydro-6-oxo-2H-pyran-2-yl]- O O
ethyl]-5-(4-fluorophenyl)-2-(1-methylethyl)- N
H
N
N,4-diphenyl-1H-pyrrole-3-carboxamide
MM0400.13 442851-50-5 100mg
(Atorvastatin eliminated Lactone) F
1-[2-[(2S)-3,6-Dihydro-6-oxo-2H-pyran-2-yl]- O O
MM0400.13- ethyl]-5-(4-fluorophenyl)-2-(1-methylethyl)- N
H
N
N,4-diphenyl-1H-pyrrole-3-carboxamide
442851-50-5 25mg
0025
(Atorvastatin eliminated Lactone) F
O OH O
MM0400.31- N
H
N OH
O
MM0400.32 4-Methyl-3-oxo-N-phenylpentanamide 124401-38-3 100mg N O
H
O
MM0400.32-
4-Methyl-3-oxo-N-phenylpentanamide 124401-38-3 25mg N O
0025 H
MM0400.33- N O
2-Benzylidene-4-methyl-3-oxo-N-phenylpentanamide 125971-57-5 25mg H
0025
O O
2-[2-(4-Fluorophenyl)-2-oxo-1-phenylethyl]-4-methyl-3-oxo-N- O
N
MM0400.03 phenylpentanamide (4-Fluoro-a-(2-methyl-1-oxopropyl)-?- 125971-96-2 100mg H
oxo-N,ß-diphenylbenzenebutanamide)
F
O O
2-[2-(4-Fluorophenyl)-2-oxo-1-phenylethyl]-4-methyl-3-oxo-N- O
MM0400.03- N
phenylpentanamide (4-Fluoro-a-(2-methyl-1-oxopropyl)-?- 125971-96-2 25mg H
0025
oxo-N,ß-diphenylbenzenebutanamide)
F
O OH NH2
MM0400.39- N
H
N OH
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-50
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
Atosiban Acetate
O
O
H
N
N
H
O
Atosiban Acetate
H2 N S O NH
S O
MM3515.00 O
914453-95-5 100mg H 2N
O
H
N
N
N
NH OH
H
N O H 2N
H O
O
O
O
OH
Atovaquone
Cl
Cl
MM3007.07-
trans-4-(4-Chlorophenyl)cyclohexanecarboxylic Acid 49708-81-8 25mg O
0025
OH
Atracurium Besilate
O
+
N
O
O O
O
O O
O S
O
O +
N
O O
S
MM0858.13 Impurity J (EP): Methyl Benzenesulphonate 80-18-2 100mg O
Atropine
AND Enantiomer
H
O
OH H
AND Enantiomer
H
MM0289.00-
Atropine Sulphate
O O
H
N HO S OH H2 O
5908-99-6 250mg O
O
OH H
0250 2
8-Methyl-8-azabicyclo[3.2.1]oct-3-yl O
H
O
N
HCl
MM0289.01 5978-81-4 100mg
2-Phenylpropenoate Hydrochloride H
(Apoatropine Hydrochloride)
Impurity A (EP) as Hydrochloride: (1R,3r,5S)- H
MM0289.01- 8-Methyl-8-azabicyclo[3.2.1]oct-3-yl O
H
O
N
HCl
5978-81-4 25mg
0025 2-Phenylpropenoate Hydrochloride H
(Apoatropine Hydrochloride)
O
Impurity C (EP): (2RS)-3-Hydroxy-2-phenylpropanoic
MM0601.03 552-63-6 100mg OH
Acid (Tropic Acid)
OH
O
MM0601.03- Impurity C (EP): (2RS)-3-Hydroxy-2-phenylpropanoic
552-63-6 25mg OH
0025 Acid (Tropic Acid)
OH
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-51
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
O
MM0289.03-
Atropic Acid 492-38-6 25mg OH
0025
AND Enantiomer
H
MM0289.19- O
H +
4574-60-1 25mg O N HCl
Atropine N-Oxide Hydrochloride O
0025 OH H
Avanafil
OH
N
N N
Azacitidine
NH2
N N
O N
MM1259.00 Azacitidine 320-67-2 250mg
O OH
OH
OH
NH2
O
O
1-O-Acetyl-2,3,5-tri-O-benzoyl- -D-ribofuranose O
O
MM1259.03 Related compound B (USP): 1-O-Acetyl-2,3,5-tri-O-benzoyl- 6974-32-9 100mg O
O
O
Beta-D-ribofuranose
O
O
O
1-O-Acetyl-2,3,5-tri-O-benzoyl- -D-ribofuranose O
MM1259.03- O
0025 O
O
Beta-D-ribofuranose
O
NH
O N N H2
MM1259.05- O N N
5'-O-Formylazacitidine n/a 25mg O
0025 O HO
OH
O
O O
O O
MM1259.06-
1,2,3,5-Tetra-O-acetyl- -D-ribofuranose 13035-61-5 25mg O
0025 O
O
O
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-52
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
N H2
N N
4-Amino-1-[2,3-O-(1-methylethylidene)- -D-ribofuranosyl]- O N
MM1259.09-
1,3,5-triazin-2(1H)-one (2',3'-O-(1-methylethylidene) 65370-90-3 25mg
0025 O O
azacitidine)
O
OH
Azaperone
F
Azaperone
N
MM1164.00 1649-18-9 250mg O N
F
O
MM1164.01- +
N
Azaperone N-Oxide 66065-28-9 25mg O N
0025 N
Azapropazone
O
+
MM0245.06- N
4-Methyl-2-nitroaniline 89-62-3 25mg O
0025
NH2
Azathioprine
O
+
N
N O
N N
O
+
N
Impurity A (EP): 1-Methyl-4-nitro-1H-imidazol-5-amine N O
MM1532.07-
Related compound A (USP): 1-methyl-4-nitro-1H-imidazol-5- 4531-54-8 25mg
0025
amine N N H2
SH
H
MM1537.00- Impurity B (EP) as Monohydrate: 7H-Purine-6-thiol N
N
6112-76-1 250mg H2 O
0250 Monohydrate (Mercaptopurine Monohydrate) N
N
O
+
N N
O
MM1532.01 Impurity C (EP): 5-Chloro-1-methyl-4-nitro-1H-imidazole 4897-25-0 100mg
N
Cl
O
+
N N
MM1532.01- O
Impurity C (EP): 5-Chloro-1-methyl-4-nitro-1H-imidazole 4897-25-0 25mg
0025
N
Cl
O
+
N
MM1532.08- N O
Impurity D (EP): 1-Methyl-4-nitro-1H-imidazole-5-thiol 6339-54-4 25mg
0025
N SH
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-53
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
N
HN
MM1047.01 Impurity F (EP): 1,7-Dihydro-6H-purin-6-one (Hypoxanthine) 68-94-0 100mg
N N
H
N
MM1047.01- HN
Impurity F (EP): 1,7-Dihydro-6H-purin-6-one (Hypoxanthine) 68-94-0 25mg
0025
N N
H
O
+
N
Impurity G (EP): 6-[(1-Methyl-4-nitro-1H-imidazol-5-yl) N O
sulfanyl]-7H-purin-2-amine (Thiamiprine) N
MM1292.00 5581-52-2 100mg S
Related compound G (USP): 6-[(1-methyl-4-nitro-1H- H
N
N
imidazol-5-yl)thio]-9H-purin-2-amine
H 2N N N
O
+
N
N O
MM1532.04- N
7-Methylazathioprine 302840-04-6 25mg S
0025
N
N
N N
O
+
N
N O
N S
MM1532.05 9-Methylazathioprine 304441-06-3 100mg
N
N
N N
O
+
N
N O
MM1532.05- N S
9-Methylazathioprine 304441-06-3 25mg
0025 N
N
N N
O
+
N
N O
N N
S
H
N
MM0865.00 Thioguanine 154-42-7 250mg HN
H 2N N N
Azelaic Acid
O O
Azelastine Hydrochloride
O
N
HCl
N
MM0362.00-
Azelastine Hydrochloride 79307-93-0 250mg N
0250
Cl
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-54
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
O
MM0362.04-
Impurity A (EP): Benzoyldiazane (Benzohydrazide) 613-94-5 25mg NH
0025 NH2
OH
O
MM0362.05 Impurity C (EP): 2-[(4-Chlorophenyl)acetyl]benzoic Acid 53242-76-5 100mg
Cl
OH
MM0362.05- O
Impurity C (EP): 2-[(4-Chlorophenyl)acetyl]benzoic Acid 53242-76-5 25mg
0025
Cl
NH
Impurity D (EP): 4-(4-Chlorobenzyl)phthalazin-1(2H)-one N
MM0362.01 Related compound D (USP): 4-(4-chlorobenzyl)phthalazin-1 53242-88-9 100mg
(2H)-one
Cl
NH
Impurity D (EP): 4-(4-Chlorobenzyl)phthalazin-1(2H)-one N
MM0362.01-
Related compound D (USP): 4-(4-chlorobenzyl)phthalazin-1 53242-88-9 25mg
(2H)-one
0025
Cl
(3H)-one
Related compound E (USP): 3-(4-chlorobenzylidene)
MM0362.08 20526-97-0 100mg O
isobenzofuran-1(3H)-one O
MM0362.08- (3H)-one
Related compound E (USP): 3-(4-chlorobenzylidene)
20526-97-0 25mg O
0025
isobenzofuran-1(3H)-one O
HCl
MM0362.03 1-Methylazepan-4-one Hydrochloride 19869-42-2 100mg N
O
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-55
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
Azilsartan
N
O O
N O
MM3924.00- HN N
Azilsartan 147403-03-0 250mg O OH
0250
Azithromycin
N
OH
HO HO
O O
O
HO O
H
N
OH
HO HO
(Azaerythromycin A) N O
HO O
OH
HO O
OH
HO HO
MM1075.11- demethylazithromycin H
N
O O
O
OH O O
sulfonyl]-3'-N-demethylazithromycin HO O
N
OH
HO HO
O O
MM1075.10- O
0025 N O
O
HO O
Azorubine
O O
S
OH O
+
N Na
MM3706.00- N
Azorubine 3567-69-9 250mg
0250 O S +
O Na
O
Baclofen
H2 N
O
Cl
Cl
Cl
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-56
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
HO O
MM1235.01 3-(4-Chlorophenyl)glutaric Acid 35271-74-0 100mg OH
Cl
MM1235.01- HO O
3-(4-Chlorophenyl)glutaric Acid 35271-74-0 25mg OH
0025
Cl
H 2N
O
MM1235.07- HCl
Baclofen Methyl Ester Hydrochloride 213407-11-5 25mg O
0025 Cl
H 2N
O
MM1235.08- HCl
204503-99-1 25mg O
Baclofen Ethyl Ester Hydrochloride
0025 Cl
H 2N
O
MM1235.09- HCl
1332869-11-0 25mg O
Baclofen Isopropyl Ester Hydrochloride
0025 Cl
NH
MM1235.11-
4-(4-Chlorophenyl)piperidine-2,6-dione 84803-46-3 25mg O
0025
Cl
O
MM1235.12-
4-(4-Chlorophenyl)tetrahydropyran-2,6-dione 53911-68-5 25mg O
0025
Cl
Bambuterol Hydrochloride
OH
H
N O N
HCl
N O
OH
N O
O
N O
O
N O
Bamethan Sulfate
OH
H
O O
Bamethan Sulfate
N
S
MM1822.00 5716-20-1 100mg HO OH
HO
2
Bamifylline Hydrochloride
N OH
O
O N N
O
+
N OH
O
MM1823.01- N
Bamifylline N-Oxide n/a 25mg N
0025 O N N
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-57
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
Barbital
H
O N O
Barbital Sodium
H +
O N O Na
Baricitinib
O O
S
N
N N
MM3905.00-
Baricitinib 1187594-09-7 250mg N
0250
N
N N
H
O
Impurity C (EP): 2-(Dimethylamino)ethyl N
MM0753.03 2867-47-2 100mg O
Methacrylate
Bazedoxifene Acetate
HO
OH
N
OH
Beclamide
O
Beclometasone Dipropionate
O
O
O O
Cl H
O
methyl-3,20-dioxopregna-1,4-dien-21-yl O
O
16Beta-methyl-3,20-dioxopregna-1,4-diene-21-yl propionate
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-58
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
MM0199.02- methyl-3,20-dioxopregna-1,4-dien-21-yl O
O
16Beta-methyl-3,20-dioxopregna-1,4-diene-21-yl propionate
O
Impurity B (EP): 21-(Acetyloxy)-9-chloro-11 - O
O
O
Acetate 17-Propionate) O
O
Impurity B (EP): 21-(Acetyloxy)-9-chloro-11 - O
O
O
MM0199.06- hydroxy-16 -methyl-3,20-dioxopregna-1,4- 5534-08-7 25mg HO O
H
0025 dien-17-yl Propanoate (Beclometasone 21- Cl H
Acetate 17-Propionate) O
Cl H
17-Propionate) O
O
MM0199.05- 3,20-dioxo-17-(propanoyloxy)-pregna-1,4-dien- n/a 25mg HO O
17-Propionate) O
16Beta-methyl-3,20-dioxopregna-1,4-diene-17-yl propionate
Impurity H (EP): 9-Chloro-11 ,21-dihydroxy-16 - OH
O
MM0199.01- methyl-3,20-dioxopregna-1,4-dien-17-yl HO O
O
16Beta-methyl-3,20-dioxopregna-1,4-diene-17-yl propionate
OH
O
OH
O
Bemegride
O
Benactyzine Hydrochloride
OH O
OH O
MM1826.02-
Benactyzine N-Oxide 42771-70-0 25mg O
+
0025 N O
Benazepril Hydrochloride
O
H OH
N
MM1229.00- N
Benazepril Hydrochloride 86541-74-4 250mg HCl
O O
O
0250
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-59
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
O
Related compound D (USP): 3-(1-Ethoxycarbonyl-3-
n/a 25mg O O
0025
cyclohexyl-(1S)-propyl)amino-2,3,4,5-tetrahydro-2-oxo-1H-1-
(3S)-benzazepine-1-acetic acid
Impurity E (EP) as Hydrochloride: [(3S)-3-Amino-2-oxo-
O
2,3,4,5-tetrahydro-1H-1-benzazepin-1-yl]acetic Acid H 2N
N
OH
MM1229.07- HCl
Hydrochloride n/a 25mg O
MM1229.03- 2-oxo-2,3,4,5-tetrahydro-1H-1-benzazepin-1- H2 N
N
O
O
H O
MM1229.10- N
N
O
Benazepril Isopropyl Ester n/a 25mg O O
0025
O
H O
N
MM1229.12- N
O
Benazepril tert-Butyl Ester 109010-61-9 100mg O O
0100
Bendamustine Hydrochloride
O
OH
N
5-[Bis(2-hydroxyethyl)amino]-1-methyl-1H-benzimidazole-2- N
O
O
MM0154.02- 5-[Bis(2-hydroxyethyl)amino]-1-methyl-1H-benzimidazole-2- N
O
O
MM0154.03
Ester
3543-73-5 100mg
H2 N N
3543-73-5 25mg
0025 Ester H2 N N
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-60
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
O
O
MM0154.04- N
Ethyl 4-(1-Methyl-5-nitrobenzimidazol-2-yl)butanoate 3543-72-4 25mg O
N
+ N
0025 O
NH
NH
MM0154.50-
N'-Methyl-2,4-dinitroaniline 2044-88-4 25mg O + +O
0025 N N
O O
NH
MM0154.51-
N-Methyl-2-amino-4-nitroaniline 41939-61-1 25mg O +
0025 N NH2
O
N O
MM0154.53 Ethyl 5-(1-Methyl-5-nitro-benzimidazol-2-yl)pentanoate 3543-76-8 100mg O + N
N
O
MM0154.53- N O
Ethyl 5-(1-Methyl-5-nitro-benzimidazol-2-yl)pentanoate 3543-76-8 25mg O + N
0025 N
O
O
MM0154.54-
N O
Ethyl 5-(5-Amino-1-methylbenzimidazol-2-yl)pentanoate 3543-77-9 25mg
0025 H2 N N
O
O
MM0154.19- N
Bendamustine 1-Methylethyl Ester 1313020-25-5 25mg Cl
N N
0025 Cl
Bendroflumethiazide
O O O O
S S
H2 N NH
MM0674.00 Bendroflumethiazide 73-48-3 100mg F
N
H
F F
O O O O
S S
Impurity A (EP): 4-Amino-6-(trifluoromethyl)benzene- H 2N NH2
MM0674.01 654-62-6 100mg F
1,3-disulphonamide NH2
F F
O O O O
S S
MM0674.01- Impurity A (EP): 4-Amino-6-(trifluoromethyl)benzene- H 2N NH2
654-62-6 25mg F
0025 1,3-disulphonamide NH2
F F
Benfluorex Hydrochloride
F
0025 Benzoate Hydrochloride F
Methyl-2-[4-(trifluoromethyl)phenyl]ethyl]-
O HCl
22444-70-8 25mg F
F F
0025 amino]ethyl Benzoate Hydrochloride
O
MM0278.01-
Impurity C (EP): Benzoic Acid 65-85-0 250mg OH
0250
O
O
MM1298.06- Impurity F (EP): 2-[Benzoyl[(1RS)-1-methyl-2-[3-(tri- N
O
n/a 25mg
0025 fluoromethyl)phenyl]ethyl]amino]ethyl Benzoate
F
F
F
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-61
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
Benorilate
O
H
N
O O
Benoxaprofen
OH
MM1828.00 Benoxaprofen 51234-28-7 50mg Cl
N
O
O
MM1828.01- N O
Benoxaprofen Methyl Ester 87498-09-7 25mg Cl
O
O
0025
MM1828.02- N O
n/a 25mg N O OH
0025 and Stereoisomers) Cl
O
O
Benperidol
O
H
N
N
O
H
N
Impurity A (EP): 1-(Piperidin-4-yl)-1,3- N
MM0113.03 20662-53-7 100mg
dihydro-2H-benzimidazol-2-one
HN
O
H
N
MM0113.03- Impurity A (EP): 1-(Piperidin-4-yl)-1,3- N
20662-53-7 25mg
0025 dihydro-2H-benzimidazol-2-one
HN
O
H
N
O
Cl
MM0113.07 4-Chloro-4'-fluorobutyrophenone 3874-54-2 100mg
F
Benserazide Hydrochloride
NH2
H
N OH
N
MM1282.00 Benserazide Hydrochloride 14919-77-8 250mg HO OH
H
O
HCl
OH
N H2
MM1282.01- Impurity A (EP) as Hydrochloride: (2RS)-2-Amino-3- H
N OH HCl
55819-71-1 25mg H2 N
0025 hydroxypropanohydrazide Hydrochloride O
Benzalkonium Chloride
Cl
MM0795.00- OH
Impurity A (EP): Benzyl Alcohol 100-51-6 250mg
0250
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-62
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
MM0528.05- O
Impurity B (EP): Benzaldehyde 100-52-7 500mg
0500
MM0224.06-
Impurity C (EP): (Chloromethyl)benzene 100-44-7 500mg
0500 Cl
Cl
Cl
Cl
N
MM0451.05 Dimethyldodecylamine 112-18-5 100mg
Benzbromarone
O
Br
Benzethonium Chloride
+
O N
Benzocaine
O
MM0094.00- O
Benzocaine 94-09-7 250mg
0250 H2 N
NH2
NH2
MM0147.04-
Impurity B (EP): (2-Aminophenyl)methanol 5344-90-1 25mg OH
0025
Methanesulfonate)
O
MM1255.01- OH
Impurity E (EP): 4-Nitrobenzoic Acid 62-23-7 25mg O +
0025 N
O
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-63
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
O
MM1255.07- O
Impurity H (EP): Methyl 4-Aminobenzoate 619-45-4 25mg
0025 H2 N
O O
MM0094.01-
Benzocaine Acetylsalicylamide 23437-10-7 25mg N
H
0025 O
O O
MM0094.02 N-Acetylbenzocaine 5338-44-3 100mg
N
H
MM0094.02- O O
N-Acetylbenzocaine 5338-44-3 25mg
0025 N
H
O
MM0094.04 Ethyl 4-Nitrobenzoate 99-77-4 100mg O +
N
O
MM0094.04- O
Ethyl 4-Nitrobenzoate 99-77-4 25mg O +
0025 N
O
O O
MM0094.05 Ethyl 4-Formamidobenzoate (N-Formylbenzocaine) 5422-63-9 100mg
N
H
MM0094.05- O O
Ethyl 4-Formamidobenzoate (N-Formylbenzocaine) 5422-63-9 25mg
0025 N
H
Benzoxonium Chloride
HO
OH
5
Cl
Benzthiazide
O O O O
S S
Cl N
NH
S
Benztropine Mesilate
H
O O
H
MM1227.02- H HCl
+
Benztropine N-Oxide Hydrochloride n/a 25mg O N
O
0025 H
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-64
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
Benzydamine Hydrochloride
N
N O
MM0142.00-
Benzydamine Hydrochloride 132-69-4 250mg N
HCl
0250
H
N
N O
Impurity C (EP): 1-Benzyl-1H-indazol-3-ol (1-Benzyl-1,2-
MM0142.04 2215-63-6 100mg
dihydro-3H-indazol-3-one)
H
N
N O
MM0142.04- Impurity C (EP): 1-Benzyl-1H-indazol-3-ol (1-Benzyl-1,2-
2215-63-6 25mg
0025 dihydro-3H-indazol-3-one)
+
HCl
O N
O
NH2
Benzyl Alcohol
MM0795.00- OH
Benzyl Alcohol 100-51-6 250mg
0250
MM0528.05- O
Impurity A (EP): Benzaldehyde 100-52-7 500mg
0500
OH
MM0795.02 Impurity B (EP): Cyclohexylmethanol 100-49-2 100mg
Benzyl Benzoate
O
MM0570.00- O
Benzyl Benzoate 120-51-4 250mg
0250
Benzyl Nicotinate
O
O
MM0553.00-
Nicotinic Acid 59-67-6 250mg N OH
0250
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-65
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
Benzylpenicillin Benzathine
N
H
N
MM0513.00 1538-09-6 500mg S
N H
H O
2
N H2
HN
O
MM0160.03 Impurity B (EP): Phenylacetic Acid 103-82-2 100mg
OH
MM0160.03- O
Impurity B (EP): Phenylacetic Acid 103-82-2 25mg
0025 OH
O
OH
Impurity C (EP): (4S)-2-[2-[Benzyl[2-(benzylamino)ethyl] HN
H
MM0513.08- amino]-2-oxo-1-(2-phenylacetamido)ethyl]-5,5-dimethyl-1,3- N
S
H
n/a 25mg O N
Benzathide)
O
Impurity D (EP): (3S,7R,7aR)-5-Benzyl-2,2- OH
dimethyl-2,3,7,7a-tetrahydroimidazo[5,1-b]- N
N
MM0160.07 13093-87-3 100mg
thiazole-3,7-dicarboxylic Acid H
S
HO
(Penillic Acid of Benzylpenicillin) O
O
Impurity D (EP): (3S,7R,7aR)-5-Benzyl-2,2- OH
MM0160.07- dimethyl-2,3,7,7a-tetrahydroimidazo[5,1-b]- N
N
13093-87-3 25mg
0025 thiazole-3,7-dicarboxylic Acid H
S
HO
(Penillic Acid of Benzylpenicillin) O
amino]methyl]-5,5-dimethylthiazolidine-4- H
HN
MM0160.01 13057-98-2 100mg N
carboxylic Acid (Penicilloic Acids of O
S
Benzylpenicillin) O OH
MM0160.01- amino]methyl]-5,5-dimethylthiazolidine-4- H
HN
13057-98-2 25mg N
0025 carboxylic Acid (Penicilloic Acids of O
S
Benzylpenicillin) O OH
amino]methyl]-5,5-dimethylthiazolidine-4- H
HN
MM0160.05 501-34-8 100mg N
carboxylic Acid (Penilloic Acids of O
S
Benzylpenicillin)
Impurity F (EP): (2RS,4S)-2-[[(Phenylacetyl)- O
OH
MM0160.05- amino]methyl]-5,5-dimethylthiazolidine-4- H
HN
501-34-8 25mg N
0025 carboxylic Acid (Penilloic Acids of O
S
Benzylpenicillin)
Impurity G (EP) as Sodium Salt: (2S,5R,6R)-6-[2-(4- O
O Na
+
Hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1- O
H
N
N
MM0160.06- Hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1- O
H
N
N
5985-13-7 25mg
0025 azabicyclo[3.2.0]heptane-2-carboxylic Acid Sodium Salt (4- HO
O
H
S
H
N O
MM0513.01-
N,N'-Dibenzylethylenediamine Diacetate 122-75-8 25mg N
HO
2
0025 H
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-66
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
O
Impurity A (EP): (2S,5R,6R)-6-Amino-3,3- OH
O
dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]- N
MM0026.04 551-16-6 100mg
heptane-2-carboxylic Acid
H 2N S
(6-Aminopenicillanic Acid) H
O
Impurity A (EP): (2S,5R,6R)-6-Amino-3,3- OH
O
MM0026.04- dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]- N
551-16-6 25mg
0025 heptane-2-carboxylic Acid
H 2N S
(6-Aminopenicillanic Acid) H
O
MM0160.03 Impurity B (EP): Phenylacetic Acid 103-82-2 100mg
OH
MM0160.03- O
Impurity B (EP): Phenylacetic Acid 103-82-2 25mg
0025 OH
Sodium Salt)
Impurity C (EP) as Sodium Salt: (2S,5R,6R)-6-[[(4-
MM0160.06- Hydroxyphenyl)acetyl]amino]-3,3-dimethyl-7-oxo- O
N
O
O Na
+
Sodium Salt)
O
Impurity D (EP): (3S,7R,7aR)-5-Benzyl-2,2- OH
dimethyl-2,3,7,7a-tetrahydroimidazo[5,1-b]- N
N
MM0160.07 13093-87-3 100mg
thiazole-3,7-dicarboxylic Acid H
S
HO
(Penillic Acid of Benzylpenicillin) O
O
Impurity D (EP): (3S,7R,7aR)-5-Benzyl-2,2- OH
MM0160.07- dimethyl-2,3,7,7a-tetrahydroimidazo[5,1-b]- N
N
13093-87-3 25mg
0025 thiazole-3,7-dicarboxylic Acid H
S
HO
(Penillic Acid of Benzylpenicillin) O
acetyl)amino]methyl]-5,5-dimethyl- H
HN
MM0160.01 13057-98-2 100mg N
thiazolidine-4-carboxylic Acid (Penicilloic O
S
Acids of Benzylpenicillin) O OH
MM0160.01- acetyl)amino]methyl]-5,5-dimethyl- H
HN
13057-98-2 25mg N
0025 thiazolidine-4-carboxylic Acid (Penicilloic O
S
Acids of Benzylpenicillin) O OH
amino]methyl]-5,5-dimethylthiazolidine-4- H
HN
MM0160.05 501-34-8 100mg N
carboxylic Acid (Penilloic Acids of O
S
Benzylpenicillin)
Impurity F (EP): (2RS,4S)-2-[[(Phenylacetyl)- O
OH
MM0160.05- amino]methyl]-5,5-dimethylthiazolidine-4- H
HN
501-34-8 25mg N
0025 carboxylic Acid (Penilloic Acids of O
S
Benzylpenicillin)
H
S
N H2 O
H 2N
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-67
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
acetyl)amino]methyl]-5,5-dimethyl- H
HN
MM0160.01 13057-98-2 100mg N
thiazolidine-4-carboxylic Acid O
S
MM0160.01- acetyl)amino]methyl]-5,5-dimethyl- H
HN
13057-98-2 25mg N
0025 thiazolidine-4-carboxylic Acid O
S
amino]methyl]-5,5-dimethylthiazolidine-4- H
HN
MM0160.05 501-34-8 100mg N
carboxylic Acid (Penilloic Acids of O
S
Benzylpenicillin)
Impurity C (EP): (2RS,4S)-2-[[(Phenylacetyl)- O
OH
MM0160.05- amino]methyl]-5,5-dimethylthiazolidine-4- H
HN
501-34-8 25mg N
0025 carboxylic Acid (Penilloic Acids of O
S
Benzylpenicillin)
O
Impurity D (EP): (3S,7R,7aR)-5-Benzyl-2,2- OH
dimethyl-2,3,7,7a-tetrahydroimidazo[5,1- N
N
MM0160.07 13093-87-3 100mg
b]thiazole-3,7-dicarboxylic Acid (Penillic H
S
HO
Acid of Benzylpenicillin) O
O
Impurity D (EP): (3S,7R,7aR)-5-Benzyl-2,2- OH
MM0160.07- dimethyl-2,3,7,7a-tetrahydroimidazo[5,1- N
N
13093-87-3 25mg
0025 b]thiazole-3,7-dicarboxylic Acid (Penillic H
S
HO
Acid of Benzylpenicillin) O
O
MM0160.03 Impurity E (EP): Phenylacetic Acid 103-82-2 100mg
OH
MM0160.03- O
Impurity E (EP): Phenylacetic Acid 103-82-2 25mg
0025 OH
5985-13-7 25mg N
S
H
0025 azabicyclo[3.2.0]heptane-2-carboxylic Acid (4- HO
O
Bephenium Embonate
+ O
N
O O
Bephenium Hydroxynaphthoate
+ O
N
OH
Berberine Chloride
O
O
O
O Cl
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-68
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
Berberine Hemisulfate
O
O
O O
O
2
Beta Alanine
MM3497.04- O
HCl
Beta Alanine Isopropyl Ester Hydrochloride 51871-17-1 25mg H 2N O
0025
Betahistine Dihydrochloride
H
MM0587.00- N N
Betahistine Dihydrochloride 5579-84-0 250mg HCl
0250 2
N
MM0587.01 Impurity A (EP): 2-Ethenylpyridine (2-Vinylpyridine) 100-69-6 100mg
N OH
Impurity B (EP): 2-(Pyridin-2-yl)ethanol
MM0587.02 103-74-2 100mg
(2-(2-Hydroxyethyl)pyridine)
Trihydrochloride
0025 Trihydrochloride
Impurity C (EP) as Trimesilate: N-Methyl-2-(pyridin-
N N N O O
Trimesilate
0025 Trimesilate
Betahistine Mesilate
H
N N
O O
MM0367.00 Betahistine Mesilate 54856-23-4 250mg S
OH
2
Betaine
O
MM3894.00- +
Betaine 107-43-7 1g N
1000 O
Betaine Hydrochloride
Cl
O
MM0611.00 Betaine Hydrochloride 590-46-5 500mg +
N
OH
MM0611.01- O
+
Betaine Methyl Ester Chloride 3032-10-8 25mg N Cl
O
0025
MM0611.02- O
+
Betaine Ethyl Ester Chloride 3032-11-9 25mg N Cl
O
0025
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-69
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
MM0611.03- O
+
Betaine Isopropyl Ester Chloride 110675-64-4 25mg N Cl
O
0025
O
MM3894.00- +
Betaine 107-43-7 1g N
1000 O
Betamethasone
O
OH
HO OH
F H
O
O
OH
HO OH
F H
O
F H
3,20-dione (Clobetasol) O
O
OH
Impurity E (EP): 9,11 -Epoxy-17,21-dihydroxy-16 -methyl- O
OH
O
OH
MM0200.04- Impurity E (EP): 9,11 -Epoxy-17,21-dihydroxy-16 -methyl- O
OH
981-34-0 25mg
0025 9 -pregna-1,4-diene-3,20-dione H H
O
OH
HO
MM0200.11- 9-Fluoro-11 ,21-dihydroxy-16-methylpregna-1,4,16-triene- H
59860-99-0 25mg
0025 3,20-dione F H
O
O OH
MM0213.13- OH
H
17,21-Dihydroxy-16 -methylpregna-1,4-diene-3,11,20-trione 2036-77-3 25mg
0025 H H
O
O
HO
Betamethasone-17-ketone (9a-Fluoro-11ß-hydroxy-16ß- H
MM0200.13 3109-01-1 100mg
methylandrosta-1,4-diene-3,17-dione) F H
O
O
HO
MM0200.13- Betamethasone-17-ketone (9a-Fluoro-11ß-hydroxy-16ß- H
3109-01-1 25mg
0025 methylandrosta-1,4-diene-3,17-dione) F H
O
Betamethasone Acetate
O
O
O
HO OH
MM0201.00 Betamethasone Acetate 987-24-6 250mg H
F H
O
O
OH
HO OH
F H
O
O
O
O
HO OH
MM0445.00 Impurity B (EP): Dexamethasone Acetate 1177-87-3 250mg H
F H
O
diacetate O
330157-05-6 25mg
0025 trihydroxy-16Beta-methylpregna-1,4-diene-3,20-dione 11,21- F H
diacetate O
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-70
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
Betamethasone Dipropionate
O
O
O O
F H
O
O
OH
HO OH
Impurity A (EP): 9-Fluoro-11 ,17,21-trihydroxy-16 - H
MM0200.00 378-44-9 250mg
methylpregna-1,4-diene-3,20-dione (Betamethasone) F H
O
HO OH
MM0202.04 Propionate) 75883-07-7 100mg H
F H
Related compound C (USP): 9-Fluoro-11Beta,17-dihydroxy- O
16Beta-methyl-3,20-dioxopregna-1,4-diene-21-yl propionate
Impurity C (EP): 9-Fluoro-11 ,17-dihydroxy-16 -methyl-3,20-
O
16Beta-methyl-3,20-dioxopregna-1,4-diene-21-yl propionate
O
HO O
MM0199.00 dioxopregna-1,4-diene-17,21-diyl Dipropanoate 5534-09-8 250mg H
Cl H
(Beclometasone Dipropionate) O
OH
HO
MM0200.11- 9-Fluoro-11 ,21-dihydroxy-16-methylpregna-1,4,16-triene- H
59860-99-0 25mg
0025 3,20-dione F H
O
F H
O
Betamethasone Valerate
OH
O O
HO O
F H
O
O
OH
HO OH
F H
O
3,20-dioxopregna-1,4-dien-21-yl Pentanoate O
O
16beta-methyl-3,20-dioxopregna-1,4-diene-21-yl valerate
Impurity E (EP): 9-Fluoro-11 ,17-dihydroxy-16 -methyl- O
16beta-methyl-3,20-dioxopregna-1,4-diene-21-yl valerate
Betaxolol Hydrochloride
OH
H
O N
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-71
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
OH
Impurity D (EP): 4-[2-(Cyclopropylmethoxy)ethyl]-
MM0436.04 63659-16-5 50mg
phenol O
n/a 25mg
0025 amino)propan-2-ol Hydrochloride O
Bethanechol Chloride
O
Bezafibrate
O
O
O OH
(4-Chlorobenzoyltyramine) Cl
Cl
O
MM0063.03-
Impurity B (EP): 4-Chlorobenzoic Acid 74-11-3 25mg OH
0025
Cl
methylpropanoate Cl
methylpropanoate
Cl
methylpropanoate
0025 Cl
O O
methylpropanoate
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-72
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
O O
NH2
MM0063.06-
Tyramine 51-67-2 25mg
0025 HO
Cl
N,O-Bis-(4-chlorobenzoyl)tyramine
O
O
MM0063.07 41859-56-7 100mg N
H
Cl
Cl
MM0063.07- O
N,O-Bis-(4-chlorobenzoyl)tyramine
O
O
41859-56-7 25mg N
H
0025 Cl
O
O
O O
O
O
MM0063.08- O O
Bibenzonium Bromide
O +
N
Bicalutamide
O OH O F F
H
MM0894.00- S N
0250 N
O OH O F F
H
MM0894.25- S N
F
(R)-Bicalutamide 113299-40-4 25mg O
F
0025 N
O OH O F F
H
MM0894.26- S N
F
(S)-Bicalutamide 113299-38-0 25mg F
O
0025 N
O OH O F F
MM0894.02- Impurity A (EP): (2RS)-N-[4-Cyano-3-(trifluoromethyl) S
H
N
F
90357-05-4 25mg O
0025 phenyl]-2-hydroxy-2-methyl-3-(phenylsulfonyl)propanamide N
F
phenyl]-3-[(2-fluorophenyl)sulfonyl]-2-hydroxy-2- 1159977-36-2 25mg F
O
N
0025 methylpropanamide
N
0025 (Dehydroxybicalutamide)
F F
H2 N
F
MM0894.05 Impurity D (EP): 4-Amino-2-(trifluoromethyl)benzonitrile 654-70-6 100mg
N
F F
H2 N
MM0894.05- F
Impurity D (EP): 4-Amino-2-(trifluoromethyl)benzonitrile 654-70-6 25mg
0025
N
O
N
F
N
0025 methylpropanamide
HO F F
Impurity J (EP): (2RS)-N-[4-Cyano-3-(trifluoromethyl)phenyl]- S
H
N
F
MM0894.12 90356-78-8 100mg O
3-[(4-fluorophenyl)sulfanyl]-2-hydroxy-2-methylpropanamide F
N
HO F F
MM0894.12- Impurity J (EP): (2RS)-N-[4-Cyano-3-(trifluoromethyl)phenyl]- S
H
N
F
90356-78-8 25mg O
0025 3-[(4-fluorophenyl)sulfanyl]-2-hydroxy-2-methylpropanamide F
N
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-73
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
O HO O
MM0894.15- Impurity M (EP): (2RS)-3-[(4-Fluorophenyl)sulfonyl]-2- HO S
151262-57-6 25mg
0025 hydroxy-2-methylpropanoic Acid O
F
N-[4-Cyano-3-(trifluoromethyl)phenyl]-3-[(4-
fluorophenyl)sulfinyl]-2-hydroxy-2-methyl- O HO F F
MM0894.01- propanamide S
H
N
F
0025 N
phenyl]-3-[(4-fluoro-phenyl)sulfinyl]-2-hydroxy-2-methyl-
propanamide
(RS)-N-[4-Cyano-3-(trifluoromethyl)phenyl]-3-(3-
fluorophenylsulfonyl)-2-hydroxy-2-methylpropanamide O OH O
H
F F
MM0894.08- F S N
F
Related compound B (USP): (RS)-N-[4-cyano-3- 1166228-30-3 25mg O
0025 N
(trifluoromethyl)phenyl]-3-(3-fluorophenylsulfonyl)-2-hydroxy-
2-methylpropanamide
MM0894.10- (2RS)-N-[4-Bromo-3- O OH O
H
F F
S N
0025 sulfonyl]-2-hydroxy-2-methylpropanamide
O F F
H
N
N-[4-Cyano-3-(trifluoromethyl)phenyl]-2-methyl-oxirane-2- F
MM0894.11 90357-51-0 100mg O
carboxamide N
O F F
H
N
MM0894.11- N-[4-Cyano-3-(trifluoromethyl)phenyl]-2-methyl-oxirane-2- F
90357-51-0 25mg O
0025 carboxamide N
O O OH
MM0894.16- Methyl 3-(4-Fluorophenyl)sulfonyl-2-hydroxy-2- S O
512776-93-1 25mg O
0025 methylpropanoate F
SH
MM0894.17-
4-Fluorothiophenol 371-42-6 100mg
0100 F
F F
H
MM0894.18- N
N-[4-Cyano-3-(trifluoromethyl)phenyl]-2-methylprop-2- F
90357-53-2 25mg O
0025 enamide N
O O
MM0894.19- S
4-Fluorobenzenesulfonic Acid 368-88-7 100mg OH
0100
F
F
F F
MM0894.20- H2 N
4-Amino-3-(trifluoromethyl)benzonitrile 327-74-2 25mg
0025
N
F
F
O F
H
MM0894.21- N-[4-Cyano-2-(trifluoromethyl)phenyl]-2-methyloxirane-2- N
1375105-27-3 25mg
0025 carboxamide O
N
MM0894.22- O O O F F
H
S N
O-Acetylbicalutamide 1375105-24-0 25mg F
O
0025 F
N
OH F F
H
MM0894.31- N-[4-Cyano-3-(trifluoromethyl)phenyl]-2,3-dihydroxy-2- HO N
F
316373-92-9 25mg O
0025 methylpropanamide N
OH F F
H
MM0894.32- 3-Chloro-N-[4-cyano-3-(trifluoromethyl)phenyl]-2-hydroxy-2- Cl N
F
627484-44-0 25mg O
0025 methylpropanamide N
Bictegravir Sodium
H O O
MM3948.00- O F F
H
N
H
N
Na
+
0250 O F
F F
MM3948.03- H2 N
2,4,6-Trifluorobenzylamine 214759-21-4 100mg
0100
F
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-74
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
Bifonazole
H
N
MM0015.02 Impurity C (EP): 1H-Imidazole (Imidazole) 288-32-4 100mg
N
Cl
MM0318.03 66600-13-3 100mg
4-yl)phenylmethyl]-1H-imidazolium Chloride N
Cl
66600-13-3 25mg
0025 4-yl)phenylmethyl]-1H-imidazolium Chloride N
Bilastine
OH
O
MM3614.00- O
0250 N
MM3614.01- 1-(2-Ethoxyethyl)-2-(4-piperidinyl)-1H-benzimidazole NH
HCl
n/a 25mg N
0025 Hydrochloride N
Bimatoprost
O
N
H
HO
O
H
MM3603.01- [(3aR,4R,5R,6aS)-4-Formyl-2-oxo-3,3a,4,5,6,6a- H
38754-71-1 25mg O
0025 hexahydrocyclopenta[b]furan-5-yl] 4-Phenylbenzoate O
O
[(3aR,4R,5R,6aS)-4-[(E,3S)-3-Hydroxy-5-phenylpent-1-enyl]- O
MM3316.05- H H
0025 O
Phenylbenzoate
Biperiden Hydrochloride
AND Enantiomer
OH
MM0288.00 Biperiden Hydrochloride 1235-82-1 250mg H H
N HCl
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-75
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
AND Enantiomer
OH O
H H
+
MM0288.07 Biperiden N-Oxide n/a 100mg N
AND Enantiomer
MM0288.08- H H
OH O
+
Biperiden Epoxide N-Oxide n/a 25mg N
0025 O
H
Bisacodyl
O O
O O
diphenol
MM0031.01
Related compound A (USP): 4,4'-(Pyridin-2-ylmethylene)
603-41-8 100mg N
diphenol
Impurity A (EP): 4,4'-(Pyridin-2-ylmethylene)- HO OH
MM0031.01- diphenol
Related compound A (USP): 4,4'-(Pyridin-2-ylmethylene)
603-41-8 25mg N
0025
diphenol
OH
Impurity B (EP): 2-[(RS)-(4-Hydroxyphenyl)-
MM0031.04- (pyridin-2-yl)methyl]phenol
Related compound B (USP): 2,4'-(Pyridin-2-ylmethylene)
16985-05-0 25mg OH
0025 N
diphenol
Impurity C (EP): 4-[(RS)-(4-Hydroxyphenyl)- HO O
(pyridin-2-yl)methyl]phenyl Acetate O
MM0031.02
Related compound C (USP): 4-[(4-Hydroxyphenyl)(pyridin-
72901-16-7 100mg N
2-yl)methyl]phenyl acetate
Impurity C (EP): 4-[(RS)-(4-Hydroxyphenyl)- HO O
(pyridin-2-yl)methyl]phenyl Acetate O
MM0031.03
Related compound E (USP): 2-[(4-Acetoxyphenyl)(pyridin-2-
111664-35-8 50mg
N
yl)methyl]phenyl acetate
4-[(RS)-(4-Hydroxyphenyl)(pyridin-2-yl)- HO O
S
O Na
+
MM0054.01
(4-[(Pyridin-2-yl)(4-hydroxyphenyl)methyl]-
32500-19-9 100mg N
(4-[(Pyridin-2-yl)(4-hydroxyphenyl)methyl]-
32500-19-9 25mg N
0025
phenyl Sodium Sulphate)
2-[(RS)-(Pyridin-2-yl)[4-(sulphonatooxy)- Na
+O
S
O
n/a 25mg
0025 (2,4'-[(Pyridin-2-yl)methylene]bisphenyl N
O
O O
S
O
Bis(Sodium Sulphate))
Bis(2-ethylhexyl) Maleate
Bisoctrizole
N OH OH N
N N
N N
MM3255.00-
Bisoctrizole 103597-45-1 250mg
0250
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-76
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
HO
N
2-(2H-Benzotriazol-2-yl)-4-(1,1,3,3-tetramethylbutyl)phenol N
N
MM3255.01 Related compound A (USP): 2-(2H-Benzotriazol-2-yl)-4- 3147-75-9 100mg
(1,1,3,3-tetramethylbutyl) phenol
HO
N
2-(2H-Benzotriazol-2-yl)-4-(1,1,3,3-tetramethylbutyl)phenol N
MM3255.01- N
Related compound A (USP): 2-(2H-Benzotriazol-2-yl)-4- 3147-75-9 25mg
0025
(1,1,3,3-tetramethylbutyl) phenol
Bisoprolol Fumarate
OH
H
O N
OH OH
H
O N O
MM0460.08-
Bisoprolol Fumarate 104344-23-2 250mg O
O
0250 O HO
2
OH
H
Impurity A (EP): (RS)-1-(4-Hydroxymethyl- O N
OH
H
MM0460.01- Impurity A (EP): (RS)-1-(4-Hydroxymethyl- O N
62572-93-4 25mg
0025 phenoxy)-3-isopropylaminopropan-2-ol OH
OH
H
O N
Impurity B (EP): (RS)-1-Isopropylamino-3-[4-(2-
MM0460.07 1447715-44-7 100mg
propoxyethoxymethyl)phenoxy]propan-2-ol O
O
3-isopropylaminopropoxy)benzyl]-
N O O N
3-isopropylaminopropoxy)benzyl]-
N O O N
1225195-70-9 25mg
0025 phenoxy]-3-isopropylaminopropan-2-ol
isopropylaminopropoxy)benzyloxymethyl]phenoxy]-3-
N O O N
1225195-71-0 25mg O
0025 isopropylaminopropan-2-ol
O
H
Impurity E (EP): EZ-[3-[4-(2-Isopropoxyethoxy- N
methoxy]methylphenoxy)-3-(isopropylamino)propan-2-ol
OH
1346601-19-1 25mg O
0025 2-Hydroxy-3-(isopropylamino)propyl)oxy]benzoate O
MM0460.23- (2RS)-1-[4-((2-Hydroxy-ethoxy)methyl)phenoxy]- HO
O
OH
H
N
109791-18-6 25mg
0025 3-(isopropylamino)-2-propanol O
O
0025 benzoate (Bisoprolol Ester)
Impurity L (EP) as Hydrochloride: 4-[[(2RS)-2--
HCl OH
(isopropylamino)propyl]oxy]benz-Hydrochloride (4-[(2RS)-2- O
H
N
MM0027.24 1956321-87-1 100mg
Hydroxy- O
-[(1-methylethyl)amino]propoxy]benzaldehyde)
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-77
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
-[(1-methylethyl)amino]propoxy]benzaldehyde)
Impurity M (Pharmeuropa): 4-[(2-Isopropoxy- O
OH
MM0460.02 177034-57-0 100mg
ethoxy)methyl]phenol O
n/a 25mg
0025 methyl]phenoxy]-3-isopropylaminopropan-2-ol O
OH
H
(2RS)-4-[2-Hydroxy-3-(isopropylamino)propoxy]- O N
MM0460.27 HO
benzoic Acid Hydrochloride
33948-04-8 50mg
O HCl
OH
MM0460.28- Impurity R (EP): (2RS)-1-(Isopropylamino)-3-(4- O
H
N
5790-46-5 25mg
0025 methylphenoxy)propan-2-ol
OH
OH
MM0460.14-
Impurity S (EP): 4-Hydroxybenzaldehyde 123-08-0 25mg
0025
O
O
O
O
2-[4-(2-Isopropoxyethoxymethyl)-
phenoxymethyl]oxirane
MM0460.03 66722-57-4 100mg
O
O
OH
OH
MM0460.06-
4-Hydroxybenzyl Alcohol 623-05-2 25mg HO
0025
O
MM0460.10- HO
Fumaric Acid 110-17-8 250mg OH
0250 O
HO
O
MM0460.13- N
iso-Bisoprolol n/a 25mg H
0025
O
O
OH
H
O N
MM0460.29- Isopropyl 4-(2-Hydroxy-3-isopropylpropoxy)- O
benzoate Hydrochloride
n/a 25mg
O
0025 HCl
O
OH
O N
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-78
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
O
OH
O N
O
O
O
MM0460.33- O N
N,O-Diacetylbisoprolol n/a 25mg
0025
O
O
O
N
MM0460.34- 5-[[4-[[2-(1-Methylethoxy)ethoxy]methyl]phenoxy]methyl]-3- O
87844-84-6 25mg
0025 (1-methylethyl)-2-oxazolidinone
O
O
O
MM0460.35- HO OH
(E)-4-(Carboxymethoxy)-4-oxobut-2-enoic Acid 2169861-24-7 25mg O
0025 O O
OH OH
MM0460.36- O N O
1,1'-[(1-Methylethyl)imino]bis(1-(4-((2-isopropoxyethoxy)
n/a 100mg
O O
0100 methyl)phenoxy)propan-2-ol O O
O
MM0460.37- O
[[4-(Hydroxymethyl)phenoxy]methyl]oxirane 4204-78-8 25mg HO
0025
OH
H
O N O
MM0460.38- N-[2-Hydroxy-3-[4-(2-isopropoxyethoxymethyl)phenoxy]
1346602-59-2 25mg
0025 propyl]formamide (N-Desisopropyl-N-formyl Bisoprolol) O
O
Bitoscanate
N
C
MM1837.00 Bitoscanate 4044-65-9 250mg S
C
S
N
Boldenone
OH
H
MM0864.00 Boldenone 846-48-0 100mg
H H
O
Boldenone Cypionate
O
O
MM3718.00-
Boldenone Cypionate 106505-90-2 100mg H
H H
0100 O
Boldenone Undecylenate
O
H
O
Bortezomib
N-[(1S)-2-Amino-1-benzyl-2-oxoethyl]pyrazine-2- O
MM3368.02 289472-80-6 100mg N NH2
carboxamide N
H
O
N
MM3368.02- N-[(1S)-2-Amino-1-benzyl-2-oxoethyl]pyrazine-2- O
289472-80-6 25mg N NH2
0025 carboxamide N
H
O
N
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-79
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
( S)- -Amino-N-[(1R)-1-[(3aS,4S,6S,7aR)-hexahydro-3a,5,5- H
MM3368.04- trimethyl-4,6-methano-1,3,2-benzodioxaborol-2-yl]-3- H
N
O
B
O
H
HCl
H 2N H
MM3368.07- (2S)-3-Phenyl-2-[[(pyrazin-2-yl)carbonyl]amino]propanoic O
114457-94-2 25mg N OH
0025 Acid N
H
O
N
Bosentan Monohydrate
O O
S
NH O
O
N
OH
4-tert-Butyl-N-[6-chloro-5-(2-methoxyphenoxy)-2,2'-
O O
S
bipyrimidin-4-yl]benzenesulfonamide NH O
MM3369.01- O
N
Related compound A (USP): 4-(tert-butyl)-N-[6-chloro-5-(2- 150727-06-3 25mg N
0025 N Cl
methoxyphenoxy)-(2,2'-bipyrimidin)-4-yl] N
benzenesulfonamide
O O
4-(tert-Butyl)benzenesulfonamide S
NH2
MM3369.02 Related compound E (USP): 4-(tert-butyl) 6292-59-7 100mg
benzenesulfonamide
O O
4-(tert-Butyl)benzenesulfonamide S
MM3369.02- NH2
Related compound E (USP): 4-(tert-butyl) 6292-59-7 25mg
0025
benzenesulfonamide
Cl O
4,6-Dichloro-5-(2-methoxyphenoxy)-2,2'-bipyrimidine O
N
MM3369.03 Related compound D (USP): 4,6-dichloro-5-(2- 150728-13-5 100mg N
N Cl
methoxyphenoxy)-2,2'-bipyrimidine N
Cl O
4,6-Dichloro-5-(2-methoxyphenoxy)-2,2'-bipyrimidine O
MM3369.03- N
Related compound D (USP): 4,6-dichloro-5-(2- 150728-13-5 25mg N
N Cl
0025
methoxyphenoxy)-2,2'-bipyrimidine N
OH O
O
4,6-Dihydroxy-5-(2-methoxyphenoxy)-2-(pyrimidin-2-yl) N
MM3369.04 329923-15-1 100mg N
pyrimidine N OH
N
OH O
O
MM3369.04- 4,6-Dihydroxy-5-(2-methoxyphenoxy)-2-(pyrimidin-2-yl) N
329923-15-1 25mg N
N OH
0025 pyrimidine
N
Brexpiprazole
H
O N O
N
NH
N
HCl
MM3702.01 1-Benzo[b]thien-4-yl-piperazine Hydrochloride 913614-18-3 100mg
S
NH
MM3702.01- N
HCl
1-Benzo[b]thien-4-yl-piperazine Hydrochloride 913614-18-3 25mg
0025
S
Brimonidine Tartrate
N OH O
MM1324.00-
Brimonidine Tartrate
N Br HO
HN OH
70359-46-5 250mg N N
O OH
0250 H
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-80
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
N
MM1324.01- Impurity A (EP): N-(Imidazolidin-2-ylidene)quinoxalin-6- N
HN
91147-43-2 25mg
0025 amine N
N
H
N
MM1324.02- Impurity B (EP): 5-Bromoquinoxalin-6-amine N Br
Related compound A (USP): 5-Bromoquinoxalin-6-amine
50358-63-9 25mg
0025
NH2
N
N
MM1324.03 Impurity C (EP): Quinoxalin-6-amine 6298-37-9 100mg
NH2
N
MM1324.03- N
Impurity C (EP): Quinoxalin-6-amine 6298-37-9 25mg
0025
NH2
N
Impurity D (EP): 1-(5-Bromoquinoxalin-6-yl)thiourea N Br
MM1324.04-
Related compound B (USP): 1-(5-Bromoquinoxalin-6-yl) 842138-74-3 25mg S
0025 thiourea N
H
NH2
N
MM1324.10- N Br
S
1-(2-Aminoethyl)-3-(5-bromoquinoxalin-6-yl)thiourea 134892-47-0 25mg NH2
0025 N N
H H
MM1324.13- N Cl
N
5-Chloro-N-(4,5-dihydro-1H-imidazol-2-yl)quinoxalin-6-amine 91147-46-5 25mg
0025 N N
H H
Brinzolamide
O O
O S S
O N O
S
HN
O O
O S S
MM1300.03- (4S)-3,4-Dihydro-4-hydroxy-2-(3-methoxypropyl)-2H-thieno O N O
S
154127-42-1 25mg H2 N
0025 [3,2-e]-1,2-thiazine-6-sulfonamide 1,1-Dioxide OH
O O
O S S
O N O
(4R)-4-(Isopropylamino)-2-(3-methoxypropyl)-3,4-dihydro-2H- S
H 2N
MM1300.05 n/a 100mg HN
thieno[3,2-e]-1,2-thiazine-6-sulfonamide 1,1-Dioxide
O O
O S S
O N O
MM1300.05- (4R)-4-(Isopropylamino)-2-(3-methoxypropyl)-3,4-dihydro-2H- S
H 2N
n/a 25mg HN
0025 thieno[3,2-e]-1,2-thiazine-6-sulfonamide 1,1-Dioxide
O O
(4R)-4-(Ethylamino)-2-(3-methoxypropyl)-3,4-dihydro-2H- O S S
O N O
S
HN
MM1300.06 thieno[3,2-e]-1,2-thiazine-6-(N-methylsulfonyl)sulfonamide n/a 100mg S
HN
O
O
1,1-Dioxide (Brinzolamide Methanesulfonimide Analogue)
O O
(4R)-4-(Ethylamino)-2-(3-methoxypropyl)-3,4-dihydro-2H- O S S
O N O
MM1300.06- S
HN
thieno[3,2-e]-1,2-thiazine-6-(N-methylsulfonyl)sulfonamide n/a 25mg S
HN
0025 O
O
1,1-Dioxide (Brinzolamide Methanesulfonimide Analogue)
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-81
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
Brivaracetam
O
H 2N
MM3939.00- N
Brivaracetam 357336-20-0 250mg O
0250
Bromazepam
H O
N
Br N
MM0064.00 Bromazepam 1812-30-2 CS 100mg
N
NH2
O
Impurity A (EP): (2-Amino-5-bromophenyl)- Br
MM0064.01 1563-56-0 100mg
(pyridin-2-yl)methanone N
NH2
O
MM0064.01- Impurity A (EP): (2-Amino-5-bromophenyl)- Br
1563-56-0 25mg
0025 (pyridin-2-yl)methanone N
O
Cl
NH
H O
N
H
N O
O
Br
NH
Bromazine Hydrochloride
MM0640.02-
4-Bromo- -phenylbenzenemethanol (4-Bromobenzhydrol) 29334-16-5 25mg
0025 OH
Br
OH
N
MM1681.02 Deanol (2-(Dimethylamino)ethanol) 108-01-0 100mg
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-82
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
2
Na
+
2
H2 O
3
O N H2
MM3532.01- O
Bromfenac Methyl Ester n/a 25mg O
0025 Br
O N H2
MM3532.02- O
Bromfenac Ethyl Ester 102414-22-2 25mg O
0025 Br
O N H2
MM3532.03- O
Bromfenac Isopropyl Ester n/a 25mg O
0025 Br
O
H
O N
O
H
O N
MM3532.08-
7-(4-Bromobenzoyl)indolin-2-one (Bromfenac Lactam) 91713-91-6 25mg
0025
Br
Bromhexine Hydrochloride
Br
MM0065.00-
Bromhexine Hydrochloride 611-75-6 250mg Br
N
HCl
0250 NH2
Br
OH
Impurity A (EP): (2-Amino-3,5-
MM0005.01 50739-76-9 100mg
dibromophenyl)methanol NH2
Br
Br
OH
MM0005.01- Impurity A (EP): (2-Amino-3,5-
50739-76-9 25mg
0025 dibromophenyl)methanol NH2
Br
Br
O
Impurity B (EP): 2-Amino-3,5-
MM0005.02 50910-55-9 100mg
dibromobenzaldehyde NH2
Br
Br
O
MM0005.02- Impurity B (EP): 2-Amino-3,5-
50910-55-9 25mg
0025 dibromobenzaldehyde NH2
Br
Br
Impurity D (EP) as Dihydrochloride: N-(2-
MM0065.03 Amino-5-bromobenzyl)-N-methyl- 10076-98-9 100mg N HCl
2
Br
Br
tetrahydroquinazolin-3-ium Chloride HN N
+
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-83
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
Br
N-(2-Nitrobenzyl)-N-cyclohexyl-N- N
methylamine
MM0065.01 80638-08-0 100mg +
N
O O
MM0065.01- N-(2-Nitrobenzyl)-N-cyclohexyl-N- N
methylamine
80638-08-0 25mg +
0025 N
O O
Br
6,8-Dibromo-3-cyclohexyl-3,4- Br
MM0065.05
dihydro-2(1H)-quinazolinone
21237-84-3 100mg
HN N
Br
MM0065.05- 6,8-Dibromo-3-cyclohexyl-3,4- Br
dihydro-2(1H)-quinazolinone
21237-84-3 25mg
0025 HN N
Br
O
NH2
Br
[[cyclohexyl(methyl)amino]methyl]phenyl]-4-oxo-pentanamide HN O
n/a 25mg
0025
Hydrochloride) O
Bromisoval
O
Bromocriptine Mesilate
Br H
N O
H O
HN N N
O O
S
OH
Brompheniramine Maleate
O
N
OH
MM0060.00 Brompheniramine Maleate 980-71-2 500mg N
OH
O
Br
Cl
O
MM0090.00- Impurity A (EP) as Maleate: Chlorphenamine OH
113-92-8 250mg
0250 Maleate N
N
OH
Cl
O
N
N
Impurity C (EP): (3RS)-N,N-Dimethyl-3-phenyl-
MM0059.01 86-21-5 100mg
3-(pyridin-2-yl)propan-1-amine (Pheniramine)
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-84
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
OH
3-phenyl-3-(pyridin-2-yl)propan-1-amine 132-20-7 250mg OH
MM1439.00- OH
Maleic Acid 110-16-7 250mg
0250 OH
H
N N N
MM0090.04 2,2'-Dipyridylamine 1202-34-2 100mg
H
N N N
MM0090.04-
2,2'-Dipyridylamine 1202-34-2 25mg
0025
N
HCl
MM0060.18 Brompheniramine N-Oxide Dihydrochloride n/a 100mg N
+
O
2
Br
OH
N
MM0060.19- O
Brompheniramine N-Oxide Maleate n/a 100mg +
N O
O
0100 Br OH
O
N
OH
MM0060.16 Desmethylbrompheniramine Maleate n/a 100mg N
H
OH
O
Br
O
N
MM0060.16- OH
Desmethylbrompheniramine Maleate n/a 25mg N
H
OH
0025 Br
O
Brotizolam
Br
Broxyquinoline
OH
Br N
Br
Brucine
H N
O
H H
MM1714.00 Brucine 357-57-3 100mg O N
H
O O
H
Buclizine Hydrochloride
Cl
N
N
(1,4-Bis[(4-chlorophenyl)phenylmethyl]piperazine) Cl
346451-15-8 25mg N
0025 (1,4-Bis[(4-chlorophenyl)phenylmethyl]piperazine) Cl
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-85
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
Cl
MM0380.09-
4-Chlorobenzhydrol 119-56-2 25mg
0025 OH
Cl
Cl
MM0380.10-
4-Chlorobenzophenone 134-85-0 25mg
0025 O
Cl
Cl
NH
1-(4-Chlorobenzhydryl)piperazine N
Cl
NH
MM0380.01- 1-(4-Chlorobenzhydryl)piperazine N
Budesonide
OH
O
MM0204.00- HO O
0250 H H
O
OH
O
Impurity A (EP): 11 ,16 ,17,21-Tetrahydroxy- HO OH
prednisolone) O
H H
OH
O
0025
prednisolone) O
H H
OH
O
O OH
Impurity C (EP): 16 ,17-[(1RS)-Butylidenebis(oxy)]-11 - HO O
MM0204.03- H
hydroxy-17-(hydroxymethyl)-D-homo-androsta-1,4-diene- 1040085-99-1 25mg O
H H H
0025 O
3,17a-dione
OH
O
MM0204.06- HO O
Impurity F (EP): 16a,17-[1-Methylethylidenebis(oxy)]-11ß,21- H O
638-94-8 25mg
0025 dihydroxypregna-1,4-diene-3,20-dione (Desonide) H H
O
MM0204.07- 11 ,21-dihydroxypregn-4-ene-3,20-dione HO O
H H
Related compound G (USP): 16alpha,17-[butylidenebis
0025
O
(oxy)]-11beta, 21-dihydroxypregna-4-ene-3,20-dione
OH
O
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-86
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
OH
O
OH
O
O
O
MM0204.15- Impurity K (EP): 16 ,17-[(1RS)-Butylidenebis(oxy)]-11 ,21- HO O
51333-05-2 25mg H O
0025 dihydroxypregna-1,4-diene-3,20-dione-21-acetate H H
O
MM0204.16- 21-hydroxypregna-1,4-diene-3,11,20-trione O
H
O
O
216453-74-6 25mg
0025 Related compound L (USP): 16alpha,17-[butylidenebis H H
O
(oxy)]-21-hydroxypregna-1,4-diene-3,11,20-trione
O
OH
HO O
MM0204.08-
Budesonide 20-Carboxylic Acid 192057-49-1 25mg H O
0025 H H
O
O O
HO
MM0204.10- 11 ,16 -Dihydroxyandrosta-1,4-diene-3,17-dione H O
85234-64-6 25mg
0025 16-Butyrate O
H H
O
O
MM0204.18- HO O
Budesonide 21-Butanoate 2408495-96-3 25mg H O
0025 H H
O
Bufexamac
H
N
OH
OH
MM0179.01-
Impurity A (EP): 2-(4-Butoxyphenyl)acetic Acid 4547-57-3 25mg O
O
0025
acetate O
NH2
NH2
MM0179.04-
Impurity D (EP): 2-(4-Butoxyphenyl)acetamide 3413-59-0 25mg O
O
0025
Buflomedil Hydrochloride
O O
O O HCl
(o-Desmethyl-Buflomedil Hydrochloride)
Impurity B (EP) as Hydrochloride: 4-(Pyrrolidin-
O O
1-yl)-1-(4-hydroxy-2,6-dimethoxyphenyl)- N
MM0066.02 70585-59-0 100mg
butan-1-one Hydrochloride HO O
HCl
(p-Desmethyl-Buflomedil Hydrochloride)
Impurity B (EP) as Hydrochloride: 4-(Pyrrolidin-
O O
MM0066.02- 1-yl)-1-(4-hydroxy-2,6-dimethoxyphenyl)- N
70585-59-0 25mg
0025 butan-1-one Hydrochloride HO O
HCl
(p-Desmethyl-Buflomedil Hydrochloride)
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-87
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
O
MM0066.05-
1,3,5-Trimethoxybenzene 621-23-8 25mg
0025
O O
Cl
Cl
MM0066.06-
1-Chloro-3,5-dimethoxybenzene 7051-16-3 25mg
0025
O O
Br
Br
MM0066.09-
1-Bromo-3,5-dimethoxybenzene 20469-65-2 25mg
0025
O O
Br
Br
MM0066.10-
1,3,5-Tribromobenzene 626-39-1 25mg
0025
Br Br
O O
O
MM0066.12- N
+
HCl
Buflomedil N-Oxide Hydrochloride n/a 25mg
0025 O O
Buformin Hydrochloride
NH NH HCl
Bumetanide
O O O
S
H2 N OH
MM1290.00-
Bumetanide 28395-03-1 250mg O
0250 HN
O O O
Impurity A (EP): 3-Nitro-4-phenoxy-5-sulphamoylbenzoic H2 N
S
OH
MM1290.01 Acid O
28328-53-2 100mg
Related compound B (USP): 3-Nitro-4-phenoxy-5- O
N
+
O
sulfamoylbenzoic Acid
O O O
Impurity A (EP): 3-Nitro-4-phenoxy-5-sulphamoylbenzoic H2 N
S
OH
MM1290.01- Acid O
28328-53-2 25mg
0025 Related compound B (USP): 3-Nitro-4-phenoxy-5- O
N
+
O
sulfamoylbenzoic Acid
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-88
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
O O O
sulfamoylbenzoic Acid
O O O
S
H2 N O
Impurity C (EP): Butyl 3-(Butylamino)-4-phenoxy-5- O
MM1290.03 32643-00-8 100mg
sulfamoylbenzoate HN
O O O
S
H2 N O
MM1290.03- Impurity C (EP): Butyl 3-(Butylamino)-4-phenoxy-5- O
32643-00-8 25mg
0025 sulfamoylbenzoate HN
Bunolol Hydrochloride
OH
H
Buparvaquone
O
Buphenine Hydrochloride
OH
Bupivacaine Hydrochloride
MM0613.00- H
N HCl H2 O
N
Bupivacaine Hydrochloride Monohydrate 73360-54-0 250mg O
0250
H
Impurity A (EP): N-(2,6-Dimethylphenyl)pyridine- N
MM0368.03 39627-98-0 100mg N
2-carboxamide O
H
MM0368.03- Impurity A (EP): N-(2,6-Dimethylphenyl)pyridine- N
39627-98-0 25mg N
0025 2-carboxamide O
2-carboxamide
Impurity B (EP): (2RS)-N-(2,6-Dimethylphenyl)piperidine-2-
H
MM0368.08- carboxamide 15883-20-2 25mg N
N
0025 Related compound B (USP): N-(2,6-dimethylphenyl)piperidine- O
H
2-carboxamide
Cl
Impurity D (EP): (2RS)-2,6-Dichloro-N-(2,6- H
N
Cl
MM0613.04 1037184-07-8 50mg
dimethylphenyl)hexanamide O
N
H
Related compound A (USP): 6-(butylamino)-N-(2,6-
2518187-63-6 25mg O
0025
dimethylphenyl)hexanamide
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-89
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
N H2
MM0102.02 Impurity F (EP): 2,6-Dimethylaniline 87-62-7 100mg
O
O
Buprenorphine
N
MM0120.00- OH
Buprenorphine 52485-79-7 CS 250mg
0250 H
HO O O
H
N
Impurity B (EP): (2S)-2-(4,5 -Epoxy-3-hydroxy-6-methoxy-
MM0120.10- OH
6 ,14-ethano-14 -morphinan-7 -yl)-3,3-dimethylbutan-2-ol 78715-23-8 25mg
0025 H
(Norbuprenorphine) HO O O
17-carbonitrile)
Impurity E (EP): (2S)-2-[17-(Cyclopropylmethyl)-4,5 -epoxy- N
OH
MM0120.15 Buprenorphine N-Oxide 112242-17-8 100mg
H
HO O O
O +
N
MM0120.15- OH
Buprenorphine N-Oxide 112242-17-8 25mg
0025 H
HO O O
Buprenorphine Hydrochloride
N HCl
OH
MM1237.00 Buprenorphine Hydrochloride 53152-21-9 CS 250mg
H
HO O O
H
N
Impurity B (EP): (2S)-2-(4,5 -Epoxy-3-hydroxy-6-methoxy-
MM0120.10- OH
6 ,14-ethano-14 -morphinan-7 -yl)-3,3-dimethylbutan-2-ol 78715-23-8 25mg
0025 H
(Norbuprenorphine) HO O O
17-carbonitrile)
Impurity E (EP): (2S)-2-[17-(Cyclopropylmethyl)-4,5 -epoxy- N
OH
MM0120.15 Buprenorphine N-Oxide 112242-17-8 100mg
H
HO O O
O +
N
MM0120.15- OH
Buprenorphine N-Oxide 112242-17-8 25mg
0025 H
HO O O
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-90
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
Bupropion Hydrochloride
O
H
Cl N
MM0745.00 Bupropion Hydrochloride 31677-93-7 100mg HCl
2-(tert-Butylamino)-4'-chloropropiophenone
O
Hydrochloride H
N
HCl
chloropropiophenone
2-(tert-Butylamino)-4'-chloropropiophenone
O
MM0745.02- Hydrochloride H
N
HCl
chloropropiophenone
2-(tert-Butylamino)-3'-bromopropiophenone
O
Hydrochloride Br
H
N
HCl
Hydrochloride
MM0745.05 63199-74-6 100mg
O
MM0745.05- 2-(tert-Butylamino)propiophenone H
N
HCl
63199-74-6 25mg
0025 Hydrochloride
O
Cl O
MM0745.06 1-(3-Chlorophenyl)-1,2-propandione 10557-17-2 100mg
O
Cl
MM0745.08 3-Chloropropiophenone 34841-35-5 100mg
O
MM0745.08- Cl
3-Chloropropiophenone 34841-35-5 25mg
0025
AND Enantiomer
MM0745.14- O
Hydroxybupropion (as (RS,RS)-cyclic Hemiketal) 233600-52-7 25mg Cl
HO
NH
0025
O
2-Bromo-1-(3-chlorophenyl)propan-1-one (2-Bromo-3'- Cl Br
MM0745.15 chloropropiophenone) 34911-51-8 100mg
Related compound G (USP): 2-Bromo-1-(3-chlorophenyl)
O
MM0745.16- Cl
3-Chlorobenzoic Acid 535-80-8 25mg OH
0025
Buspirone Hydrochloride
O
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-91
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
+
MM0464.05- Impurity B (EP) as Bromide: 8-(Pyrimidin-2-yl)- N
N N Br
81461-73-6 25mg
0025 8-aza-5-azoniaspiro[4.5]decane Bromide N
N
N
O
N
N N
MM0464.20- [1-[2-Oxo-2-[[4-[4-(pyrimidin- O
O
HN
N
N
N N
O OH
n/a 25mg
-yl)piperazin-1-yl]butyl]amino]ethyl]cyclopentyl]-
O OH
N N N 2
0025 N
acetate Dioxalate
N
Impurity G (EP): 2,2'-(Piperazine-1,4-diyl)dipyrimidine
N N
MM0464.12 Related compound G (USP): 1,4-Di(pyrimidin-2-yl) 84746-24-7 50mg N N
piperazine N
O OH
N
N
N
O OH
2
0025 7,9-dione N
Cl
[1-[2-Oxo-2- O
O
O
O
N
N
N
amino]ethyl]cyclopentyl]acetate Oxalate O OH
O
Impurity K (EP): 8-Azaspiro[4,5]decane-7,9-dione
MM0464.08 Related compound K (USP): 8-azaspiro[4.5]decane-7,9- 1075-89-4 100mg NH
dione
O
O
Impurity K (EP): 8-Azaspiro[4,5]decane-7,9-dione
MM0464.08-
Related compound K (USP): 8-azaspiro[4.5]decane-7,9- 1075-89-4 25mg NH
0025 dione
O
[4.5]decane-7,9-dione) N
N
O
azaspiro[4.5]decane-7,9-dione
HO
N
MM0464.17- N N
4-[4-(Pyrimidin-2-yl)piperazin-1-yl]butanol Hydrochloride n/a 25mg HCl
0025 N
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-92
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
O
O
OH
O HO
MM0464.31- N
N
+ O
Buspirone N-Oxide Oxalate 1797880-63-7 25mg O N N
0025 N
O
O
MM0464.25 7,9-Dioxo-8-azaspiro[4.5]decane-8-butanoic Acid 105920-65-8 100mg N
OH
O
O
MM0464.25- O
7,9-Dioxo-8-azaspiro[4.5]decane-8-butanoic Acid 105920-65-8 25mg N
OH
0025 O
Busulfan
O O
O
S
O
Butacaine Sulfate
O
O O
O
MM1638.01- O
+
O N
Butacaine N-Oxide n/a 25mg H 2N
0025
O
MM1638.02- O
+ HCl
O N
Butacaine N-Oxide Hydrochloride n/a 25mg H 2N
0025
Butafosfan
O
H H
MM3311.00 Butafosfan 17316-67-5 250mg N P
OH
Butalamine Hydrochloride
H
N O
N
N
O H
+ N O
N
MM1845.02- N
N
Butalamine N-Oxide n/a 25mg
0025
Butalbital
H
O N O
MM0774.00-
Butalbital 77-26-9 CS 250mg NH
0250
O
H
O N O
Butamben
O
H 2N
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-93
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
Butamirate Citrate
O
OH
O O
O
OH
OH
O
MM0606.00 Butetamate Citrate 13900-12-4 500mg O
N OH
OH
O
O
OH
MM1030.05 (2RS)-2-Phenylbutanoic Acid 90-27-7 100mg
O
MM1030.05- OH
(2RS)-2-Phenylbutanoic Acid 90-27-7 25mg
0025
O
O
MM3771.01- O
O N
2-[2-(Diethylamino)ethoxy]ethyl 2-Phenylacetate 47092-75-1 100mg
0100
O
O
MM3771.02-
N,N-Diethyl-2-phenylbutanamide 92321-53-4 25mg N
0025
MM3771.03- N
4-Ethylmorpholine 100-74-3 100mg
0100 O
Butobarbital
H
O N O
Butoconazole Nitrate
Cl
O
N
N
HO
N
+
Cl
MM1637.03- Cl S O HCl
Butoconazole Sulfoxide Hydrochloride n/a 25mg N
0025 Cl N
Cl
MM1637.02- O
Cl S
Butoconazole Sulfone n/a 25mg O
0025 N
Cl N
Butorphanol Tartrate
N OH O
O OH
OH
HO
O
+
N
HO
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-94
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
O
+
N
MM1192.01-
Butorphanol N-Oxide 112269-63-3 25mg HO
0025
HO
Butyl Parahydroxybenzoate
O
HO
O
MM0045.01-
Impurity A (EP): 4-Hydroxybenzoic Acid 99-96-7 250mg OH
0250
HO
O
MM0431.00- Impurity B (EP): Methyl 4-Hydroxybenzoate (Methyl O
99-76-3 250mg
0250 Parahydroxybenzoate)
HO
O
MM0498.00- Impurity C (EP): Ethyl 4-Hydroxybenzoate (Ethyl O
120-47-8 250mg
0250 Parahydroxybenzoate) HO
O
MM0432.00- Impurity D (EP): Propyl 4-Hydroxybenzoate O
94-13-3 250mg
0250 (Propyl Parahydroxybenzoate) HO
O
Impurity E (EP): 2-Methylpropyl 4-Hydroxybenzoate (Isobutyl O
MM0496.05 4247-02-3 100mg
Parahydroxybenzoate) HO
O
MM0496.05- Impurity E (EP): 2-Methylpropyl 4-Hydroxybenzoate (Isobutyl O
4247-02-3 25mg
0025 Parahydroxybenzoate) HO
Butylene Glycol
Butylhydroxyanisole
OH
OH
Butylhydroxytoluene
MM0679.00- OH
Butylhydroxytoluene 128-37-0 250mg
0250
MM0679.01- OH
2,6-Di-tert-butyl-4-hydroxymethylphenol 88-26-6 25mg
0025 HO
Cabazitaxel
O O O
O
O
O
MM3517.00- N
H
Cabazitaxel
H O
H O
HO O
183133-96-2 250mg O OH O
0250 O
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-95
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
Cabozantinib L-Malate
N O
O
MM3947.00- O
O
F
HO
OH
O O
Cabozantinib (S)-Malate 1140909-48-3 250mg N N
O OH
H H
0250
Caffeine
O
N
MM0494.00- N
Caffeine 58-08-2 250mg
0250
O N N
O
H
N N
MM0176.00 Impurity A (EP): Theophylline 58-55-9 500mg
O N N
O
H
Impurity B (EP): N-(6-Amino-1,3-dimethyl- N
N
O
H
MM0176.02- Impurity B (EP): N-(6-Amino-1,3-dimethyl- N
N
N
Impurity C (EP): 1,3,9-Trimethyl-3,9-dihydro- N
MM0494.03 519-32-4 50mg
1H-purine-2,6-dione (Isocaffeine) N
O N
HN N
MM0577.00 Impurity D (EP): Theobromine 83-67-0 500mg
O N N
O
Impurity E (EP) as Nitrate: N,1-Dimethyl-4- N O
N +
MM0494.06 (methylamino)-1H-imidazole-5-carbox- 209725-34-8 100mg H
N
HO N
O
HN
amide Nitrate (Caffeidine Nitrate)
O
Impurity E (EP) as Nitrate: N,1-Dimethyl-4- N O
MM0494.06- N +
(methylamino)-1H-imidazole-5-carbox- 209725-34-8 25mg H
N
HO N
O
HN
0025 amide Nitrate (Caffeidine Nitrate)
O
Impurity F (EP): 1,7-Dimethyl-3,7-dihydro- N
N
MM0494.04 1H-purine-2,6-dione (Paraxanthine; 611-59-6 50mg
1,7-Dimethylxanthine) O N N
H
N
MM0599.08- 8-Chloro-1,3,7-trimethyl-3,7-dihydro-1H-purine-2,6-dione (8- N
4921-49-7 25mg Cl
0025 Chlorocaffeine) O N N
O
+
Na N
O
Sodium 4-[N-Methyl-N-(N-methylaminocarbonyl)amino]-1- N
N
methylimidazole-5-carboxylate
MM0494.10 n/a 50mg
HN O
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-96
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
Caffeine Citrate
O
O OH
O
N
N
OH
MM1851.00 Caffeine Citrate 69-22-7 250mg O N N OH
OH
O
Calcifediol Monohydrate
H
HO
HO
Calcitriol
OH
H
HO OH
3
O
H2 O
4
O
O
2
OH
2
HO
MM0632.01-
Impurity A (EP): Benzene-1,4-diol (Hydroquinone) 123-31-9 250mg
0250 OH
O
O
H 2N N N
H H
O OH
Impurity A (EP): (2S)-2-(4-Aminobenzamido)pentanedioic O
MM0621.01- N
Acid ((2S)-2-[(4-Aminobenzoyl)amino]pentanedioic Acid; N- 4271-30-1 25mg H
OH
0025 H 2N
O
(4-Aminobenzoyl)-L-glutamic Acid)
MM0621.01- N
Acid ((2S)-2-[(4-Aminobenzoyl)amino]pentanedioic Acid; N- 4271-30-1 25mg H
OH
0025 H 2N
O
(4-Aminobenzoyl)-L-glutamic Acid)
MM0881.00-
Orotic Acid 65-86-1 250mg NH
0250
O OH
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-97
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
Calcium Pantothenate
O O
Calcium Pantothenate HO 2+
Ca
N O
MM1499.00 137-08-6 250mg OH
H
2
O
MM1463.01 Impurity A (EP): 3-Aminopropanoic Acid ( -Alanine) 107-95-9 100mg
H 2N OH
O
HO
MM1352.03- Impurity C (EP): (3R)-3-Hydroxy-4,4-dimethyldihydrofuran-2
599-04-2 25mg O
0025 (3H)-one (Pantolactone)
O
HO
Impurity C (EP) as Racemate: (3RS)-3-Hydroxy-4,4-
MM1352.04 79-50-5 100mg O
dimethyldihydrofuran-2(3H)-one (D,L-Pantolactone)
O
HO
MM1352.04- Impurity C (EP) as Racemate: (3RS)-3-Hydroxy-4,4-
79-50-5 25mg O
0025 dimethyldihydrofuran-2(3H)-one (D,L-Pantolactone)
O O
Impurity D (EP): Methyl 3-[(2R)-2,4-Dihydroxy-3,3- HO
MM1499.01 50692-78-9 50mg N O
H
dimethylbutanamido]propanoate (Methyl Pantothenate) OH
O O
HO
N O
MM1499.02 Ethyl Pantothenate 10527-68-1 50mg OH
H
Camphor, Racemic
AND Enantiomer
O
MM0103.00 Camphor, Racemic 76-22-2 250mg
H
O
MM0103.01 rac-Norcamphor 497-38-1 100mg
O
MM0103.01-
rac-Norcamphor 497-38-1 25mg
0025
D-Camphor
O
MM3327.01-
L-Camphor 464-48-2 25mg
0025
H
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-98
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
Canadine
O
O
Candesartan Cilexetil
O O
O O O
MM0776.00- N N
Candesartan Cilexetil 145040-37-5 250mg N HN
N
N
0250 O
O
Impurity A (EP): Ethyl 2-Ethoxy-1-[[2'-(1H-tetrazol-5-yl) O
N N
MM0776.01- biphenyl-4-yl]methyl]-1H-benzimidazole-7-carboxylate HN N
N
139481-58-6 25mg N
0025 Related compound A (USP): Ethyl 1-[2'-(1H-tetrazol-5-yl) O
biphenyl-4-yl]methyl-2-ethoxybenzimidazole-7-carboxylate
Impurity B (EP): (1RS)-1-[[(Cyclohexyloxy)carbonyl]oxy]ethyl
O
2-Oxo-3-[[2'-(1H-tetrazol-5-yl)biphenyl-4-yl]methyl]-2,3- O O
O
MM0776.02- dihydro-1H-benzimidazole-4-carboxylate O
N N
869631-11-8 25mg HN N
0025 Related compound B (USP): 1-(Cyclohexyloxycarbonyloxy) N
N
ethyl 1-[2'-(1H- tetrazol-5-yl)biphenyl-4-yl]methyl-2-oxo-2,3- H O
dihydrobenzimidazole-7-carboxylate
O
O
O
O
N N
3-[[2'-(1-Ethyl-1H-tetrazol-5-yl)biphenyl-4-yl]methyl]-2-oxo- 1185255-99-5 25mg N
N N
0025 2,3-dihydro-1H-benzimidazole-4-carboxylate N
H O
O
MM0776.04- 2,3-dihydro-1H-benzimidazole-4-carboxylate O
O
N N
1185256-03-4 25mg N N
0025 Related compound D (USP): 1-[(Cyclohexyloxy)carbonyl] N
N
oxyethyl 3-(2'-(2-ethyl-2H-tetrazol-5-yl)-[1,1'-biphenyl]-4- H O
ylmethyl)-2-oxo-2,3-dihydro-1H-benzimidazole-4-carboxylate
O
O
O
O
N N
2-Ethoxy-1-[[2'-(1-ethyl-1H-tetrazol-5-yl)biphenyl-4-yl]methyl]- 914613-35-7 25mg N
N N
0025 1H-benzimidazole-7-carboxylate N
O
O
O
MM0776.06- methyl]-1H-benzimidazole-7-carboxylate O
N N
914613-36-8 25mg N N
ethyl 2-ethoxy-1-[2'-(2-ethyl-2H-tetrazol-5-yl)biphenyl-4-yl] O
methyl-1H-benzimidazole-7-carboxylate
Impurity G (EP): 2-Ethoxy-1-[[2'-(1H-tetrazol-5-yl)- N
N
N
MM0776.09- biphenyl-4-yl]methyl]-1H-benzimidazole-7- N
H
HN
N N
N
MM0776.10 yl)biphenyl-4-yl]methyl]-1H-benzimidazole-7- 139481-69-9 100mg N
N
HN
N N
N
O
N
Ethyl 1-[(2'-Cyanobiphenyl-4-yl)methyl]-2-ethoxy-1H- N
MM0776.11 139481-41-7 100mg N
benzimidazole-7-carboxylate O
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-99
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
O
N
MM0776.11- Ethyl 1-[(2'-Cyanobiphenyl-4-yl)methyl]-2-ethoxy-1H- N
139481-41-7 25mg N
0025 benzimidazole-7-carboxylate O
O
O O
MM0776.17- O
O
N N
N2-Tritylcandesartan Cilexetil 886999-34-4 25mg N
N N
0025 N
O
OH
MM0776.18- N N
N N
N2-Tritylcandesartan 894806-43-0 25mg N
0025 N
O
N
MM0487.09A N O
N-Nitrosodimethylamine 0.2 mg/ml in Methanol 62-75-9 1ml
ME-00.20
Cantharidin
O
Capecitabine
O
HN O
F
N
O OH
OH
O N NH2
Impurity A (EP): 4-Amino-1-(5-deoxy- -D-ribofuranosyl)-5- N
MM0992.05- O
fluoropyrimidin-2(1H)-one (5'-Deoxy-5-fluorocytidine) 66335-38-4 25mg F
H
O N O
Impurity B (EP): 1-(5-Deoxy- -D-ribofuranosyl)-5-
MM0992.06- O N
fluoropyrimidine-2,4(1H,3H)-dione (5'-Deoxy-5-fluorouridine) 3094-09-5 25mg F
0025 Related compound B (USP): 5'-deoxy-5-fluorouridine OH
HO
N H2
F
N
O N
Impurity C (EP): 1-(2,3-Di-O-acetyl-5-deoxy- -D-
MM0992.07 161599-46-8 100mg O
ribofuranosyl)-4-amino-5-fluoropyrimidin-2(1H)-one O O
O
O
N H2
F
N
O N
MM0992.07- Impurity C (EP): 1-(2,3-Di-O-acetyl-5-deoxy- -D-
161599-46-8 25mg O
0025 ribofuranosyl)-4-amino-5-fluoropyrimidin-2(1H)-one O O
O
O
HN O
OH
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-100
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
HN O
Impurity E (EP): 3-Methylbutyl [1-(5-Deoxy- -D- F
N
MM0992.09-
ribofuranosyl)-5-fluoro-2-oxo-1,2-dihydropyrimidin-4-yl] 162204-30-0 25mg O N
0025
carbamate O OH
OH
[(3aR,4R,6R,6aR)-6-methyl-2-oxotetrahydrofuro[3,4-d][1,3] HN O
-(pentyloxycarbonyl)cytidine)
0025
O O
N4-(pentyloxycarbonyl)cytidine
O
HN O
F
N
Impurity G (EP): Pentyl [1-(2,3-Di-O-acetyl-5-deoxy- -D-
MM0992.10- O N
ribofuranosyl)-5-fluoro-2-oxo-1,2-dihydropyrimidin-4-yl] 162204-20-8 25mg O
0025 O O
carbamate (Capecitabine Diacetate)
O
O
Caprylic Acid
O
MM3387.00 Caprylic Acid 124-07-2 250mg OH
Capsaicin
HO
MM0016.01- H
O
0025
N-[(4-Hydroxy-3-methoxyphenyl)methyl]octanamide (N- O
N
O
58493-47-3 25mg
0025 Vanillyloctanamide; Caprylic Vanillylamide) HO
Captodiame Hydrochloride
S
N
Captopril
O OH
O
MM0067.00-
Captopril 62571-86-2 250mg HS N
0250
[(2S)-2-methyl-1-oxopropane-3,1-diyl]]- N S
S
O
N
MM0067.01 64806-05-9 100mg
bis[(2S)-pyrrolidine-2-carboxylic] Acid HO O
O
(Captopril Disulfide)
Impurity A (EP): 1,1'-[Disulfanediylbis-
O OH
MM0067.01- [(2S)-2-methyl-1-oxopropane-3,1-diyl]]- N S
S
O
N
64806-05-9 25mg
0025 bis[(2S)-pyrrolidine-2-carboxylic] Acid HO O
O
(Captopril Disulfide)
O
MM0067.07- Impurity B (EP): (2S)-1-[(2S)-3-Bromo-2- O OH
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-101
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
O
Impurity C (EP): (2RS)-2-Methyl-3-sulfanyl-
MM0067.02 26473-47-2 100mg HS OH
propanoic Acid
O
Impurity D (EP): (2RS)-3-Bromo-2-methyl-
MM0067.06 56970-78-6 100mg Br OH
propanoic Acid
O
O OH
Impurity E (EP): (2S)-1-[2-Methylpropanoyl]-
MM0067.08 23500-15-4 100mg N
pyrrolidine-2-carboxylic Acid
O
O OH
MM0067.08- Impurity E (EP): (2S)-1-[2-Methylpropanoyl]-
23500-15-4 25mg N
0025 pyrrolidine-2-carboxylic Acid
Acid)
Impurity J (EP) as Hydrate: (2S)-1-[(2S)-3- O
(Acetylsulfanyl)-2-methylpropanoyl]- O O OH
H2 O
MM0067.05 801293-45-8 100mg S N
pyrrolidine-2-carboxylic Acid Hydrate
(Acetylcaptopril Hydrate)
Impurity J (EP) as Hydrate: (2S)-1-[(2S)-3- O
MM0067.05- (Acetylsulfanyl)-2-methylpropanoyl]- O O OH
H2 O
801293-45-8 25mg S N
N
O
S S
O
O
N
OH
n/a 25mg
0025 3,1-diyl]]]bis[(2S)-pyrrolidine-2-carboxylic]
Acid
O
O O
O
O O
O
O O
Caramiphen Hydrochloride
O
Carbamazepine
N NH2
MM0076.00 Carbamazepine 298-46-4 250mg
N H2
Impurity A (EP): 10,11-Dihydro-5H-dibenzo[b,f]- O
azepine-5-carboxamide (10,11-Dihydro- N
MM0076.04 3564-73-6 100mg
carbamazepine)
Related compound A (USP): 10,11-dihydrocarbamazepine
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-102
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
N H2
Impurity A (EP): 10,11-Dihydro-5H-dibenzo[b,f]- O
MM0076.04- azepine-5-carboxamide (10,11-Dihydro- N
carbamazepine)
3564-73-6 25mg
0025
Related compound A (USP): 10,11-dihydrocarbamazepine
N
MM0076.09 Impurity B (EP): 9-Methylacridine 611-64-3 100mg
MM0076.09- N
Impurity B (EP): 9-Methylacridine 611-64-3 25mg
0025
O O
O O
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-103
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
N NH2
MM0076.01 Carbamazepine 10,11-Epoxide 36507-30-9 100mg
O
MM0076.01- N NH2
Carbamazepine 10,11-Epoxide 36507-30-9 25mg
0025 O
NH
MM0076.07 10-Hydroxyiminodibenzyl 4014-77-1 100mg
HO
MM0076.07- NH
10-Hydroxyiminodibenzyl 4014-77-1 25mg
0025
HO
N N H2
MM0076.10 10-Hydroxy-10,11-dihydrocarbamazepine 29331-92-8 100mg
HO
MM0076.10- N N H2
10-Hydroxy-10,11-dihydrocarbamazepine 29331-92-8 25mg
0025
HO
10-Methoxycarbamazepine (10-Methoxy-5H-dibenz[b,f] N N H2
MM0076.13 28721-09-7 100mg
azepine-5-carboxamide)
O
H
N
10-Ketoiminodibenzyl (10-Oxo-10,11-dihydro-5H-dibenz[b,f]
MM0076.14 21737-58-6 100mg
azepine)
O
H
N
MM0076.14- 10-Ketoiminodibenzyl (10-Oxo-10,11-dihydro-5H-dibenz[b,f]
21737-58-6 25mg
0025 azepine)
O
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-104
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
N N H2
MM0076.17 Oxcarbazepine 28721-07-5 100mg
O
Carbasalate Calcium
O
O O O
Impurity A (EP): 2-(Acetyloxy)benzoic Anhydride O
MM0133.02 1466-82-6 100mg
(Acetylsalicylic Anhydride) O
O O O
MM0133.02- Impurity A (EP): 2-(Acetyloxy)benzoic Anhydride O
1466-82-6 25mg
0025 (Acetylsalicylic Anhydride) O
OH O
Impurity B (EP): 2-[[2-(Acetyloxy)benzoyl]oxy]benzoic O O
MM0133.01 530-75-6 100mg
Acid (Acetylsalicylsalicylic Acid)
O
OH O
MM0133.01- Impurity B (EP): 2-[[2-(Acetyloxy)benzoyl]oxy]benzoic O O
530-75-6 25mg
0025 Acid (Acetylsalicylsalicylic Acid)
O
O
MM0045.00- OH
Impurity C (EP): Salicylic Acid 69-72-7 250mg
0250
OH
OH
MM0133.03- Impurity D (EP): 2-[(2-Hydroxybenzoyl)oxy]benzoic O OH
552-94-3 250mg
0250 Acid (Salicylsalicylic Acid)
O
Carbendazim
O
H
N O
MM2500.00 Carbendazim 10605-21-7 100mg N
H
N
N NH2
N NH2
MM2500.01-
2,3-Diaminophenazine 655-86-7 25mg
0025 N NH2
N NH2
N NH2
MM2500.02-
2-Amino-3-hydroxyphenazine 4569-77-1 25mg
0025 N OH
H
N
MM2500.03 2-Aminobenzimidazole 934-32-7 100mg NH2
N
H
MM2500.03- N
2-Aminobenzimidazole 934-32-7 25mg NH2
0025 N
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-105
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
H
N
MM0474.03 2-Hydroxybenzimidazole 615-16-7 100mg O
N
H
H
N
MM0474.03-
2-Hydroxybenzimidazole 615-16-7 25mg O
0025 N
H
N H2
MM0602.01-
1,2-Phenylenediamine 95-54-5 25mg
0025 N H2
Carbidopa
O
OH
MM1501.00 Carbidopa 38821-49-7 250mg HO
HN
N H2
H2 O
OH
OH
N H2 H2O
MM0643.00 dihydroxyphenyl)-2-methylpropanoic Acid Sesquihydrate (L- 41372-08-1 250mg HO 3
OH
2
MM1501.22- O
(3,4-dihydroxyphenyl)-2-methylpropanoate Hydrochloride 115054-62-1 25mg H 2N HCl
HO
0025 OH
(Methyldopa Methyl Ester Hydrochloride)
Impurity C (EP) as Racemate: (RS)-2-Hydrazino-3-(4- O
O
MM0262.01 Impurity G (EP): 1-(3,4-Dihydroxyphenyl)propan-2-one 2503-44-8 50mg HO
OH
O
MM1501.12- (2RS)-3-(3,4-Dihydroxyphenyl)-2-hydrazino-2- HO
OH
302-53-4 25mg NH
0025 methylpropanoic Acid (rac-Carbidopa) HO H 2N
MM1501.14- O
1-(3,4-Dimethoxyphenyl)propan-2-one 776-99-8 100mg O
0100 O
Carbimazole
N N O
MM1748.00 Carbimazole 22232-54-8 250mg
S O
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-106
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
Carbinoxamine Maleate
Cl
O
MM1135.00- O
N OH
Carbinoxamine Maleate 3505-38-2 250mg OH
N
0250 O
Cl
O +
N
MM1135.01 Carbinoxamine N-Oxide 1256285-70-7 100mg O
N
Cl
2-(4-Chlorobenzoyl)pyridine O
MM1135.02-
Related compound A (USP): (4-Chlorophenyl)(pyridin-2-yl) 6318-51-0 25mg
0025 N
methanone
Cl
4-Chlorophenyl-2-pyridinylmethanol OH
MM1135.03-
Related compound B (USP): (4-Chlorophenyl)(pyridin-2-yl) 27652-89-7 25mg
0025 N
methanol
N,N-Dimethyl-2-[(RS)-1-phenyl(pyridin-2-yl)methoxy]
ethanamine Hydrogen Fumarate (Deschlorocarbinoxamine O
OH
Carbocisteine
O
HO
MM0236.00 Carbocisteine 638-23-3 500mg S OH
O NH2
O
(S)-Carboxymethyl-L-cysteine HO
S OH
MM0236.01
(R/S)-Sulphoxide
5439-87-2 100mg
O O NH2
O
MM0236.01- (S)-Carboxymethyl-L-cysteine HO
S OH
5439-87-2 25mg
0025 (R/S)-Sulphoxide O O NH2
NH
MM0236.02 Lactam of (S)-Carboxymethyl-L-cysteine 62305-89-9 100mg S OH
MM0236.02- NH
Lactam of (S)-Carboxymethyl-L-cysteine 62305-89-9 25mg S OH
0025
O
O
HO
MM0236.03 L-Cysteinesulfinic Acid 1115-65-7 100mg S OH
O NH2
O
MM0236.03- HO
L-Cysteinesulfinic Acid 1115-65-7 25mg S OH
0025 O NH2
MM0236.04- NH
Lactam of (S)-Carboxymethyl-(D,L)-cysteine 14226-97-2 25mg S OH
0025
O
O
O
S O
MM0236.09 Carbocisteine Diisopropyl Ester 792135-12-7 100mg O N H2
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-107
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
HCl
O
MM0236.13- O
Carbocisteine Diethyl Ester Hydrochloride 92282-33-2 25mg S O
0025 O N H2
O
O
S OH HCl
MM0236.14 S-[2-(1-Methylethoxy)-2-oxoethyl]-L-cysteine Hydrochloride n/a 100mg O NH2
O
MM0236.14- O
S OH HCl
S-[2-(1-Methylethoxy)-2-oxoethyl]-L-cysteine Hydrochloride n/a 25mg O NH2
0025
O
O
MM0236.20- O
S O
68114-23-8 25mg HCl
Carbocisteine Diisopropyl Ester Hydrochloride O N H2
0025
Carboplatin
O
MM1519.01- OH
Impurity B (EP): Cyclobutane-1,1-dicarboxylic Acid 5445-51-2 25mg OH
0025
O
O
MM1519.02-
Cyclobutanecarboxylic Acid 3721-95-7 100mg OH
0100
Carbromal
O O
Br
MM1686.00 Carbromal 77-65-6 250mg H2 N N
H
Carbutamide
O O O
S
MM1856.00 Carbutamide 339-43-5 100mg N
H
N
H
H 2N
Cariprazine Hydrochloride
AND Enantiomer
MM3927.00- N Cl
N Cl
Cariprazine 839712-12-8 250mg O
N N
0250 H
Carisoprodol
O O
O O
MM0782.02 Impurity B (EP): 5-Methyl-5-propyl-1,3-dioxan-2-one 7148-50-7 100mg
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-108
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
HO OH
MM0782.03 Impurity C (EP): 2-Methyl-2-propylpropane-1,3-diol 78-26-2 100mg
MM0782.03- HO OH
Impurity C (EP): 2-Methyl-2-propylpropane-1,3-diol 78-26-2 25mg
0025
Carmustine
O
MM0923.01- Impurity A (EP): 1,3-Bis(2-chloroethyl)urea Cl Cl
2214-72-4 25mg N N
0025 Related compound A (USP): 1,3-bis(2-chloroethyl)urea H H
Carprofen
H
N OH
MM1484.00-
Carprofen 53716-49-7 250mg O
0250
Cl
H
N O
MM1484.02- Impurity G (EP): Ethyl (2RS)-2-(6-Chloro-9H-carbazol-2-yl) O
52262-89-2 25mg
0025 propanoate (Carprofen Ethyl Ester)
Cl
H
N
Carbazole
Related compound A (USP): carbazole
MM1484.01 86-74-8 100mg
H
N
MM1484.01- Carbazole
Related compound A (USP): carbazole
86-74-8 25mg
0025
H
N O
MM1484.03- O
Carprofen Methyl Ester 52263-88-4 25mg
0025
Cl
H
N O
MM1484.04- O
Carprofen Isopropyl Ester n/a 25mg
0025 Cl
H
N O
O OH
n/a 25mg H
O OH
0025 Stereoisomers) N
Cl
OH
H
N O
MM1484.06- O
Carprofen 2,3-Butylene Glycol Ester n/a 25mg
0025 Cl
OH
H
N O H
MM1484.07- Carprofen 1,2-Propylene Glycol Esters (Mixture of Regio- and O
N
O
O
OH
n/a 25mg Cl
Cl
0025 Stereoisomers)
OH
H
N O OH
0025 Stereoisomers) Cl
Carvedilol
OH
H
O N
MM0291.00- O
0250 N
H
O
OH
H
propan-2-ol
O N
O
1198090-73-1 25mg N
O
HO
N
methoxyphenoxy)ethylamino)propoxy)-9H-carbazol-9-yl)-3-(2-
(2-methoxyphenoxy)ethylamino)propan-2-ol
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-109
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
MM0291.02- nitrilo]bis[3-(9H-carbazol-4-yloxy)propan-2-ol] O
OH
N
O NH
ethylazanediyl)bis(1-(9H-carbazol-4-yloxy)propan-2-ol) H
(benzyl(2-(2-methoxyphenoxy)ethyl)amino)propan-2-ol
Impurity D (EP): 1-(9H-Carbazol-4-yloxy)-3-[4-[2-hydroxy-3- O
OH
H
N
O
O
yl]propan-2-ol
0025 yl]propan-2-ol
H 2N
MM0291.09- 2-(2-Methoxyphenoxy)ethylamine O
O
Related compound E (USP): 2-(2-Methoxyphenoxy)ethyl 1836-62-0 25mg
0025 amine hydrochloride monohydrate
O
O
MM0291.10- 4-(2,3-Epoxypropoxy)carbazole
Related compound D (USP): 4-(Oxiran-2-ylmethoxy)-9H- 51997-51-4 25mg
0025 carbazole N
H
2-(2-Methoxyphenoxy)ethylamine H 2N
O
Hydrochloride O HCl
MM0291.12-
4-Hydroxycarbazole 52602-39-8 25mg
0025
N
H
OH
O OH
MM0291.14-
3-(9H-Carbazol-4-yloxy)propane-1,2-diol 123119-89-1 25mg
0025 N
H
OH
O N
MM0291.17- 1-(9H-Carbazol-4-yloxy)-3-[[2-(2-methoxyphenoxy)ethyl](1- O
O
1246819-01-1 25mg
0025 methylethyl)amino]propan-2-ol (N-Isopropylcarvedilol) N
H
OH OH
O N
MM0291.21- 1-(9H-Carbazol-4-yloxy)-3-[hydroxy[2-(2-methoxyphenoxy) O
O
1059573-38-4 25mg
N
0025 ethyl]amino]-2-propanol (N-Hydroxycarvedilol) H
O
OH
O N
MM0291.22- O
O
N-Formylcarvedilol n/a 25mg
0025 N
H
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-110
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
Cefaclor
O OH
O Cl
NH2
Impurity A (EP): (2R)-2-Amino-2-phenylacetic OH
MM0253.12 875-74-1 100mg
Acid (D-Phenylglycine) O
NH2
MM0253.12- Impurity A (EP): (2R)-2-Amino-2-phenylacetic OH
875-74-1 25mg
0025 Acid (D-Phenylglycine) O
O
Amino-2-phenylacetyl]amino]-3-chloro-8-oxo-5-thia- NH2
H
N
Cl
(delta-3-Cefaclor)
Impurity D (EP): (2R,6R,7R)- and (2S,6R,7R)-7-[[(2R)-2- O OH
O
MM0326.03- Amino-2-phenylacetyl]amino]-3-chloro-8-oxo-5-thia- NH2
H
N
Cl
152575-13-8 25mg N
0025 1-azabicyclo[4.2.0]oct-3-ene-2-carboxylic Acid O
H
S
(delta-3-Cefaclor)
HO N
HO N
MM0253.08-
Impurity F (EP): 3-Phenylpyrazin-2-ol 73200-73-4 25mg N
0025
Cefadroxil Monohydrate
O OH
H 2O
O
N H2 N
MM0972.00 Cefadroxil Monohydrate 66592-87-8 250mg H
N
S
H
O
HO
NH2
NH2
MM0232.09- Impurity A (EP): (2R)-2-Amino-2-(4-hydroxyphenyl)- OH
22818-40-2 25mg
0025 acetic Acid HO
O
oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid
Impurity B (EP): (6R,7R)-7-Amino-3-methyl-8-oxo- O OH
5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic
O
MM0811.01- Acid (7-ADCA; 7-Aminodesacetoxycephalosporanic N
Acid)
22252-43-3 25mg
0025
Related compound B (USP): (6R,7R)-7-amino-3-methyl-8- H 2N
H
S
oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid
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Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
NH2
Impurity A (EP): (2R)-2-Amino-2-phenylacetic OH
MM0253.12 875-74-1 100mg
Acid (D-Phenylglycine) O
NH2
MM0253.12- Impurity A (EP): (2R)-2-Amino-2-phenylacetic OH
875-74-1 25mg
0025 Acid (D-Phenylglycine) O
O OH
Impurity B (EP): (6R,7R)-7-Amino-3-methyl-8-oxo-
O
5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic N
MM0811.01 22252-43-3 100mg
Acid (7-Aminodesacetoxycephalosporanic Acid;
S
7-ADCA) H 2N
H
O OH
Impurity B (EP): (6R,7R)-7-Amino-3-methyl-8-oxo-
O
MM0811.01- 5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic N
22252-43-3 25mg
0025 Acid (7-Aminodesacetoxycephalosporanic Acid;
S
7-ADCA) H 2N
H
O
MM0605.11- HCl
Methyl (2R)-2-Amino-2-phenylacetate Hydrochloride 19883-41-1 25mg O
0025 N H2
O OH
O
(6R,7R)-3-[(Acetyloxy)methyl]-7-amino-8-oxo-5-thia-1- O
N O
MM0238.08 957-68-6 100mg
azabicyclo[4.2.0]oct-2-ene-2-carboxylic Acid (7-ACA) H 2N S
H
O OH
O
MM0238.08- (6R,7R)-3-[(Acetyloxy)methyl]-7-amino-8-oxo-5-thia-1- O
N O
957-68-6 25mg
0025 azabicyclo[4.2.0]oct-2-ene-2-carboxylic Acid (7-ACA) H 2N S
H
HO N
HO N
MM0253.08-
3-Phenylpyrazin-2-ol 73200-73-4 25mg N
0025
Cefalonium Dihydrate
H2 O O O
2
O
N
N
S
N
+
NH2
H H
O
Cefazolin Sodium
+
O O Na
O
N
N O N S
MM0238.00 Cefazolin Sodium 27164-46-1 100mg N
N
N S S N
H H
N
S
Impurity E (EP): 5-Methyl-1,3,4-thiadiazol-2-thiol SH
MM0238.05 29490-19-5 100mg
(MMTD) N N
S
MM0238.05- Impurity E (EP): 5-Methyl-1,3,4-thiadiazol-2-thiol SH
29490-19-5 25mg
0025 (MMTD) N N
O OH
Impurity H (EP): (6R,7R)-3-[(Acetyloxy)methyl]-7- O
O
O OH
N
MM0487.09A N O
N-Nitrosodimethylamine 0.2 mg/ml in Methanol 62-75-9 1ml
ME-00.20
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-112
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
Cefdinir
O OH
O
S O N
MM1042.00 Cefdinir 91832-40-5 250mg H 2N
N N S
H H
N
OH
O
Impurity D (EP): (2Z)-(2-Aminothiazol-4-yl)(methoxyimino) N
MM1475.01 65872-41-5 100mg N OH
acetic Acid H 2N
S O
O
MM1475.01- Impurity D (EP): (2Z)-(2-Aminothiazol-4-yl)(methoxyimino) N
65872-41-5 25mg N OH
0025 acetic Acid H 2N
S O
Cefetamet
O OH
O
MM0811.01 7-Aminodesacetoxycephalosporanic Acid 22252-43-3 100mg N
H 2N S
H
O OH
O
MM0811.01-
7-Aminodesacetoxycephalosporanic Acid 22252-43-3 25mg N
0025
H 2N S
H
Cefixime Trihydrate
O
O OH
H2 O OH
O
Cefixime Trihydrate
3 O
N N
MM0316.00 125110-14-7 250mg H
N N
H2 N S
H
S O
Cefoperazone Sodium
SH
SH
MM0853.03-
Impurity C (EP): 1-Methyl-1H-tetrazole-5-thiol 13183-79-4 25mg N N
0025
N N
O OH
Impurity E (EP): (6R,7R)-3-[(Acetyloxy)methyl]-7- O
O
O OH
N
MM0487.09A N O
N-Nitrosodimethylamine 0.2 mg/ml in Methanol 62-75-9 1ml
ME-00.20
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Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
Cefotaxime Sodium
+
O O Na
O
O O
S
O
H
S O
O
N
MM1475.01 (2Z)-(2-Aminothiazol-4-yl)(methoxyimino)acetic Acid 65872-41-5 100mg N OH
H 2N
S O
O
MM1475.01- N
(2Z)-(2-Aminothiazol-4-yl)(methoxyimino)acetic Acid 65872-41-5 25mg N OH
0025 H 2N
S O
O OH
O
(6R,7R)-3-[(Acetyloxy)methyl]-7-amino-8-oxo-5-thia-1- O
N O
MM0238.08 957-68-6 100mg
azabicyclo[4.2.0]oct-2-ene-2-carboxylic Acid (7-ACA) H 2N S
H
O OH
O
MM0238.08- (6R,7R)-3-[(Acetyloxy)methyl]-7-amino-8-oxo-5-thia-1- O
N O
957-68-6 25mg
0025 azabicyclo[4.2.0]oct-2-ene-2-carboxylic Acid (7-ACA) H 2N S
H
O
MM0251.04- S-Benzothiazol-2-yl (2Z)-(2-aminothiazol-4-yl)(methoxyimino) N N
80756-85-0 25mg N S
H2 N S
0025 thioacetate S O
Cefotetan Disodium
N
MM0487.09A N O
N-Nitrosodimethylamine 0.2 mg/ml in Methanol 62-75-9 1ml
ME-00.20
Cefoxitin Sodium
+
O O Na
O
O
S
O NH2
O H
O
Cefradine
O OH
O
NH2 N
MM0833.00 Cefradine 38821-53-3 250mg H
N
S
H
O
O OH
Impurity A (EP): (6R,7R)-7-Amino-3-methyl-8-oxo-
O
5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic N
MM0811.01 22252-43-3 100mg
Acid (7-Aminodeacetoxycephalosporanic Acid,
S
7-ADCA) H 2N
H
O OH
Impurity A (EP): (6R,7R)-7-Amino-3-methyl-8-oxo-
O
MM0811.01- 5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic N
22252-43-3 25mg
0025 Acid (7-Aminodeacetoxycephalosporanic Acid,
S
7-ADCA) H 2N
H
Ceftiofur
O OH
O
O O
H
S
S
O
S O
Ceftriaxone Sodium
O
+ +
O O Na O Na
N
O
O
H
N
N
H
S
S N
N H2O
7
S
2
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-114
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
O
O
MM0251.03- Impurity C (EP): 2-Methyl-3-sulfanyl-1,2-dihydro-1,2,4- N
58909-39-0 25mg
0025 triazine-5,6-dione NH
HS N
S
N
80756-85-0 25mg N
0025 yl)(methoxyimino)thioacetate H2 N
S O
S
Cefuroxime Axetil
O OH
O
O O
S
O NH2
H
O
O O
MM1341.08- (methoxyimino)acetyl]amino]-5a,6-dihydro-3H,7H-azeto[2,1- N N
947723-87-7 25mg H
O N
0025 b]furo[3,4-d][1,3]thiazine-1,7(4H)-dione S
H
O
(Descarbamoylcefuroxime Lactone)
Cefuroxime Sodium
+
O O Na
O
O O
S
O NH2
H
O
O OH
O
O O
N N O NH2
H
MM1341.10 Cefuroxime 55268-75-2 100mg O N
S
H
O
O
MM1341.11- O OH
2-(Furan-2-yl)-2-oxoacetic Acid 1467-70-5 25mg
0025
O
Celecoxib
O O
S
N H2
O O
Impurity A (EP): 4-[5-(3-Methylphenyl)-3-(trifluoromethyl)-1H- S
N H2
F
(trifluoromethyl)-1H-pyrazol-1-yl]benzenesulfonamide F F S
NH2
O O
HO
O O
4-[5-[4-(Hydroxymethyl)phenyl]-3- S
NH2
MM0344.02 (trifluoromethyl)-1H-pyrazol-1-yl]- 170571-00-3 100mg N
benzenesulfonamide F
N
F
F
HO
O O
MM0344.02- 4-[5-[4-(Hydroxymethyl)phenyl]-3- S
NH2
(trifluoromethyl)-1H-pyrazol-1-yl]- 170571-00-3 25mg N
0025 benzenesulfonamide F
N
F
F
O
HO
4-[1-[4-(Aminosulfonyl)phenyl]-3- O O
S
N H2
MM0344.03 (trifluoromethyl)-1H-pyrazol-5- 170571-01-4 100mg N
yl]benzoic Acid N
F
F
F
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-115
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
O
HO
4-[1-[4-(Aminosulfonyl)phenyl]-3- O O
S
MM0344.03- N H2
(trifluoromethyl)-1H-pyrazol-5- 170571-01-4 25mg N
0025 yl]benzoic Acid N
F
F
F
O O
S
MM0344.08- NH2
HCl
[4-(Aminosulfonyl)phenyl]hydrazine Hydrochloride 17852-52-7 25mg HN
0025
NH2
MM0344.10-
1-(4-Methylphenyl)-4,4,4-trifluorobutane-1,3-dione 720-94-5 25mg
0025 O
F
F O
F
MM0344.11-
3-(4-Methylphenyl)-5-(trifluoromethyl)-1H-pyrazole 219986-64-8 25mg
0025 N
NH
F
F
F
O
MM0344.12- O
Methyl 4-Methylbenzoate 99-75-2 100mg
0100
O O
S
N H2
MM0344.19- 4-[5-(2-Methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl]
170569-99-0 25mg N
0025 benzenesulfonamide N
F
F
F
Celiprolol Hydrochloride
O
OH
H
MM0128.00- O N
N
H
HCl
0250
Impurity A (EP): 1-[5-Amino-2-[(2RS)-3-[(1,1- O
OH
H
O N
MM0128.01 dimethylethyl)amino]-2-hydroxypropoxy]- 56980-94-0 100mg
phenyl]ethanone H 2N
phenyl]-3-(1,1-dimethylethyl)urea H H
N
0025 phenyl]-3-(1,1-dimethylethyl)urea H H
O
OH
N
O
1,1-diethylurea
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-116
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
O
OH
N
O
MM0128.05- ethyl)imino]bis[(2-hydroxypropane- HN
O N O
NH
n/a 25mg
0025 1,3-diyl)oxy(3-acetyl-1,4-phenylene)]]- O N N O
bis(3,3-diethylurea)
O
79881-89-3 25mg
0025 1,1-diethylurea N N
H
O
O
Impurity G (EP): 3-[3-Acetyl-4-[[(RS)-oxiranyl]- O
O
O
O
MM0128.06- Impurity G (EP): 3-[3-Acetyl-4-[[(RS)-oxiranyl]- O
O
56980-98-4 25mg
0025 methoxy]phenyl]-1,1-diethylurea N N
H
O
OH
Br
O
MM0128.04 2-hydroxypropoxy]phenyl]-1,1-diethylurea 85045-98-3 100mg N N
H
(Bromhydrin Compound)
O
OH
Br
O
2-hydroxypropoxy]phenyl]-1,1-diethylurea 85045-98-3 25mg N N
H
0025 (Bromhydrin Compound)
O
MM0128.11- OH HCl
3-Acetyl-4-hydroxyaniline Hydrochloride 57471-32-6 25mg
0025 H2 N
MM0128.58- OH
5-Acetamido-2-hydroxyacetophenone 7298-67-1 25mg O
0025
N
H
Cethexonium Bromide
AND Enantiomer
rac-trans-2-Dimethylaminocyclohexanol N
MM0501.01 40571-56-0 100mg OH
Hydrochloride HCl
AND Enantiomer
MM0501.01- rac-trans-2-Dimethylaminocyclohexanol N
40571-56-0 25mg OH
0025 Hydrochloride HCl
Cetirizine Dihydrochloride
O
Cl O
N OH
MM0380.00-
Cetirizine Dihydrochloride
N
Cl
NH
N
Impurity A (EP): (RS)-1-[(4-Chlorophenyl)-
MM0380.01 303-26-4 100mg
phenylmethyl]piperazine
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-117
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
Cl
NH
N
MM0380.01- Impurity A (EP): (RS)-1-[(4-Chlorophenyl)-
303-26-4 25mg
0025 phenylmethyl]piperazine
2-[4-[(4-Chlorophenyl)phenylmethyl]- N O
Dihydrochloride
Impurity B (EP) as Dihydrochloride: (RS)- Cl
N
OH
MM0380.02- 2-[4-[(4-Chlorophenyl)phenylmethyl]- N O
n/a 25mg
0025 piperazin-1-yl]acetic Acid HCl
2
Dihydrochloride
Impurity C (EP) as Dihydrochloride: (RS)- O
O
N OH
2-[2-[4-[(2-Chlorophenyl)phenylmethyl]- N
MM0380.03 n/a 100mg
piperazin-1-yl]ethoxy]acetic Acid Cl HCl
2
Dihydrochloride
Impurity C (EP) as Dihydrochloride: (RS)- O
O
N OH
MM0380.03- 2-[2-[4-[(2-Chlorophenyl)phenylmethyl]- N
n/a 25mg
0025 piperazin-1-yl]ethoxy]acetic Acid Cl HCl
2
Dihydrochloride
phenylmethyl]piperazine Cl
346451-15-8 25mg N
0025 phenylmethyl]piperazine Cl
N
N
O
O
O
OH
N
N
O
O
O
OH
OH
N
OH
N
N
N
OH
N
N
OH
Cl
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-118
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
MM0380.09-
4-Chlorobenzhydrol 119-56-2 25mg
0025 OH
Cl
Cl
MM0380.10-
4-Chlorobenzophenone 134-85-0 25mg
0025 O
Cl
O
O
Cl + O
N OH
N
HCl
2
HCl
2
0025 phenylmethyl]piperazin-1-yl]ethoxy]acetic acid ethyl ester
O
Cl O
N O
O
Cl O
N O
MM0380.16-
Methyl Ester of Cetirizine Dihydrochloride
N
HCl
83881-48-5 25mg 2
0025
3-Chlorocetirizine Dihydrochloride O
O
((RS)-2-[2-[4-[(3-Chlorophenyl)phenyl- Cl
N
N OH
Dihydrochloride)
3-Chlorocetirizine Dihydrochloride O
O
MM0380.17- ((RS)-2-[2-[4-[(3-Chlorophenyl)phenyl- Cl
N
N OH
1232460-29-5 25mg
0025 methyl]piperazin-1-yl]ethoxy]acetic Acid HCl
2
Dihydrochloride)
OH
2-(4-Benzhydrylpiperazin-1-yl)ethan-1-ol Dihydrochloride N
MM0380.20- N
HCl
Related compound B (USP): 2-(4-Benzhydrylpiperazin-1-yl) 108983-83-1 25mg 2
0025
ethan-1-ol
O O
MM0380.23- S
N
1-[(4-Methylphenyl)sulfonyl]piperazine 27106-51-0 25mg
0025 HN
Cetrimide
Chenodeoxycholic Acid
O
H
OH
MM0836.00- H
Impurity A (EP): Ursodeoxycholic Acid 128-13-2 250mg H H
0250 HO
H
OH
O
OH
H
OH
MM0835.02- Impurity B (EP): 3 ,7 ,12 -Trihydroxy-5 -cholan-24-oic Acid H
81-25-4 250mg H H
0250 (Cholic Acid) HO
H
OH
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-119
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
434-13-9 25mg
0025 (Lithocholic Acid) HO
H H
O
OH
H
OH
MM0835.05- Impurity E (EP): 3 ,12 -Dihydroxy-5 -cholan-24-oic Acid H
83-44-3 250mg H H
0250 (Deoxycholic Acid) HO
H
H
O
H
HO OH
H
H
O
MM0835.07-
Impurity G (EP): Methyl 3 ,7 -Dihydroxy-5 -cholan-24-oate 10538-55-3 25mg H
H
H
0025 HO
H
OH
O
OH
H O
MM0835.12- H
Methyl Cholate 1448-36-8 25mg H H
0025 HO
H
OH
Chloral Hydrate
OH
Cl
MM1650.00 Chloral Hydrate 302-17-0 250mg OH
Cl Cl
Chlorambucil
OH
Cl O
Cl
Cl O
N
MM0821.08 Chlorambucil Methyl Ester 79481-83-7 100mg
Cl
Cl O
N
MM0821.09 Chlorambucil Ethyl Ester 64977-24-8 100mg
Cl
Cl O
N
MM0821.10 Chlorambucil Isopropyl Ester 77063-20-8 100mg
Cl
Chloramphenicol
O
+
OH N
O O
MM0516.00 Chloramphenicol 56-75-7 500mg Cl
N
H
Cl OH
O
Impurity A (EP): (1R,2R)-2-Amino-1-(4-nitrophenyl)propane- +
OH N
O
MM0516.01 1,3-diol ((D)-(-)-threo-2-Amino-1-(4-nitrophenyl)-1,3- 716-61-0 100mg
H 2N
propanediol)) OH
O
Impurity A (EP): (1R,2R)-2-Amino-1-(4-nitrophenyl)propane- +
OH N
MM0516.01- O
1,3-diol ((D)-(-)-threo-2-Amino-1-(4-nitrophenyl)-1,3- 716-61-0 25mg
0025 H 2N
propanediol)) OH
MM1255.06-
Impurity B (EP): 4-Nitrobenzaldehyde 555-16-8 25mg O
0025 +
N
O
Chlorcyclizine Hydrochloride
Cl
N
N
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-120
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
O
Cl +
N
N
MM1653.01 Chlorcyclizine N-Oxide 10457-56-4 100mg
O
Cl +
N
MM1653.01- N
Chlorcyclizine N-Oxide 10457-56-4 25mg
0025
Chlordiazepoxide Hydrochloride
H
N
N
O
HCl
H
N
N
MM0028.08- +
Chlordiazepoxide 58-25-3 CS 250mg Cl N
0250 O
H O
Impurity A (EP): 7-Chloro-5-phenyl-1,3-dihydro- N
2H-1,4-benzodiazepin-2-one 4-Oxide +
Cl N
MM0028.02 (Demoxepam) 963-39-3 100mg O
Related compound A (USP): 7-Chloro-1,3-dihydro-5-phenyl-
2H-1,4-benzodiazepin-2-one 4-Oxide
H O
Impurity A (EP): 7-Chloro-5-phenyl-1,3-dihydro- N
2H-1,4-benzodiazepin-2-one 4-Oxide +
MM0028.02- Cl N
(Demoxepam) 963-39-3 25mg O
0025 Related compound A (USP): 7-Chloro-1,3-dihydro-5-phenyl-
2H-1,4-benzodiazepin-2-one 4-Oxide
N
Cl
+
N
Impurity B (EP): 6-Chloro-2-(chloromethyl)-4- Cl O
MM0028.04 5958-24-7 100mg
phenylquinazoline 3-Oxide
N
Cl
+
N
MM0028.04- Impurity B (EP): 6-Chloro-2-(chloromethyl)-4- Cl O
5958-24-7 25mg
0025 phenylquinazoline 3-Oxide
N H2
O
MM0028.03- Impurity C (EP): (2-Amino-5-chlorophenyl)phenyl- Cl
719-59-5 25mg
0025 methanone (Aminochlorobenzophenone)
Chlorhexidine Diacetate
H H H
N N N
MM0162.00- NH NH O
0250 N
H
N
H
N
H
Cl
MM0162.07- O
Impurity F (EP): 1-(4-Chlorophenyl)urea ((4-Chlorophenyl)
140-38-5 25mg N NH2
0025 urea) H
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-121
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
Cl
Cl
MM0162.05-
Impurity P (EP): 4-Chloroaniline 106-47-8 25mg
0025 NH2
H H
N N
N
NH
MM0162.16-
1,1'-(Hexane-1,6-diyl)bis[3-cyanoguanidine] 15894-70-9 25mg
0025 NH
N
N N
H H
Cl
MM0840.06- N-(4-Chlorophenyl)-N -cyanoguanidine NH
N
1482-62-8 25mg N N
0025 H H
MM0162.17- H2 N
NH2 HCl
Hexane-1,6-diamine Dihydrochloride 6055-52-3 25mg 2
0025
Cl
MM0162.23- NH NH
HCl
1-(4-Chlorophenyl)biguanide Hydrochloride 4022-81-5 25mg N
H
N
H
N H2
0025
Chlorhexidine Dihydrochloride
H H H
N N N
NH NH
MM0946.00-
Chlorhexidine Dihydrochloride
Cl
HCl
3697-42-5 250mg Cl 2
NH NH
0250 N
H
N
H
N
H
Chlormadinone Acetate
O
O
H
MM0529.00 Chlormadinone Acetate 302-22-7 100mg H H
O
O
Cl
MM0222.09- OH
H
17 -Hydroxyprogesterone 68-96-2 25mg
0025 H H
O
O O
S
OH H2O
MM0598.02 4-Methylbenzenesulphonic Acid Hydrate 6192-52-5 100mg
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-122
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
Chlormezanone
Cl
O O
S
MM0017.00 Chlormezanone 80-77-3 250mg
N
O
MM0017.03 4-Chlorobenzaldehyde 104-88-1 100mg Cl
H
O
MM0017.03-
4-Chlorobenzaldehyde 104-88-1 25mg Cl
0025 H
Chlorobutanol Hemihydrate
OH
Cl H2 O
MM0535.00 Chlorobutanol Hemihydrate 6001-64-5 500mg
Cl Cl
2
Chlorocresol
OH
MM0459.00-
Chlorocresol 59-50-7 250mg
0250 Cl
Chloropyramine Hydrochloride
Cl
Cl
MM1894.04- HCl
Chloropyramine N-Oxide Hydrochloride n/a 25mg N N
N
+
0025 O
Cl
1-[(4-Chlorophenyl)methyl]-2,3-dihydroimidazo[1,2-a] N
MM1894.03 63111-28-4 100mg +
pyridinium Chloride N
Cl
Cl
MM1894.03- 1-[(4-Chlorophenyl)methyl]-2,3-dihydroimidazo[1,2-a] N
63111-28-4 25mg +
0025 pyridinium Chloride N
Cl
Chloroquine Phosphate
Cl N
O OH
P
MM1055.00- HO OH
2
Chloroquine Phosphate 50-63-5 250mg HN
N
0250
Chloroquine Sulfate
Cl N
Chloroxylenol
OH
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-123
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
Cl
OH
2-Chloro-3,5-dimethylphenol
MM1997.01 5538-41-0 100mg
Related compound A (USP): 2-chloro-3,5-dimethylphenol
Cl
OH
MM1997.01- 2-Chloro-3,5-dimethylphenol
5538-41-0 25mg
0025 Related compound A (USP): 2-chloro-3,5-dimethylphenol
O
MM0090.00-
Chlorphenamine Maleate 113-92-8 250mg N
OH
OH
0250 N
O
Chlorophenyl)-4-(dimethylamino)-2- N
HCl
MM0090.03 2575516-39-9 100mg
[2-(dimethylamino)ethyl]butanenitrile N N
2
Dihydrochloride
Impurity A (EP) as Dihydrochloride: 2-(4- Cl
MM0090.03- Chlorophenyl)-4-(dimethylamino)-2- N
HCl
2575516-39-9 25mg
0025 [2-(dimethylamino)ethyl]butanenitrile N N
2
Dihydrochloride
H
Impurity B (EP): N-(Pyridin-2-yl)pyridin-2-amine N N N
MM0090.04 (2,2'-Dipyridylamine) 1202-34-2 100mg
Related compound B (USP): di(pyridin-2-yl)amine
H
Impurity B (EP): N-(Pyridin-2-yl)pyridin-2-amine N N N
MM0090.04-
(2,2'-Dipyridylamine) 1202-34-2 25mg
0025 Related compound B (USP): di(pyridin-2-yl)amine
Impurity C (EP) as Maleate: (3RS)-3-(4-Chloro- Cl
phenyl)-N-methyl-3-(pyridin-2-yl)propan-1- O
OH
MM0090.13 amine Maleate 22630-25-7 100mg N
OH
(pyridin-2-yl)propan-1-amine
Impurity C (EP) as Maleate: (3RS)-3-(4-Chloro- Cl
MM0090.13- phenyl)-N-methyl-3-(pyridin-2-yl)propan-1- O
OH
amine Maleate 22630-25-7 25mg N
OH
0025 Related compound C (USP): 3-(4-chlorophenyl)-N-methyl-3- NH
O
(pyridin-2-yl)propan-1-amine
Cl
OH
MM0090.05 phenyl)-4-(dimethylamino)-2-(pyridin-2- n/a 100mg N
N
OH
yl)butanenitrile Maleate O
Cl
OH
Cl
2-(4-Chlorophenyl)-4-dimethylaminobutyronitrile HCl
MM0090.14 854863-55-1 100mg
Hydrochloride N
N
Cl
Cl
O
OH
MM0090.15 Chlorphenamine N-Oxide Maleate 2575516-38-8 100mg OH
N +
N
O O
Cl
+
N
MM0090.16 1-(4-Chlorophenyl)-2,3-dihydro-1H-indolizin-4-ium Chloride n/a 100mg Cl
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-124
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
Cl
O
MM1135.02-
2-(4-Chlorobenzoyl)pyridine 6318-51-0 25mg
0025 N
Chlorphenesin Carbamate
OH
O O N H2
MM1996.00 Chlorphenesin Carbamate 886-74-8 50mg O
Cl
61514-96-3 25mg O OH
0025 propanediol 2-Carbamate)
Cl
Chlorphenoxamide
Cl
O O
Chlorphenoxamide
Cl
MM1990.00 3576-64-5 100mg O + N
N OH
O
Chlorphenoxamine Hydrochloride
Cl
O
+
MM1291.02 Chlorphenoxamine N-Oxide 110203-91-3 100mg N
O
Cl
Chlorpromazine Hydrochloride
N N
MM0420.00 Chlorpromazine Hydrochloride 69-09-0 500mg S
HCl
Cl
(Chlorpromazine Sulfoxide)
Cl
propane-1,3-diamine Dihydrochloride Cl
HCl
2
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-125
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
NH
MM0420.04 Impurity E (EP): 2-Chloro-10H-phenothiazine 92-39-7 100mg S
Cl
MM0420.04- NH
Impurity E (EP): 2-Chloro-10H-phenothiazine 92-39-7 25mg S
0025
Cl
O
+
MM0420.02- N N OH
Chlorpromazine Sulphoxide N-Oxide Maleate 150111-59-4 25mg O
S
O
OH
0025 Cl
O
+ HCl
Chlorpromazine Sulfone N-Oxide Hydrochloride N N
MM0420.11 109724-46-1 100mg O S O
O
(Chlorpromazine N,S,S-Trioxide Hydrochloride) Cl
+ HCl
MM0420.11- Chlorpromazine Sulfone N-Oxide Hydrochloride N N
109724-46-1 25mg O S O
O
0025 (Chlorpromazine N,S,S-Trioxide Hydrochloride) Cl
MM0420.12- N N
HCl
Chlorpromazine Sulfone Hydrochloride 18683-73-3 25mg O S
O
0025 Cl
+
N N
HCl
MM0420.13 Chlorpromazine N-Oxide Hydrochloride n/a 100mg S O
Cl
Chlorpropamide
O O O
S
MM1635.00 Chlorpropamide 94-20-2 250mg N
H
N
H
Cl
O
MM1635.01-
Impurity B (EP): 1,3-Dipropylurea 623-95-0 25mg N N
0025 H H
Chlorprothixene Hydrochloride
N HCl
MM1321.00 Chlorprothixene Hydrochloride 6469-93-8 250mg S
Cl
OH
OH
MM1321.01- Impurity A (EP): (RS)-2-Chloro-9-[3-(dimethylamino)- N
4295-65-2 25mg S
0025 propyl]-9H-thioxanthen-9-ol
Cl
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-126
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
0025 Hydrochloride Cl
O
Cl
MM1321.05 Impurity E (EP): 2-Chloro-9H-thioxanthen-9-one 86-39-5 100mg
S
O
MM1321.05- Cl
Impurity E (EP): 2-Chloro-9H-thioxanthen-9-one 86-39-5 25mg
0025 S
Chlorquinaldol
OH
Cl N
OH
N
MM0390.01 8-Hydroxyquinaldine (8-Hydroxy-2-methylquinoline) 826-81-3 100mg
OH
MM0390.01- N
8-Hydroxyquinaldine (8-Hydroxy-2-methylquinoline) 826-81-3 25mg
0025
Chlortalidone (Chlorthalidone)
H O
O O N
HO
S
MM0297.00 Chlortalidone 77-36-1 250mg H2 N
Cl
Chlortetracycline Hydrochloride
OH O OH O O
OH
N H2
OH O OH O O
OH
(Dimethylamino)-3,6,10,12,12a-pentahydroxy-6-methyl-1,11- H H
N H2
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-127
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
OH O OH O O
OH
N H2
Chlorzoxazone
O
O
MM0908.00 Chlorzoxazone 95-25-0 250mg N
Cl
H
OH
2-Amino-4-chlorophenol
MM0908.01 95-85-2 100mg
Related compound A (USP): 2-Amino-4-chlorophenol Cl N H2
OH
MM0908.01- 2-Amino-4-chlorophenol
95-85-2 25mg
0025 Related compound A (USP): 2-Amino-4-chlorophenol Cl N H2
Cholecalciferol
HO
MM0249.00- H
Cholecalciferol 67-97-0 250mg H
0250
434-16-2 25mg
0025 (7,8-Didehydrocholesterol; Provitamin D3) HO
H H
H
MM3002.00 Alfacalcidol 41294-56-8 50mg
HO OH
H
HO
H H2 O
MM1549.00 Calcifediol Monohydrate 63283-36-3 100mg
HO
Cholesterol
H
MM0206.00-
Cholesterol 57-88-5 250mg H
H
H
0250 HO
Cholic Acid
O
OH
H
OH
MM0835.02- H
Cholic Acid 81-25-4 250mg H H
0250 HO
H
OH
O
OH
H
MM3876.01- O
H
Cholic Acid Ethyl Ester 47676-48-2 25mg H H
0025 HO
H
OH
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-128
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
Ciclesonide
O
O O
H
H H
O
Ciclopirox
OH
N O
MM3420.00 Ciclopirox 29342-05-0 250mg
Ciclopirox Olamine
OH
N O
Ciclosporin (Cyclosporine)
O O
N N
N N
H
O NH O O
O N
O
MM0241.00 Ciclosporin 59865-13-3 250mg N
N
O
N
N
O
NH
H
OH
H
O O
Cidofovir
NH2
OH
Cilastatin Sodium
O O +
Na
Cilastatin Sodium
HO S O
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-129
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
MM1092.20- H 2N
(1S)-2,2-Dimethylcyclopropanecarboxamide 75885-58-4 25mg
0025
O
Cilazapril
OH
O
O
O O
Cilostazol
H
N O
N N
N
3,4-Dehydrocilostazol (6-[4-(1-Cyclohexyl-1H-tetrazol-5-yl)- H
N O
N N
butoxy]-1H-quinolin-2-one) N
N O
MM0796.01 73963-62-9 100mg
Related compound B (USP): 6-[4-(1-Cyclohexyl-1H-tetrazol-
5-yl)-butoxy]-1H-quinolin-2-one
3,4-Dehydrocilostazol (6-[4-(1-Cyclohexyl-1H-tetrazol-5-yl)- H
N O
N N
MM0796.01- butoxy]-1H-quinolin-2-one) N
N O
73963-62-9 25mg
0025 Related compound B (USP): 6-[4-(1-Cyclohexyl-1H-tetrazol-
5-yl)-butoxy]-1H-quinolin-2-one
6-Hydroxy-3,4-dihydro-1H-quinolin-2-one H
N O
MM0796.02 Related compound A (USP): 6-hydroxy-3,4-dihydro-1H-quinolin- 54197-66-9 100mg
2-one HO
MM0796.02- 6-Hydroxy-3,4-dihydro-1H-quinolin-2-one H
N O
Related compound A (USP): 6-hydroxy-3,4-dihydro-1H-quinolin- 54197-66-9 25mg
0025 2-one HO
1-(4-(5-Cyclohexyl-1H-tetrazol-1-yl)butyl)-6-(4-(1-cyclohexyl-
1H-tetrazol-5-yl)butoxy)-3,4-dihydroquinolin-2(1H)-one N
N
yl)butyl)-6-(4-(1-cyclohexyl-1H-tetrazol-5-yl)butoxy)-3,4-
dihydroquinolin-2(1H)-one
N N
N
N Cl
MM0796.04-
5-(4-Chlorobutyl)-1-cyclohexyl-1H-tetrazole 73963-42-5 25mg
0025
N
MM0487.09A N O
N-Nitrosodimethylamine 0.2 mg/ml in Methanol 62-75-9 1ml
ME-00.20
Cimetidine
N
N N
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-130
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
methyl]sulphanyl]ethyl]amino]methylene]urea
N N NH2
HN HCl
MM0020.03 52568-80-6 100mg S
N N 2
H H
Dihydrochloride
(Cimetidine Amide Dihydrochloride)
Impurity C (EP) as Dihydrochloride: 1-[(Methyl-
MM0020.03- amino)[[2-[[(5-methyl-1H-imidazol-4-yl)- O
methyl]sulphanyl]ethyl]amino]methylene]urea
N N NH2
HN HCl
52568-80-6 25mg S
N N 2
H H
0025 Dihydrochloride
(Cimetidine Amide Dihydrochloride)
Impurity D (EP) as Dihydrochloride:
1-Methyl-3-[2-[[(5-methyl-1H-imidazol-4- HN
N
S
N
NH
N
HCl
MM0020.06 59660-24-1 100mg
yl)methyl]sulphanyl]ethyl]guanidine H H 2
Dihydrochloride
Impurity D (EP) as Dihydrochloride:
MM0020.06- 1-Methyl-3-[2-[[(5-methyl-1H-imidazol-4- HN
N
S
N
NH
N
HCl
59660-24-1 25mg
yl)methyl]sulphanyl]ethyl]guanidine H H 2
0025
Dihydrochloride
Impurity E (EP): 2-Cyano-1-methyl-3-[2-[[(5- N
methyl-1H-imidazol-4-yl)methyl]sulphinyl]- HN
N O
S
N
MM0020.04 54237-72-8 100mg
ethyl]guanidine N
H
N
H
(Cimetidine Sulphoxide)
Impurity E (EP): 2-Cyano-1-methyl-3-[2-[[(5- N
MM0020.04- methyl-1H-imidazol-4-yl)methyl]sulphinyl]- HN
N O
S
N
54237-72-8 25mg
0025 ethyl]guanidine N
H
N
H
(Cimetidine Sulphoxide)
N
N
MM0020.15 Impurity G (EP): 2-Cyano-1,3-dimethylguanidine 31857-31-5 100mg
N N
H H
MM0020.15- N
Impurity G (EP): 2-Cyano-1,3-dimethylguanidine 31857-31-5 25mg
0025
N N
H H
N
N
MM0020.07 74886-59-2 100mg
bis(2-cyano-3-methylguanidine)
H H
N
N
N
74886-59-2 25mg
0025 bis(2-cyano-3-methylguanidine) N
N
H H
N
MM0020.11- Impurity I (EP) as Hydrochloride: (5-Methyl-1H-imidazol-4-yl) HN
OH HCl
38585-62-5 25mg
0025 methanol Hydrochloride
Impurity J (EP) as Dihydrobromide: 2-[[(5-Methyl- N
HN
MM0020.50 1H-imidazol-4-yl)methyl]sulphanyl]ethanamine 38603-73-5 100mg S
NH2 HBr
2
Dihydrobromide
H
N N
MM0020.10 1,1-Dimethyl-3-cyanoguanidine 1609-06-9 100mg
N
NH
H
MM0020.10- N N
1,1-Dimethyl-3-cyanoguanidine 1609-06-9 25mg
0025 N
NH
N
3-Cyano-2-ethyl-1-[2-[[(5-methyl-1H-imidazol-4-yl)methyl] N N
HN
MM0020.19 75850-09-8 100mg S
N O
sulphanyl]ethyl]isourea H
N
MM0020.19- 3-Cyano-2-ethyl-1-[2-[[(5-methyl-1H-imidazol-4-yl)methyl] N N
HN
75850-09-8 25mg S
N O
0025 H
sulphanyl]ethyl]isourea
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-131
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
H
H 2N N
MM0056.01 Cyanoguanidine 461-58-5 100mg N
NH
H
MM0056.01- H 2N N
Cyanoguanidine 461-58-5 25mg N
0025 NH
Cinacalcet Hydrochloride
F F
N F
O F F
MM3370.01- N-[(1R)-1-(1-naphthyl)ethyl]-3-[3-(trifluoromethyl)phenyl] N F
H
1005450-55-4 25mg
0025 propanamide
O F F
HO F
MM3370.02 3-[3-(Trifluoromethyl)phenyl]propanoic Acid 585-50-2 100mg
O F F
HO F
MM3370.03 3-(Trifluoromethyl)cinnamic Acid 779-89-5 100mg
O F F
MM3370.03- HO F
3-(Trifluoromethyl)cinnamic Acid 779-89-5 25mg
0025
MM3370.05- HCl
(1R)-1-(1-Naphthyl)ethylamine Hydrochloride 82572-04-1 25mg NH2
0025
(S)-Cinacalcet Hydrochloride F F
MM3370.06- N
H
F
HCl
Related compound D (USP): (S)-N-[1-(Naphthalen-1-yl) 1217809-88-5 25mg
0025
ethyl]-3-[3-(trifluoromethyl)phenyl]propan-1-amine
MM3370.07- N
H HCl
(R)-N-Benzyl-1-(naphthalen-1-yl)ethanamine Hydrochloride 163831-65-0 25mg
0025
F F
MM3370.08- 3-[3-(Trifluoromethyl)phenyl]propanol HO F
78573-45-2 100mg
0100 Related compound E (USP): USP monograph in draft
87864-14-0 25mg N
0025 4-carboxamide
O
HO
OH
Impurity B (EP): 2-Hydroxyquinoline-4-
MM0604.02 15733-89-8 100mg N
carboxylic Acid
O
HO
OH
MM0604.02- Impurity B (EP): 2-Hydroxyquinoline-4-
15733-89-8 25mg N
0025 carboxylic Acid
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-132
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
O
O
OH
O
O
MM0604.04- OH
O
HO
O
MM0604.07 2-Hydroxy-4-quinolinecarboxylic Acid Methyl Ester 84906-82-1 100mg N
O
HO
MM0604.07- O
2-Hydroxy-4-quinolinecarboxylic Acid Methyl Ester 84906-82-1 25mg N
0025
Cineole (Eucalyptol)
O
MM1763.00 Cineole 470-82-6 250mg
Cinnamedrine Hydrochloride
OH
Cinnarizine
N
N
NH
N
NH
N
MM1038.01-
Impurity A (EP): 1-(Diphenylmethyl)piperazine 841-77-0 25mg
0025
+
N
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-133
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
N
MM1038.06 Impurity E (EP): 1,4-Bis(diphenylmethyl)piperazine 216581-01-0 100mg N
MM1038.06- N
Impurity E (EP): 1,4-Bis(diphenylmethyl)piperazine 216581-01-0 25mg N
0025
O
+
N
MM1038.11- HCl
N 2
Cinoxacin
O O
O
OH
MM1991.00 Cinoxacin 28657-80-9 100mg O N
N
Ciprofibrate
O
O
OH
MM1141.00 Ciprofibrate 52214-84-3 250mg Cl
Cl
Ciprofloxacin Hydrochloride
HN
MM0018.00- N N
Ciprofloxacin 85721-33-1 250mg OH
0250 F
O O
HN
Ciprofloxacin Hydrochloride N N
MM0018.06
Monohydrate
86393-32-0 500mg HCl
OH
F
H2 O
O O
(Ethylenediamine Compound)
Impurity C (EP) as Hydrochloride: 7-[(2-Aminoethyl)amino]-1-
H
MM0018.12- cyclopropyl-6-fluoro-4-oxo-1,4-dihydroquinoline-3-carboxylic H 2N
N N
HCl
528851-31-2 25mg F
OH
0025 Acid Hydrochloride (Ethylenediamine Compound O O
Hydrochloride)
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-134
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
6-(piperazin-1-yl)-1,4-dihydroquinoline-3-carboxylic acid
HN
Impurity E (EP): 1-Cyclopropyl-6-fluoro-7- N N
MM0018.03 (piperazin-1-yl)-quinolin-4(1H)-one 105394-83-0 100mg
(Decarboxylated Compound) F
O
HN
6-(2-Aminoethylamino)-7-chloro-1- Cl N
MM0018.10- 6-(2-Aminoethylamino)-7-chloro-1- Cl N
MM0018.13- 1-Cyclopropyl-6-fluoro-4-oxo-7-(3-oxopiperazin- HN
OH
0025 (Oxociprofloxacin) F
O O
O N
MM0018.16- N N
HN
MM0018.17- N N
HN
MM0018.18- N N
HN
MM0018.19- N N
Citalopram Hydrobromide
F
HBr
(4-fluorophenyl)-1,3-dihydroisobenzofuran-5-carboxamide
Impurity B (EP) as Oxalate: 1-[3-(Dimethylamino)propyl]-1-(4-
fluorophenyl)-3-hydroxy-1,3-dihydroisobenzofuran-5- F
MM0242.21- O OH
carbonitrile Oxalate (3-Hydroxycitalopram Oxalate)
1332724-03-4 25mg O
N O OH
0025 Related compound B (USP): 1-[3-(dimethylamino)propyl]-1- N OH
(4-fluorophenyl)-3-hydroxy-1,3-dihydroisobenzofuran-5-
carbonitrile
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-135
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
F
Impurity C (EP): (3RS)-6-Cyano-3-[3-(dimethyl-
amino)propyl]-3-(4-fluorophenyl)isobenzofuran-
1(3H)-one
MM0242.17 372941-54-3 100mg N
O
F
Impurity C (EP): (3RS)-6-Cyano-3-[3-(dimethyl-
MM0242.17- amino)propyl]-3-(4-fluorophenyl)isobenzofuran-
1(3H)-one
372941-54-3 25mg N
0025 O
MM0242.20- (dimethylamino)propyl]-3-(4-fluorophenyl)isobenzofuran-1 O OH
1440961-11-4 25mg N
methylaminopropyl)-1,3-dihydroisobenzofuran-5-carbonitrile
Impurity E (EP) as Oxalate: 3-[(1RS)-5-Chloro-1-
F
(4-fluorophenyl)-1,3-dihydroisobenzofuran-1- HO O
dimethylaminopropyl)-5-chlorophthalane
Impurity F (EP) as Hydrobromide: 3-[(1RS)-5-Bromo-1-(4- F
fluorophenyl)-1,3-dihydroisobenzofuran-1-yl]-N,N- HBr
MM0242.04-
dimethylpropan-1-amine Hydrobromide 479065-02-6 25mg
0025 N
O
Related compound H (USP): 1-(4'-fluorophenyl)-1-(3- Br
dimethylaminopropyl)-5-bromophthalane
HO O
MM0242.13-
dimethylpropan-1-amine Hydrogen Oxalate 64372-43-6 25mg N HO O
0025 O
Br
Citalopram N-Oxide
Related compound E (USP) +
MM0242.10 63284-72-0 100mg N
O O
MM0242.23-
5-Cyanophthalide 82104-74-3 25mg O
0025
N
MM0242.29-
1-(4-Fluorophenyl)-1,3-dihydroisobenzofuran-5-carbonitrile 64169-67-1 25mg
0025
O
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-136
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
MM0242.31- 1-(4-Fluorophenyl)-3-oxo-1,3-dihydroisobenzofuran-5-
372941-46-3 25mg
0025 carboxamide O
H 2N
O O
Citicoline Sodium
O N NH2
O O O O
MM3913.00- N
+
O
P
O
P
O
O
N
HO OH
0250
Cladribine
NH2
N
N
Cl N N
MM3381.00 Cladribine 4291-63-8 250mg
O
OH
HO
NH2
H
Impurity C (EP): 2-Chloro-7H-purin-6-amine (2- N
N
MM3381.01 1839-18-5 100mg
Chloroadenine)
Cl N N
NH2
H
MM3381.01- Impurity C (EP): 2-Chloro-7H-purin-6-amine (2- N
N
1839-18-5 25mg
0025 Chloroadenine)
Cl N N
O
MM0344.12- O
Impurity G (EP): Methyl 4-Methylbenzoate 99-75-2 100mg
0100
Clarithromycin
O
OH
O HO
O
O
MM0057.00- O
Clarithromycin 81103-11-9 250mg OH O O
0250 N
O
HO O
OH
MM0057.05- O
Related compound A (USP): 6,11-di-O-methylerythromycin 81103-14-2 25mg OH O O
N
A
0025 O
HO O
OH
O HO
O
O
MM0057.17- O
Clarithromycin N-Oxide 118074-07-0 25mg O N+
OH O O
0025 O
HO O
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-137
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
OH
O HO HO
O O
MM0132.13 N-Demethylerythromycin A 992-62-1 100mg N
H
OH O O
O
HO
O
OH
O HO HO
MM0132.13- O O
N-Demethylerythromycin A 992-62-1 25mg N
H
OH O O
0025 O
HO
O
Clebopride Malate
O
O N HO
H 2N O
N
H HO
O
OH
Clemastine Fumarate
O N
Cl
Clenbuterol Hydrochloride
OH
H
Cl N
Clidinium Bromide
OH
O +
N
HO
3-Hydroxy-1-methylquinuclindinium Bromide
MM1798.01-
Related compound A (USP): 3-Hydroxy-1- 2096336-00-2 25mg + Br
0025 N
methylquinuclindinium
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-138
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
Clindamycin Hydrochloride
Cl
H
N N
MM0259.00- O S
H
Clindamycin Hydrochloride 21462-39-5 250mg O
0250 HO OH
HCl OH
HCl H2O
O H O
MM0320.00 carbonyl]amino]-1-thio-D-erythro- -D-galacto-octopyranoside 7179-49-9 250mg HO S
HO OH
Hydrochloride Monohydrate (Lincomycin Hydrochloride
Monohydrate)
N Cl
H
N
H
O O
O S
MM0259.07 Triacetylclindamycin n/a 100mg O
O O
O
O
N Cl
H
N
H
MM0259.07- O O
O S
Triacetylclindamycin n/a 25mg O
0025 O O
O
O
OH
H
Cl OH
O
O H
N O
MM1989.08- N
H
O
S
O
0050
Clindamycin Phosphate
Cl
H
N N
O S
HCl H2O
O H O
MM0320.00 carbonyl]amino]-1-thio-D-erythro- -D-galacto-octopyranoside 7179-49-9 250mg HO S
HO OH
Hydrochloride Monohydrate (Lincomycin Hydrochloride
Monohydrate)
N Cl
H
N
O O O
MM1520.02 Clindamycin Phosphate Sulfoxide 1228573-90-7 100mg HO S
O
HO O P
OH
OH
N Cl
H
N
MM1520.02- O O O
Clindamycin Phosphate Sulfoxide 1228573-90-7 25mg HO S
0025 O
HO O P
OH
OH
N Cl
H
N
O O O
O
MM1520.03 Clindamycin Phosphate Sulfone n/a 100mg HO S
O
HO O P
OH
OH
N Cl
H
N
MM1520.03- O O O
O
Clindamycin Phosphate Sulfone n/a 25mg HO S
O
0025 HO O P
OH
OH
O
+
N Cl
H
N
MM1520.04- O O O
Clindamycin Phosphate Sulfoxide trans-N-Oxide n/a 25mg HO S
0025 O
HO O P
OH
OH
Cl
O O
O
O S
MM1520.05- +
N
H
Clindamycin Phosphate Sulfone trans-N-Oxide n/a 25mg N
HO O
O
0025 OH P OH
O OH
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-139
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
N Cl
H
N
O O
O S
MM1520.07 Diacetylclindamycin Phosphate n/a 100mg O O
O O P
OH
OH
O
N Cl
H
N
MM1520.07- O O
O S
Diacetylclindamycin Phosphate n/a 25mg O O
0025 O O P
OH
OH
O
Clioquinol
OH
I N
Cl
OH
N
Cl
OH
Cl N
Cl
OH
Cl N
MM0312.02-
Impurity B (EP): 5,7-Dichloroquinolin-8-ol 773-76-2 25mg
0025
Cl
OH
I N
MM0312.03-
Impurity C (EP): 5,7-Diiodoquinolin-8-ol (Iodoquinol) 83-73-8 25mg
0025
I
Clobazam
O
N
MM0910.00-
Clobazam 22316-47-8 CS 250mg Cl N
0250 O
H O
N
Impurity A (EP): 7-Chloro-5-phenyl-1,5-dihydro-
3H-1,5-benzodiazepine-2,4-dione Cl N
MM0910.01
(Norclobazam)
22316-55-8 100mg O
H O
N
Impurity A (EP): 7-Chloro-5-phenyl-1,5-dihydro-
MM0910.01- 3H-1,5-benzodiazepine-2,4-dione Cl N
(Norclobazam)
22316-55-8 25mg O
0025
Related compound A (USP)
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-140
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
Clobenzorex Hydrochloride
MM0649.00- H
Cl
HCl
0250
Clobetasol Propionate
Cl
O O
HO O
MM0769.00 Clobetasol Propionate 25122-46-7 100mg H
F H
O
OH
MM0769.10- Impurity F (EP): 9-Fluoro-11 -hydroxy-16 -methyl-3- HO
2412496-00-3 25mg H
F H
3,20-dione (Clobetasol) O
Propionate) O
Propionate) O
OH
HO
MM0200.11- 9-Fluoro-11 ,21-dihydroxy-16-methylpregna-1,4,16-triene- H
59860-99-0 25mg
0025 3,20-dione F H
O
O
HO O
MM0213.20- H
Dexamethasone Oxetanone 4089-36-5 25mg
0025 F H
O
Clobetasone Butyrate
Cl
O O
O O
F H
O
Clobutinol Hydrochloride
N
Cl
N
MM0038.01 1-Dimethylamino-2-methylbutan-3-one 22104-62-7 100mg
O
Clocortolone Pivalate
O O
HO O
H
MM3743.00 Clocortolone Pivalate 34097-16-0 250mg Cl H
O
F
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-141
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
Clofarabine
N H2
N
N
Cl N N
F
MM3521.00 Clofarabine 123318-82-1 250mg
O
OH
OH
Clofazimine
N
N Cl
Clofibrate
O
O
MM1934.00 Clofibrate 637-07-0 250mg O
Cl
O
MM1934.01- O
O
Methyl 2-(4-Chlorophenoxy)-2-methylpropionate 55162-41-9 100mg
0100 Cl
Clomethiazole Edisylate
Cl
O O
O
S
O
OH
N
2
N
MM0049.02 5-(2-Hydroxyethyl)-4-methylthiazole 137-00-8 100mg
S OH
OH
O
phenoxy]-N,N-diethylethanamine
O
N
O +
N
O
HCl
O
N
H
HCl
O
N
MM0650.03- H
0025 HCl
O
N
OH
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-142
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
O
N
OH
MM0650.10-
1-[4-[2-(Diethylamino)ethoxy]phenyl]-1,2-diphenylethanol 73404-00-9 25mg
0025
Clomipramine Hydrochloride
Cl
HCl
N
MM0545.00 Clomipramine Hydrochloride 17321-77-6 500mg N
MM0545.03- dibenzo[b,f]azepin-5-yl)-N,N-dimethylpropan-
HCl
1-amine Hydrochloride n/a 25mg N N
MM0545.04- 10,11-dihydro-5H-dibenzo[b,f]azepin-5-yl)-N,N-
HCl
dimethylpropan-1-amine Hydrochloride 115189-28-1 25mg N N
5H-dibenzo[b,f]azepin-5-yl)-N,N-dimethylpropan-1-amine
Cl
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-143
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
Cl
Cl
Cl
HCl
MM0545.08 Desmethylclomipramine Hydrochloride 29854-14-6 100mg N N
H
Cl
MM0545.08- HCl
Desmethylclomipramine Hydrochloride 29854-14-6 25mg N N
H
0025
Cl
Cl
MM0545.09-
Clomipramine N-Oxide 14171-67-6 25mg N N
+
O
0025
Cl
3-Chloro-10-[3-(dimethylamino)propyl]- N N
9-acridanone
MM0545.13 1783028-21-6 100mg
O
Cl
MM0545.13- 3-Chloro-10-[3-(dimethylamino)propyl]- N N
9-acridanone
1783028-21-6 25mg
0025 O
Clonazepam
H O
N
MM0945.00- O +
N
Clonazepam 1622-61-3 CS 250mg N
0250 O
Cl
NH2
Impurity A (EP): (2-Amino-5-nitrophenyl)(2-
O O
chlorophenyl)methanone N
+
nitrobenzophenone
NH2
Impurity A (EP): (2-Amino-5-nitrophenyl)(2-
O O
MM0945.01- chlorophenyl)methanone N
+
MM0945.02- 6-nitroquinolin-2(1H)-one O
N
+
NH2
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-144
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
O
N
O +
MM0945.04 Methylclonazepam 5527-71-9 50mg N N
O
Cl
O
Br
NH
2-Bromo-2'-(2-chlorobenzoyl)-4'-nitroacetanilide
O O
MM0945.05 Related compound C (USP): 2-bromo-2'-(2-chlorobenzoyl)- 52130-87-7 50mg N
+
4'-nitroacetanilide O Cl
O
NH2
NH
H
N
N
MM0945.08- O +
N
3-(2-Chlorophenyl)-5-nitro-1H-indazole n/a 25mg Cl
0025 O
O + N
MM0945.09- N
4-(2-Chlorophenyl)-6-nitroquinazoline 1647150-35-3 25mg O Cl
0025
O
N
O
MM0945.10- 2-Hydroxypropyl 4-(2-Chlorophenyl)-6-nitroquinazoline-2- O
N
+ N OH
n/a 25mg O Cl
0025 carboxylate
N H2
O
O + N
MM0945.12- 2-[[(2-Amino-5-nitrophenyl)(2-chlorophenyl)methylene]amino] N O
n/a 25mg O Cl
Clonidine Hydrochloride
Cl
HN
MM0983.00-
Clonidine Hydrochloride 4205-91-8 250mg N N
H
HCl
0250 Cl
HN
HN
MM0983.04- N
Impurity A (EP): 1-Acetylimidazolidin-2-one 5391-39-9 25mg O
0025
O
Cl
N
MM0983.03- Impurity B (EP): 1-Acetyl-2-[(2,6-dichloro-
54707-71-0 25mg N N
0025 phenyl)amino]-4,5-dihydro-1H-imidazole Cl
H
O
N H2
Cl Cl
MM0006.21 Impurity C (EP): 2,6-Dichloroaniline 608-31-1 100mg
N H2
MM0006.21- Cl Cl
Impurity C (EP): 2,6-Dichloroaniline 608-31-1 25mg
0025
Cl
S
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-145
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
Cl
S
MM0983.02-
1-(2,6-Dichlorophenyl)thiourea 6590-91-6 25mg N NH2
0025 H
Cl
Clopamide
O
Cl
O
MM0063.03- OH
Impurity B (EP): 4-Chlorobenzoic Acid 74-11-3 25mg
0025
Cl
O O O
S
H 2N OH
MM0477.04 Impurity C (EP): 4-Chloro-3-sulfamoylbenzoic Acid 1205-30-7 100mg
Cl
O O O
MM0477.04- S
H 2N OH
Impurity C (EP): 4-Chloro-3-sulfamoylbenzoic Acid 1205-30-7 25mg
0025 Cl
MM0455.10- O
Cl
Clopidogrel Hydrogen Sulfate 120202-66-6 250mg N
O
HO S
O
OH
0250 S
O
0025 Sulfate S
N
O
O
Cl
MM0455.09 Clopidogrel Alcohol 1227294-01-0 100mg OH
N
MM0455.09- Cl
Clopidogrel Alcohol 1227294-01-0 25mg OH
0025 N
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-146
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
MM0455.20- N H2
2-(Thiophen-2-yl)ethylamine 30433-91-1 100mg
0100 S
MM0455.21- Cl
2-Amino-2-(2-chlorophenyl)acetic Acid 88744-36-9 25mg
0025 OH
H 2N
O
MM0455.23- NH
4,5,6,7-Tetrahydrothieno[3,2-c]pyridine Hydrochloride 28783-41-7 25mg HCl
0025 S
O OH
MM0455.24- Cl
HO
OH
Methyl (2S)-2-Amino-2-(2-chlorophenyl)acetate Tartrate 141109-15-1 25mg H2 N
O
OH O
0025 O
S
MM0150.00- N HCl
Ticlopidine Hydrochloride 53885-35-1 250mg
0250 Cl
S
MM0150.06- HN
6,7-Dihydrothieno[3,2-c]-pyridin-4(5H)-one 68559-60-4 25mg
0025
O
MM0455.27- Cl
Methyl 2-Chloro-2-(2-chlorophenyl)acetate 90055-47-3 100mg
0100 O
Cl
O
Clopidol
Cl
N
MM0699.00 Clopidol 2971-90-6 250mg
HO
Cl
Cl
N
MM0699.01 3,5-Dichloro-2,6-dimethylpyridin-4-amine 50978-40-0 100mg
H 2N
Cl
Cl
MM0699.01- N
3,5-Dichloro-2,6-dimethylpyridin-4-amine 50978-40-0 25mg
0025 H 2N
Cl
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-147
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
Clorgyline Hydrochloride
Cl
Clorindione
O
Clorprenaline Hydrochloride
OH
H
N
MM0716.02 Clorprenaline Hydrochloride 6933-90-0 250mg HCl
Cl
Clorsulon
O O O O
S S
H 2N N H2
Cl Cl
Clostebol Acetate
O
H
MM3725.00 Clostebol Acetate 855-19-6 250mg
H H
O
Cl
Clotrimazole
MM0015.00-
Clotrimazole 23593-75-1 250mg
0250 Cl N
diphenylmethanol
diphenylmethanol
Cl
Cl
H
N
MM0015.02 Impurity D (EP): Imidazole 288-32-4 100mg
N
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-148
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
O Cl
Impurity E (EP): (2-Chlorophenyl)phenyl-
MM0015.06 5162-03-8 100mg
methanone (2-Chlorobenzophenone)
O Cl
MM0015.06- Impurity E (EP): (2-Chlorophenyl)phenyl-
5162-03-8 25mg
0025 methanone (2-Chlorobenzophenone)
MM0015.04-
(2-Chlorophenyl)diphenylmethane 56153-60-7 25mg Cl
0025
(2-Chlorophenyl)diphenylmethyl Ethyl
MM0015.05
Ether
717109-43-8 100mg
Cl O
(2-Chlorophenyl)phenyldichloro-
methane
MM0015.07 3509-85-1 100mg
Cl Cl Cl
Cl Cl Cl
MM0015.09- 1-[(2-Chlorophenyl)diphenylmethyl]-1H-
pyrazole
289905-88-0 25mg
0025 Cl N
N
Cloxacillin Sodium
Cl O +
O Na
O
S
H2 O
H
O
O
OH
Impurity C (EP): (2S,5R,6R)-6-Amino-3,3-dimethyl- O
MM0026.04 7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2- 551-16-6 100mg N
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-149
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
O
OH
MM0026.04- Impurity C (EP): (2S,5R,6R)-6-Amino-3,3-dimethyl- O
7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2- 551-16-6 25mg N
0025 carboxylic Acid (6-Aminopenicillanic Acid) H 2N S
H
Cl
Impurity D (EP): 3-(2-Chlorophenyl)-5-methyl-
isoxazole-4-carboxylic Acid N
Related compound D (USP): 3-(2-Chlorophenyl)-5-
MM0682.04 23598-72-3 100mg
O OH
methylisoxazole-4-carboxylic acid
O
Cl
Impurity D (EP): 3-(2-Chlorophenyl)-5-methyl-
MM0682.04- isoxazole-4-carboxylic Acid N
Related compound D (USP): 3-(2-Chlorophenyl)-5-
23598-72-3 25mg
0025 O OH
methylisoxazole-4-carboxylic acid
O
Cloxiquine
OH
N
Cl
Clozapine
Cl N
N N
MM0480.00-
Clozapine 5786-21-0 250mg
0250 N
H
Cl
H
N O
Impurity A (EP): 8-Chloro-5,10-dihydro-11H-
MM0480.01 50892-62-1 100mg
dibenzo[b,e][1,4]diazepin-11-one N
H
Cl
H
N O
MM0480.01- Impurity A (EP): 8-Chloro-5,10-dihydro-11H-
50892-62-1 25mg
0025 dibenzo[b,e][1,4]diazepin-11-one N
H
H
N
dibenzo[b,e][1,4]-diazepine) N
H
Cl NH
Cl NH
6104-71-8 25mg
0025 yl)-5H-dibenzo[b,e][1,4]diazepine N
H
Cl N H2
Cl +
N O
N N
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-150
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
Cobicistat
N
S
O
MM3623.01- Thiazol-5-ylmethyl N-((2R,5R)-5-Amino-1,6-diphenylhexan-2- H2 N HCl
N O
1247119-33-0 25mg H
0025 yl)carbamate Hydrochloride
MM3623.02- H 2N HCl
(2R,5R)-1,6-Diphenylhexane-2,5-diamine Dihydrochloride 1247119-31-8 25mg NH2
2
0025
O
+
N
O O
MM1034.23 4-Nitrophenyl Thiazol-5-ylmethyl Carbonate 144163-97-3 100mg O O
S
O
+
N
MM1034.23- O O
4-Nitrophenyl Thiazol-5-ylmethyl Carbonate 144163-97-3 25mg S
O O
0025 N
Cocaine Hydrochloride
N H O
O HCl
MM1345.00-
Cocaine Hydrochloride 53-21-4 CS 250mg H O
0250
O
N H O
OH HCl
MM1345.02 Ecgonine Hydrochloride 5796-31-6 CS 100mg
H OH
N H O
MM1345.02- OH HCl
Ecgonine Hydrochloride 5796-31-6 CS 25mg
0025 H OH
N H O
OH
MM1345.04-
Benzoylecgonine 519-09-5 CS 25mg H O
0025
O
N H O
MM1345.08- O
Ecgonine Ethyl Ester 70939-97-8 CS 100mg
0100
H OH
Codeine Monohydrate
N
O O OH
N
OH
HO
O O OH
2
O O OH
N
Impurity A (EP): 7,8-Didehydro-4,5 -epoxy-
H
MM0004.03 3,6 -dimethoxy-17-methylmorphinan 2859-16-7 CS 100mg
(O-Methylcodeine) O
O O
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-151
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
hydrate HO O OH
2
MM0037.02- H
HO N
Impurity E (EP) as -Isomer: 7,8-Didehydro-4,5 -epoxy-3-
MM0004.22- H
methoxy-17-methylmorphinan-6 ,10 -diol (10 - 16589-96-1 25mg
0025
Hydroxycodeine) O
O OH
N
Impurity F (EP): 7,8-Didehydro-4,5 -epoxy-3-
HO
MM0004.12 methoxy-17-methylmorphinan-6 ,14-diol 4829-46-3 100mg
(14-Hydroxycodeine)
O O OH
H
N
H
N
O
+
N
O O OH
N
Impurity K (EP): 4,5 -Epoxy-14-hydroxy-3-methoxy-17-
MM0672.04- HO
methyl-7,8-didehydromorphinan-6-one (14- 508-54-3 25mg
0025
Hydroxycodeinone) O
O O
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-152
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
N
MM0004.04- H
Codeimethine 23950-06-3 25mg
0025
O O OH
H
MM0004.06 Acetylcodeine 6703-27-1 CS 100mg
O
O O O
MM0004.06- H
Acetylcodeine 6703-27-1 CS 25mg
0025 O
O O O
N
OH
O O
N
OH
MM0004.07-
Pseudocodeine 466-96-6 25mg H
0025
O O
O O OH
MM0004.08-
Isocodeine 509-64-8 CS 25mg H
0025
O O OH
N
HO O OH
H
N
HO O OH
MM0037.01- H
Colchicine
O
H
N
O
MM1083.00 Colchicine 64-86-8 100mg O
O
O
Impurity C (EP): N-[(7S,7bR,10aS)-1,2,3,9-Tetramethoxy-8- H
N
MM1083.03- oxo-5,6,7,7b,8,10a-hexahydrobenzo[a]cyclopenta[3,4] O
O
H
O
6901-13-9 25mg H
0025 cyclobuta[1,2-c]cyclohepten-7-yl]acetamide ( - O
Lumicolchicine) O
HO
O
benzo[a]heptalen-7-yl]acetamide (Colchicoside)
O
HO
H
Impurity E (EP): N-[(7S,12aRa)-3-Hydroxy-1,2,10-trimethoxy- O
N
O
O-Demethylcolchicine) O
O
H
Impurity F (EP): N-[(7S,12aRa)-10-Hydroxy-1,2,3-trimethoxy- O
N
O
(Colchiceine) OH
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-153
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
Conivaptan Hydrochloride
O
N
H
N
N
H
N HCl
Cortisone
O
OH
O OH
H H
O
Cortisone Acetate
O
O
O
MM0186.00- O OH
Cortisone Acetate 50-04-4 250mg H
0250 H H
O
O
O
O
MM0187.00- HO OH
Impurity A (EP): Hydrocortisone Acetate 50-03-3 250mg H
0250 H H
O
O
OH
HO O
MM0187.01- H
Hydrocortisone 17-Acetate 16463-74-4 25mg O
0025 H H
O
Coumatetralyl
OH
Creatine Monohydrate
O
N NH2
MM3357.01 Creatine 57-00-1 250mg HO
NH
Crizotinib
N NH2
O Cl
MM3930.00- HN N
Crizotinib 877399-52-5 250mg N
0250 Cl
F
Cyanocobalamin
H2 N
H 2N
O
O
H2 N
O
H
O NH H H
O O H (IV)N
P C
O (IV)
N
O OH N
O H 2N
NH2
N
MM1449.01-
5,6-Dimethylbenzimidazole 582-60-5 25mg
0025 N
H
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-154
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
Cyclandelate
OH
O
Cyclizine Hydrochloride
N
N
OH
OH
MM0490.02-
Impurity B (EP): Diphenylmethanol (Benzhydrol) 91-01-0 25mg
0025
O
+
N
N
HCl
MM1265.04 Cyclizine N-Oxide Dihydrochloride n/a 100mg 2
O
+
N
MM1265.04- N
HCl
Cyclizine N-Oxide Dihydrochloride n/a 25mg 2
0025
Cyclobenzaprine Hydrochloride
HCl
MM0062.02- N
Cyclobenzaprine Hydrochloride 6202-23-9 250mg
0250
5-[3-(Dimethylamino)propyl]-5H-dibenzo[a,d]cyclohepten-5-ol OH
N
MM1248.01 Related compound A (USP): 5-[3-(dimethylamino)propyl]-5H- 18029-54-4 50mg
dibenzo[a,d]-cyclohepten-5-ol
+
N HCl
MM1248.03 Cyclobenzaprine N-Oxide Hydrochloride n/a 100mg O
Cyclofenil
O O
Cycloguanil Embonate
Cl
N N
H2 N N NH2
2
MM3025.00 Cycloguanil Embonate 609-78-9 50mg O OH OH O
HO OH
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-155
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
OH
OH
HO
H
H 2N N
MM0056.01 Cyanoguanidine 461-58-5 100mg N
NH
H
MM0056.01- H 2N N
Cyanoguanidine 461-58-5 25mg N
0025 NH
Cycloguanil Hydrochloride
Cl
H 2N N N H2
H
H 2N N
MM0056.01 Cyanoguanidine 461-58-5 100mg N
NH
H
MM0056.01- H 2N N
Cyanoguanidine 461-58-5 25mg N
0025 NH
Cyclopentobarbital
H
O N O
NH
MM1579.00 Cyclopentobarbital 76-68-6 50mg
O
Cyclopentolate Hydrochloride
O
N
O
MM0160.03 Impurity B (EP): Phenylacetic Acid 103-82-2 100mg
OH
MM0160.03- O
Impurity B (EP): Phenylacetic Acid 103-82-2 25mg
0025 OH
O O
+
N
O HCl
MM0580.05 Cyclopentolate N-Oxide Hydrochloride n/a 100mg HO
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-156
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
O O
+
MM0580.05- N
O HCl
Cyclopentolate N-Oxide Hydrochloride n/a 25mg HO
0025
Cyclophosphamide
Cl
O
O
MM0822.00 Cyclophosphamide Monohydrate 6055-19-2 250mg P
NH
N H2 O
Cl
O
O
Impurity F (EP): 3-Aminopropyl Dihydrogen Phosphate P OH
MM0822.03-
Related compound C (USP): 3-aminopropyl dihydrogen 1071-28-9 25mg OH
0025 phosphate
NH2
Cycloserine
O
Cyclothiazide
O O O O
S S
H2 N NH
Cynarine
O
MM0048.01- HO
3,4-Dihydroxycinnamic Acid (Caffeic Acid) 331-39-5 250mg OH
0250 HO
Cyproheptadine Hydrochloride
N
H2 O
Cyproheptadine Hydrochloride 3
MM0609.00
Sesquihydrate
41354-29-4 500mg HCl
2
2
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-157
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
HCl
MM0609.07 ol Hydrochloride 4046-24-6 50mg
Related compound C (USP): 5-(1-methyl-piperidin-4-yl)-5H-
dibenzo[a,d]cyclohepten-5-ol
O
5H-Dibenzo[a,d]cyclohepten-5-one
MM0609.02
(Dibenzosuberenone)
2222-33-5 100mg
O
MM0609.02- 5H-Dibenzo[a,d]cyclohepten-5-one
(Dibenzosuberenone)
2222-33-5 25mg
0025
NH
MM0609.04- HCl
Demethylcyproheptadine Hydrochloride 4331-45-7 25mg
0025
+
N
O
+
N
O
+
N
O
MM0609.06-
Cyproheptadine -N-Oxide 60251-34-5 25mg
0025 beta-Isomer
Cyproterone Acetate
O
O
H
MM0215.00 Cyproterone Acetate 427-51-0 250mg H H
O
O
Cl
Acetate) O
Cl
0025 Acetate) O
Cl
Cytarabine
OH
HO
H 2N N O
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-158
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
HN
HO OH
HN
HO OH
HN
O HO H
HN
O HO H
NH2
MM0749.05- N
Impurity C (EP): 4-Aminopyrimidin-2(1H)-one (Cytosine) 71-30-7 25mg
0025
O N
H
MM0593.03- HN
Impurity D (EP): Pyrimidin-2,4(1H,3H)-dione (Uracil) 66-22-8 25mg
0025
O N
H
N H2
HO OH
DDT
Cl
Cl
MM2513.01-
2,2-Bis(4-chlorophenyl)-1-chloroethane 2642-80-0 25mg
0025 Cl Cl
Cl
MM2513.02 1-Chloro-3-[1-(4-chlorophenyl)ethyl]benzene 77008-64-1 100mg
Cl
MM2513.05-
1,1-Bis(4-chlorophenyl)ethane 3547-04-4 25mg
0025 Cl Cl
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-159
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
O
Ethyl 3-[[3-Amino-4-(methylamino)benzoyl]-(2-pyridyl)amino] NH2
N N
MM3522.01 propanoate (N-[3-Amino-4-(methylamino)benzoyl]-N-2- 212322-56-0 100mg NH
O
Ethyl 3-[[3-Amino-4-(methylamino)benzoyl]-(2-pyridyl)amino] NH2
MM3522.01- N N
propanoate (N-[3-Amino-4-(methylamino)benzoyl]-N-2- 212322-56-0 25mg NH
0025
pyridinyl- -alanine Ethyl Ester) O O
O
NH
H
MM3522.02- N N
N N
N H2
Dabigatran 211914-51-1 25mg N
0025 O OH
H
1408238-40-3 25mg N O
O O
0025 methylbenzimidazole-5-carbonyl]-(2-pyridyl)amino]
propanoate)
NH
H2 N O
Hexyl N-(4-Aminobenzenecarboximidoyl)carbamate N
H HCl
MM3522.06 1307233-93-7 100mg O
Hydrochloride
NH
H2 N O
MM3522.06- Hexyl N-(4-Aminobenzenecarboximidoyl)carbamate N
H HCl
1307233-93-7 25mg O
0025 Hydrochloride
O
NH
H
MM3522.08- N N
N N
N
O
H
Desethyldabigatran Etexilate 212321-78-3 25mg N O
O OH
0025
O
H
MM3522.09- Ethyl 3-[[2-[(4-Cyanoanilino)methyl]-1-methylbenzimidazole- N N N
N N
211915-84-3 25mg N
0025 5-carbonyl]-(2-pyridyl)amino]propanoate O O
O O
+
N
MM3522.10- Ethyl 3-[[4-(Methylamino)-3-nitrobenzoyl]-(2-pyridyl)amino] N N O
429659-01-8 25mg NH
0025 propanoate
O O
Dacarbazine
N
HN
N H2
0025 N NH
N
N
Impurity B (EP): 5-Amino-1H-imidazole-4-carboxamide HN
MM1289.02- N H2
Related compound A (USP): 5-aminoimidazole-4- 360-97-4 25mg
carboxamide
0025 H 2N O
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-160
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
carboxamide
Impurity D (EP) as Hydrochloride: N-Methylmethanamine H
MM0056.06 506-59-2 100mg N HCl
Hydrochloride
Daidzein
HO O
HO O
MM0747.02-
(RS)-Equol 94105-90-5 25mg
0025 OH
Dalfampridine
N
MM3462.00 Dalfampridine 504-24-5 100mg
NH2
Danofloxacin Mesilate
O O
F
H OH
Dantrolene Sodium
5-(4-Nitrophenyl)furan-2-carbaldehyde O
O
MM0905.01 Related compound C (USP): (5-(4-nitrophenyl)-2- 7147-77-5 100mg O +
N
O
furancarboxyaldehyde
5-(4-Nitrophenyl)furan-2-carbaldehyde O
MM0905.01- O
Related compound C (USP): (5-(4-nitrophenyl)-2- 7147-77-5 25mg O +
N
0025 O
furancarboxyaldehyde
5-(4-Nitrophenyl)-2-furaldehyde Azine O
N
+
O
N
+
O
O
methylenehydrazine N
H2 O
Cl
HO OH
OH
OH
Cl
OH
MM3611.04 Dapagliflozin 461432-26-8 100mg O
HO OH
OH
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-161
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
Br
MM3611.01-
4-Bromo-1-chloro-2-(4-ethoxybenzyl)benzene 461432-23-5 25mg Cl
0025
Br
O
MM3611.02 Triacetoxy-6-[4-chloro-3-(4-ethoxybenzyl)phenyl] 461432-25-7 100mg
O O O
tetrahydropyran-2-yl]methyl Acetate) O
O
O
tetrahydropyran-2-yl]methyl Acetate) O
O
O
MM3611.03- (2S,3R,4S,5S,6R)-2-[4-Chloro-3-(4-ethoxybenzyl)phenyl]-6- Cl
OH
714269-57-5 25mg O
O
0025 (hydroxymethyl)-2-methoxy-tetrahydropyran-3,4,5-triol
HO OH
OH
Dapoxetine Hydrochloride
O N
O OH
O OH
MM3523.01-
(1R)-3-(1-Naphthyloxy)-1-phenylpropan-1-ol 156453-53-1 25mg
0025
Dapsone
H2 N NH2
Darifenacin Hydrobromide
O
N
MM3525.00 Darifenacin Hydrobromide 133099-07-7 250mg HBr
N H2
Darunavir Ethanolate
H O O O O
MM3624.00-
Darunavir Ethanolate 635728-49-3 250mg O
H
O N
H
OH
N
S
NH2
0250 OH
MM3624.01- O
tert-Butyl N-((1S)-1-Benzyl-3-chloro-2-oxopropyl)carbamate 102123-74-0 25mg
0025 O N Cl
H
O
O
H O O
MM3624.02- [(3R,3aS,6aR)-Hexahydrofuro[2,3-b]furan-3-yl] (2,5-
253265-97-3 25mg O N
O O
0025 Dioxopyrrolidin-1-yl) Carbonate H O
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-162
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
MM3624.03- N-[(2R,3S)-3-Amino-2-hydroxy-4-phenylbutyl]-N-(2- O O
S HCl
244634-31-9 25mg H 2N N
OH + O
0025 methylpropyl)-4-nitrobenzenesulfonamide Hydrochloride N
O
O O O
MM3624.04- tert-Butyl N-[(1S,2R)-1-Benzyl-2-hydroxy-3-[(2-methylpropyl) S
191226-98-9 25mg O N N
H
OH +O
0025 [(4-nitrophenyl)sulfonyl]amino]propyl]carbamate N
O
O
MM3624.05- tert-Butyl N-[(1S,2R)-1-Benzyl-2-hydroxy-3-[(2-methylpropyl)
160232-08-6 25mg O N NH
H
0025 amino]propyl]carbamate OH
O O
MM3624.06- 4-Amino-N-((2R,3S)-3-amino-2-hydroxy-4-phenylbutyl)-N-(2- S
169280-56-2 25mg H 2N N
0025 methylpropyl)benzenesulfonamide OH
N H2
4-Nitrophenyl (2S)-2-(tert-Butoxycarbonylamino)-3- O
MM3624.08- O
phenylpropanoate (N-BOC-L-Phenylalanine 4-Nitrophenyl 7535-56-0 25mg O N
H
O +O
0025 N
Ester) O
NH2
OH
MM1560.00 Phenylalanine (L-Phenylalanine) 63-91-2 250mg
O
MM3624.15- HCl
(2S,3S)-3-Amino-1-chloro-4-phenylbutan-2-ol Hydrochloride 166987-16-2 25mg
0025 H 2N Cl
OH
Dasatinib Monohydrate
N
MM3451.00- N
N
N
H
N
S
H
N
Cl H2O
O
0250
N
O
MM3451.01- + N
N N
N Cl
HO H
Dasatinib N-Oxide 910297-52-8 25mg N N
H S
0025 O
N
N
MM3451.02- N-(2-Chloro-6-methylphenyl)-2-[(6-chloro-2-methylpyrimidin- Cl
N Cl
H
302964-08-5 25mg N N
H S
0025 4-yl)amino]thiazole-5-carboxamide O
N N
MM3451.03- N N
Cl
MM3451.04- H 2N
2-Chloro-6-methylaniline 87-63-8 100mg
0100
MM3451.05- N N
4,6-Dichloro-2-methylpyrimidine 1780-26-3 25mg
0025
Cl Cl
N Cl
H
MM3451.06- H 2N N
S
2-Amino-N-(2-chloro-6-methylphenyl)thiazole-5-carboxamide 302964-24-5 25mg
0025 O
Cl
H
MM3451.07- O N
(2E)-N-(2-Chloro-6-methylphenyl)-3-ethoxyprop-2-enamide 863127-76-8 25mg O
0025
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-163
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
Cl Cl
MM3451.11-
3,4-Dichloro-5-hydroxy-2(5H)-furanone 766-40-5 25mg
0025 O O OH
OH
MM0182.05- N
1-(2-Hydroxyethyl)piperazine 103-76-4 100mg HN
0100
Daunorubicin Hydrochloride
O OH O
OH
NH2
OH
O OH O
OH
OH
NH2
OH
Deanol Acetamidobenzoate
O
OH
N
N
OH
OH
N
MM1681.02 Deanol 108-01-0 100mg
+ OH
N
MM1681.01 Deanol N-Oxide 10489-99-3 100mg
O
Debrisoquin Sulfate
NH
O O
Decamethonium Iodide
Decamethonium Iodide
+
+ N I
N
MM3044.00 1420-40-2 250mg 2
Decitabine
N H2
N N
N O
MM3526.00 Decitabine 2353-33-5 250mg
O
HO OH
O
MM0250.05- Methyl 4-Chlorobenzoate O
1126-46-1 25mg
0025 Related compound D (USP)
Cl
Decoquinate
O N
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-164
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
Deferasirox
O
OH
N
MM3527.00 Deferasirox 201530-41-8 250mg N
N
OH
HO
OH H O
H
N
MM3527.01 Disalicylamide 1972-71-0 100mg
O O
OH H O
MM3527.01- H
N
Disalicylamide 1972-71-0 25mg
0025 O O
MM3527.02- OH
4-Hydrazinobenzoic Acid 619-67-0 25mg H 2N
0025 N
H
MM3527.03- N OH
2-(2-Hydroxyphenyl)-4H-1,3-benzoxazin-4-one 1218-69-5 25mg
0025 O
MM0045.00- OH
Salicylic Acid 69-72-7 250mg
0250
OH
OH
Deferiprone
O
Deflazacort
O
O
MM1224.00- N
Deflazacort 14484-47-0 250mg HO
O
0250 H
H
H H
O
O
N
HO
H O
MM1224.01 21-Desacetoxydeflazacort 13649-88-2 100mg H
H H
O
O
N
HO
MM1224.01- H O
21-Desacetoxydeflazacort 13649-88-2 25mg H
0025 H H
O
HO
21-Desacetyldeflazacort O
N
HO
O
MM1224.02 Related compound C (USP): 11Beta,21-Dihydroxy-2'-methyl- 13649-57-5 100mg H
H
H H
5'BetaH-pregna-1,4-dieno[17,16-d]oxazole-3,20-dione O
HO
21-Desacetyldeflazacort O
N
MM1224.02- HO
O
Related compound C (USP): 11Beta,21-Dihydroxy-2'-methyl- 13649-57-5 25mg H
0025 H
H H
5'BetaH-pregna-1,4-dieno[17,16-d]oxazole-3,20-dione O
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-165
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
Delorazepam
H O
N
Cl N
MM1371.00 Delorazepam 2894-67-9 CS 100mg
Cl
OH
MM1200.03 Impurity C (EP): 3,5-Dibromo-2-hydroxybenzaldehyde 90-59-5 100mg
Br Br
MM1200.03- OH
Impurity C (EP): 3,5-Dibromo-2-hydroxybenzaldehyde 90-59-5 25mg
0025
Br Br
Br
OH
MM1200.05 Impurity E (EP): 2,4,6-Tribromophenol 118-79-6 100mg
Br Br
Br
MM1200.05- OH
Impurity E (EP): 2,4,6-Tribromophenol 118-79-6 25mg
0025
Br Br
Demecarium Bromide
+
N
N O
N
O
N
+
Br
2
Demeclocycline Hydrochloride
OH O OH O O
OH
NH2
Dequalinium Chloride
H 2N
Cl
Dequalinium Chloride
+
N +
N
MM1705.00 522-51-0 100mg Cl
N H2
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-166
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
Deracoxib
O
F O O
S
NH2
Desipramine Hydrochloride
N N HCl
MM0589.00 Desipramine Hydrochloride 58-28-6 250mg H
MM0077.00- N N HCl
Impurity A (EP) as Hydrochloride: Imipramine Hydrochloride 113-52-0 250mg
0250
NH
MM0076.06 Iminodibenzyl 494-19-9 100mg
MM0076.06- NH
Iminodibenzyl 494-19-9 25mg
0025
Desloratadine
Cl
NH
MM0257.01-
Desloratadine 100643-71-8 250mg
0250 N
Cl
F NH
MM3528.01- Impurity A (EP): (11RS)-8-Chloro-11-fluoro-11-(piperidin-4-
298220-99-2 25mg
0025 yl)-6,11-dihydro-5H-benzo[5,6]cyclohepta[1,2-b]pyridine
N
O
Cl
NH
Deschlorodesloratadine Hydrochloride (6,11-Dihydro-11-
HCl
MM0257.19 (piperidin-4-ylidene)-5H-benzo[5,6]cyclohepta[1,2-b]pyridine n/a 100mg N
Hydrochloride)
NH
Deschlorodesloratadine Hydrochloride (6,11-Dihydro-11-
MM0257.19- HCl
(piperidin-4-ylidene)-5H-benzo[5,6]cyclohepta[1,2-b]pyridine n/a 25mg N
0025
Hydrochloride)
Cl
N
8-Chloro-11-(1-methylpiperidin-4-ylidene)-6,11-dihydro-5H-
MM0257.05 38092-89-6 100mg
benzo[5,6]cyclohepta[1,2-b]pyridine N
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-167
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
Cl
MM0257.05- 8-Chloro-11-(1-methylpiperidin-4-ylidene)-6,11-dihydro-5H-
38092-89-6 25mg
0025 benzo[5,6]cyclohepta[1,2-b]pyridine N
O
Cl
N-Formyldesloratadine
N
MM0257.15- Related compound F (USP): 8-Chloro-6,11-dihydro-11-(N-
117810-61-4 25mg
0025 formyl-4-piperidinylidene) -5H-benzo[5,6]cyclohepta[1,2-b] N
pyridine
Cl
N
N O
MM0257.25- N-Nitrosodesloratadine (8-Chloro-6,11-dihydro-11-(1-nitroso-
1246819-22-6 25mg
0025 4-piperidinylidene)-5H-benzo[5,6]cyclohepta[1,2-b]pyridin) N
Desogestrel
OH
MM1024.00-
Desogestrel 54024-22-5 250mg H H
0250 H H
OH
Desoxycortone Acetate
O O
H H
O
H2O
O
HO
OH
HO
N,O-Didesmethylvenlafaxine Hydrochloride OH
MM0393.05- H
HCl
Related compound B (USP): 4-[1-(1-Hydroxycyclohexyl)-2- 300827-92-3 25mg N
0025
(methylamino)ethyl]phenol HO
MM0393.15- N
(4-Methoxyphenyl)acetonitrile 104-47-2 100mg
0100 O
Detomidine Hydrochloride
H
N
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-168
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
Dexamethasone
O
OH
HO OH
F H
O
F H
(Betamethasone) O
O
OH
Impurity C (EP): 9-Fluoro-11 ,17,21-trihydroxy- HO
H
OH
O
Impurity D (EP): 9 ,11 -Epoxy-17,21-dihydroxy-16 - OH
OH
O
MM0213.04 methylpregna-1,4-diene-3,20-dione (Dexamethasone 9,11- 24916-90-3 100mg
H H
Epoxide) O
O
Impurity D (EP): 9 ,11 -Epoxy-17,21-dihydroxy-16 - OH
MM0213.04- OH
O
methylpregna-1,4-diene-3,20-dione (Dexamethasone 9,11- 24916-90-3 25mg
0025 H H
Epoxide) O
O
OH
MM0213.05- Impurity E (EP): 17,21-Dihydroxy-16 -methylpregna-1,4,9 OH
H
13209-41-1 25mg
0025 (11)-triene-3,20-dione H
O
O
OH
Impurity F (EP): 9-Fluoro-11 ,21-dihydroxy-16 - HO
H
MM0213.06 382-67-2 100mg
methylpregna-1,4-diene-3,20-dione F H
O
O
O
Impurity G (EP): 9-Fluoro-11 ,17-dihydroxy-16 - HO OH
O
(Dexamethasone Acetate) O
F H
O
O
O
Impurity H (EP): 17-Hydroxy-16 -methyl-3,20-dioxopregna- OH
H
MM0445.08 10106-41-9 100mg
1,4,9(11)-trien-21-yl Acetate H
O
O
O
O
MM0445.08- Impurity H (EP): 17-Hydroxy-16 -methyl-3,20-dioxopregna- OH
H
10106-41-9 25mg
0025 1,4,9(11)-trien-21-yl Acetate H
O
O OH
MM0213.13- Impurity J (EP): 17,21-Dihydroxy-16 -methylpregna-1,4- OH
H
2036-77-3 25mg
0025 diene-3,11,20-trione H H
O
O
HO
Dexamethasone-17-ketone (9a-Fluoro-11ß-hydroxy-16a- H
MM0213.10 1880-61-1 100mg F
methylandrosta-1,4-diene-3,17-dione) H
O
O
HO
MM0213.10- Dexamethasone-17-ketone (9a-Fluoro-11ß-hydroxy-16a- H
1880-61-1 25mg F
0025 methylandrosta-1,4-diene-3,17-dione) H
O
O
HO
MM0213.11- HO
(Z)-9-Fluoro-11ß,20-dihydroxy-16a-methylpregna-1,4,17(20)-
1174035-75-6 25mg H
0025 triene-3,21-dione F H
O
O
OH
HO H
MM0213.15- 9-Fluoro-11 -hydroxy-16 -methyl-3-oxoandrosta-1,4-diene- H
75262-69-0 25mg
0025 17 -carboxylic Acid F H
O
O
O
17-Hydroxy-16 -methyl-3,20-dioxo-9 ,11 -epoxypregna-1,4- O
MM0445.06- OH
O
dien-21-yl Acetate (9,11 -Epoxy-17-hydroxy-16 -methyl- 2884-51-7 25mg
0025 H H
O O
O
HO OH
MM0445.01- 9-Fluoro-11 ,17-dihydroxy-16 -methyl-3,20-dioxopregn-4-en- H
1524-94-3 25mg
0025 21-yl Acetate F H
O
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-169
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
O OH
MM0213.17- OH
H
11-Dehydrodexamethasone 2964-81-0 25mg
0025 F H
O
HO
HO OH
MM0213.18- OH
H
20-Dihydrodexamethasone 55879-48-6 25mg
0025 F H
O
O
HO O
MM0213.20- H
Dexamethasone Oxetanone 4089-36-5 25mg
0025 F H
O
OH
HO
MM0200.11- 9-Fluoro-11 ,21-dihydroxy-16-methylpregna-1,4,16-triene- H
59860-99-0 25mg
0025 3,20-dione F H
O
O
O
HO OH
MM0213.22- H
Dexamethasone Acid Ethyl Ester n/a 25mg
0025 F H
O
O
O
O
MM0213.23- HO OH
17 -Carboxy-17 -formyloxydexamethasone 473273-04-0 25mg H
0025 F H
O
O
O
H
MM0213.24- HO OH
H H2 O
21-Dehydrodexamethasone Dihydrate n/a 25mg 2
F H
0025 O
Dexamethasone Acetate
O
O
O
HO OH
MM0445.00 Dexamethasone Acetate 1177-87-3 250mg H
F H
O
F H
(Dexamethasone) O
O
O
Impurity D (EP): 9-Fluoro-11 ,17-dihydroxy-16 - HO OH
O
(Betamethasone Acetate) O
F H
O O
O
HO OH
MM0445.01- Impurity E (EP): 9-Fluoro-11 ,17-dihydroxy-16 -methyl-3,20- H
1524-94-3 25mg
0025 dioxopregn-4-en-21-yl Acetate F H
O
O
O
O
MM0445.06- Impurity F (EP): 9,11 -Epoxy-17-hydroxy-16 -methyl-3,20- OH
O
2884-51-7 25mg
0025 dioxo-9 -pregna-1,4-dien-21-yl Acetate H H
O
O
O
O
MM0445.07- Impurity G (EP): 9-Fluoro-11 -hydroxy-16 -methyl-3,20- HO
H
1597-78-0 25mg
0025 dioxopregna-1,4-dien-21-yl Acetate F H
O
O
O
O
Impurity H (EP): 17-Hydroxy-16 -methyl-3,20-dioxopregna- OH
H
MM0445.08 10106-41-9 100mg
1,4,9(11)-trien-21-yl Acetate H
O
O
O
O
MM0445.08- Impurity H (EP): 17-Hydroxy-16 -methyl-3,20-dioxopregna- OH
H
10106-41-9 25mg
0025 1,4,9(11)-trien-21-yl Acetate H
O
O
O O
Impurity I (EP): 9-Fluoro-17-hydroxy-16 -methyl-3,20- O
MM0445.09- O OH
H
dioxopregna-1,4-diene-11 ,21-diyl Diacetate 3949-26-6 25mg
0025 F H
(Dexamethasone 11,21-Diacetate) O
O
HO O
MM0213.20- H
Dexamethasone Oxetanone 4089-36-5 25mg
0025 F H
O
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-170
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
O
O
H
MM0213.24- HO OH
H H2 O
21-Dehydrodexamethasone Dihydrate n/a 25mg 2
F H
0025 O
O OH
MM0213.13- OH
H
17,21-Dihydroxy-16 -methylpregna-1,4-diene-3,11,20-trione 2036-77-3 25mg
0025 H H
O
O
OH
HO H
MM0213.15- 9-Fluoro-11 -hydroxy-16 -methyl-3-oxoandrosta-1,4-diene- H
75262-69-0 25mg
0025 17 -carboxylic Acid F H
O
Dexamethasone Isonicotinate
O
O
O
MM3804.00- HO OH
N
H
Dexamethasone Isonicotinate 2265-64-7 250mg
0250 F H
O
O
OH
HO OH
Impurity A (EP): A. 9-Fluoro-11 ,17,21-trihydroxy-16 - H
MM0213.00 50-02-2 250mg
methylpregna-1,4-diene-3,20-dione (Dexamethasone) F H
O
O
O
Impurity B (EP): 9-Fluoro-11 ,17-dihydroxy-16 -methyl-3,20- O
HO OH
MM0445.00 H
dioxopregna-1,4-dien-21-yl Acetate (Dexamethasone 1177-87-3 250mg
F H
Acetate) O
O
O
O
MM0445.06- 9,11 -Epoxy-17-hydroxy-16 -methyl-3,20-dioxo-9 -pregna- OH
O
2884-51-7 25mg
0025 1,4-dien-21-yl Acetate H H
O
F H
O
O
OH
Impurity A (EP): 9-Fluoro-11 ,17,21-trihydroxy-16 - HO
H
OH
+
O O O Na
Impurity B (EP) as Disodium Salt: 9-Fluoro-11 ,17-dihydroxy- O
P
O Na
+
HO OH
H
MM0303.00 16 -methyl-3,20-dioxopregna-1,4-dien-21-yl Disodium 151-73-5 250mg
F H
O
Phosphate (Betamethasone Sodium Phosphate)
O
OH
HO OH
MM0210.07- Impurity G (EP): 9-Fluoro-11 ,17 -dihydroxy-16 -methyl-3- H
37927-01-8 25mg
0025 oxoandrosta-1,4-diene-17 -carboxylic Acid F H
O
O N
MM0210.12- 9-Fluoro-11 ,17-dihydroxy-16 -methyl-3,20-dioxopregna-1,4- HO OH
O P
N
3864-50-4 25mg O
H
O
0025 dien-21-yl Dimorpholinophosphinate F H
O
O
O
17-Hydroxy-16 -methyl-3,20-dioxo-9 ,11 -epoxypregna-1,4- O
MM0445.06- OH
O
dien-21-yl Acetate (9,11 -Epoxy-17-hydroxy-16 -methyl- 2884-51-7 25mg
0025 H H
O
HO O
MM0213.20- H
Dexamethasone Oxetanone 4089-36-5 25mg
0025 F H
O
O
O
H
MM0213.24- HO OH
H H2 O
21-Dehydrodexamethasone Dihydrate n/a 25mg 2
0025 F H
O
O OH
MM0213.13- OH
H
17,21-Dihydroxy-16 -methylpregna-1,4-diene-3,11,20-trione 2036-77-3 25mg
0025 H H
O
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-171
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
O
OH
HO H
MM0213.15- 9-Fluoro-11 -hydroxy-16 -methyl-3-oxoandrosta-1,4-diene- H
75262-69-0 25mg
0025 17 -carboxylic Acid F H
O
MM0528.05- O
Impurity D (EP): Benzaldehyde 100-52-7 500mg
0500
NH2
MM0741.00- O O
S
Amfetamine Sulfate 60-13-9 CS 250mg HO OH
0250 2
O
+
MM1359.03- N
[(1E)-2-Nitro-1-propen-1-yl]benzene 18315-84-9 25mg O
0025
Dexchlorpheniramine Maleate
Cl
O
OH
MM1114.00 Dexchlorpheniramine Maleate 2438-32-6 100mg N
OH
N
O
OH
phenyl-3-(pyridin-2-yl)propan-1-amine Maleate 132-20-7 250mg OH
Cl
HCl
MM1114.03 Dexchlorpheniramine N-Oxide Dihydrochloride n/a 100mg N +
2
N
O
Dexibuprofen
OH
MM3534.00 Dexibuprofen 51146-56-6 250mg
O
O
MM3534.01 Dexibuprofen Methyl Ester 81576-55-8 100mg O
O
MM3534.02 Dexibuprofen Ethyl Ester 272458-63-6 100mg O
O
MM3534.03 Dexibuprofen Isopropyl Ester 1114975-39-1 100mg O
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-172
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
O OH
Dexibuprofen 1,3-Butylene Glycol Esters (Mixture of Regio-
MM3534.04 n/a 100mg
and Stereoisomers) O OH
OH
O
MM3534.05 Dexibuprofen 2,3-Butylene Glycol Ester n/a 100mg O
OH
O
O
Dexibuprofen 1,2-Propylene Glycol Esters (Mixture of Regio-
MM3534.06 n/a 100mg
and Stereoisomers) O
OH
O
OH
O OH
O
Dexibuprofen 1,2,3-Propanetriol Esters (Mixture of Regio-
MM3534.07 n/a 100mg
and Stereoisomers) O
OH
O
OH
Dexketoprofen Trometamol
O
OH
O
OH
MM3535.08 Dexketoprofen 22161-81-5 250mg O
O
O
MM3535.01 Dexketoprofen Methyl Ester 81601-91-4 100mg O
O
O
MM3535.02 Dexketoprofen Ethyl Ester 136656-97-8 100mg O
O
O
MM3535.03 Dexketoprofen Isopropyl Ester 851775-73-0 100mg O
O
O
O OH
MM3535.04- Dexketoprofen 1,3-Butylene Glycol Esters (Mixture of Regio-
n/a 25mg O
0025 and Stereoisomers) O OH
O OH
MM3535.05- O
Dexketoprofen 2,3-Butylene Glycol Ester n/a 25mg O
0025
O OH
O
O
MM3535.06- Dexketoprofen 1,2-Propylene Glycol Esters (Mixture of
n/a 25mg O
0025 Regio- and Stereoisomers) O
OH
O
O OH
O OH
O
MM3535.07-
Dexketoprofen 1,2,3-Propanetriol Ester (Mixture of Isomers) n/a 25mg O
0025 O
OH
O
OH
0025 Benzoylphenyl)propanoate
O
MM3535.10- [2-[(2S)-2-(3-Benzoylphenyl)propanoyl]oxy-1-methylpropyl] O O
O O
n/a 25mg O
0025 (2S)-2-(3-Benzoylphenyl)propanoate
MM3535.11- O O
2-[(2S)-2-(3-Benzoylphenyl)propanoyl]oxypropyl (2S)-2-(3- O
O
n/a 25mg O O
0025 Benzoylphenyl)propanoate
Dexmedetomidine Hydrochloride
N
MM3355.00 Dexmedetomidine Hydrochloride 145108-58-3 250mg HCl
N
H
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-173
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
Dexpanthenol
O
MM1352.00-
Dexpanthenol 81-13-0 250mg HO
N
H
OH
0250 OH
O
HO
MM1352.03- (3R)-3-Hydroxy-4,4-dimethyldihydrofuran-2(3H)-one
599-04-2 25mg O
0025 (Pantolactone)
O
HO
MM1352.04 D,L-Pantolactone 79-50-5 100mg O
O
HO
MM1352.04-
D,L-Pantolactone 79-50-5 25mg O
0025
O
Calcium (D,L)-Pantoate (Calcium (RS)-2,4-Dihydroxy-3,3- HO
O Ca
2+
dimethylbutyrate)
MM1352.05 n/a 50mg
OH
2
O O
HO 2+
Ca
N O
MM1499.00 Calcium Pantothenate 137-08-6 250mg OH
H
2
Dexpropranolol Hydrochloride
OH
H
O N
MM3350.01 Dexpropranolol 5051-22-9 100mg
Dextromethorphan Hydrobromide
N
HBr
MM0033.00- Dextromethorphan Hydrobromide H
Monohydrate
6700-34-1 250mg H2O
0250
O
H
N
H
N
OH
MM0033.09 143-98-6 100mg
Methylmorphinan-3-ol (L)-Tartrate HO
O OH
N
MM0033.09- Impurity B (EP) as (L)-Tartrate: ent-17- H HO
OH O
OH
143-98-6 25mg
0025 Methylmorphinan-3-ol (L)-Tartrate HO
O OH
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-174
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
methylmorphinan-10-one H
MM0033.02
Related compound C (USP): 3-Methoxy-17-methyl-9
57969-05-8 100mg
Alpha,13 Alpha,14 Alpha-morphinan-10-one O
MM0033.02- methylmorphinan-10-one H
Related compound C (USP): 3-Methoxy-17-methyl-9
57969-05-8 25mg
0025
Alpha,13 Alpha,14 Alpha-morphinan-10-one O
O
+
N
O
MM0098.01-
Dextropropoxyphene Hydrochloride 1639-60-7 CS 250mg O
HCl
0250
(Acetoxyphene Hydrochloride)
n/a 25mg
0025
Related compound B (USP): alpha-d-2-Acetoxy-4-
dimethylamino-1,2-diphenyl-3-methylbutane
N
0025 (Butyroxy-Hydrochloride)
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-175
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
O
chloride
Dextrothyroxine Sodium
I
I O
NH2
MM1813.01 Dextrothyroxine 51-49-0 100mg HO I
OH
I O
Diacerein
O O
OH
O O
OH
HO
OH
Impurity A (Pharmeuropa): (10S)-1,8-Dihydroxy-3- O
HO
MM1318.01 (hydroxymethyl)-10- -D-glucopyranosyl-10H-anthracen-9-one 1415-73-2 100mg H H
OH
(Aloin, Barbaloin)
OH O OH
OH
HO
OH
Impurity A (Pharmeuropa): (10S)-1,8-Dihydroxy-3- O
MM1318.01- HO
(hydroxymethyl)-10- -D-glucopyranosyl-10H-anthracen-9-one 1415-73-2 25mg H H
OH
0025 (Aloin, Barbaloin)
OH O OH
Diamfenetide
O O
O O O
Diaveridine
O N NH2
NH2
Diazepam
O
N
MM0023.00-
Diazepam 439-14-5 CS 250mg Cl N
0250
H O
N
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-176
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
O
Cl
N
O
Cl
N
MM0023.03- methyl-4-phenylquinolin-2(1H)-one Cl N H2
Related compound B (USP): 3-Amino-6-chloro-1-methyl-4-
5220-02-0 25mg
0025
phenylcarbostyril
O
Cl
NH
O
MM0023.05 2'-Benzoyl-2,4'-dichloroacetanilide 4016-85-7 100mg Cl
O
Cl
NH
MM0023.05- O
2'-Benzoyl-2,4'-dichloroacetanilide 4016-85-7 25mg Cl
0025
Diazoxide
O O
Cl S
MM3038.00 Diazoxide 364-98-7 100mg NH
Dibenamine Hydrochloride
O
N
MM3037.02-
N,N-Dibenzyl-2-methoxyethanamine 57619-22-4 25mg
0025
O
N Cl
MM3037.05- N-Benzyl-N-(2-chloroethoxy)-1-phenylmethanamine HCl
n/a 25mg
0025 Hydrochloride
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-177
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
Dibutyl Phthalate
O
O
MM3386.00 Dibutyl Phthalate 84-74-2 250mg O
Dibutyl Sebacate
O O
2,4-Dichlorobenzyl Alcohol
OH
MM0739.00 2,4-Dichlorobenzyl Alcohol 1777-82-8 250mg
Cl Cl
Cl
OH
MM0739.02 Impurity A (EP): (2,5-Dichlorophenyl)methanol 34145-05-6 100mg
Cl
Cl
MM0739.02- OH
Impurity A (EP): (2,5-Dichlorophenyl)methanol 34145-05-6 25mg
0025 Cl
OH
OH
MM0739.04-
Impurity C (EP): (3,4-Dichlorophenyl)methanol 1805-32-9 25mg Cl
0025
Cl
O OH
Cl
MM0014.05 Impurity E (EP): 2,4-Dichlorobenzoic Acid 50-84-0 100mg
Cl
Dichloroxylenol
OH
Dichlorphenamide
O O O O
S S
H2 N NH2
MM1795.00 Dichlorphenamide 120-97-8 100mg Cl
Cl
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-178
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
Diclofenac Sodium
+
O Na
O
NH
MM0006.00 Diclofenac Sodium 15307-79-6 500mg Cl Cl
OH
OH
OH
O
Impurity D (EP): 2-[2-[(2-Bromo-6-chloro- NH
MM0006.09 127792-23-8 100mg
phenyl)amino]phenyl]acetic Acid Br Cl
OH
O
MM0006.09- Impurity D (EP): 2-[2-[(2-Bromo-6-chloro- NH
127792-23-8 25mg
0025 phenyl)amino]phenyl]acetic Acid Br Cl
+
O Na
O
Impurity D (EP) as Sodium Salt: Sodium 2-[2-[(2- NH
MM0006.05 127792-45-4 100mg
Bromo-6-chlorophenyl)amino]phenyl]acetate Br Cl
+
O Na
O
MM0006.05- Impurity D (EP) as Sodium Salt: Sodium 2-[2-[(2- NH
127792-45-4 25mg
0025 Bromo-6-chlorophenyl)amino]phenyl]acetate Br Cl
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-179
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
O
MM0006.02 Impurity E (EP): 1,3-Dihydro-2H-indol-2-one 59-48-3 100mg
N
H
MM0006.02- O
Impurity E (EP): 1,3-Dihydro-2H-indol-2-one 59-48-3 25mg
0025 N
H
Cl
HN
Impurity F (EP): N-(4-Chlorophenyl)-2-(2,6-dichlorophenyl)
MM0006.36 560075-65-2 100mg O
acetamide
Cl Cl
Cl
HN
MM0006.36- Impurity F (EP): N-(4-Chlorophenyl)-2-(2,6-dichlorophenyl)
560075-65-2 25mg O
0025 acetamide
Cl Cl
O
MM0006.06- N
1-(2-Bromo-6-chlorophenyl)indolin-2-one 1219112-85-2 25mg Br Cl
0025
Methyl 2-[2-[(2,6-Dichlorophenyl)amino]- NH
O
Ethyl 2-[2-[(2,6-Dichlorophenyl)amino]- NH
O
Isopropyl 2-[2-[(2,6-Dichlorophenyl)amino]- O
NH
MM0181.06 phenyl]acetate 66370-79-4 100mg Cl Cl
(Isopropyl Ester of Diclofenac)
Isopropyl 2-[2-[(2,6-Dichlorophenyl)amino]- O
MM0181.06- NH
phenyl]acetate 66370-79-4 25mg Cl Cl
0025 (Isopropyl Ester of Diclofenac)
OH
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-180
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
OH
MM0006.12-
2-(2,6-Dichlorophenylamino)benzoic Acid 13625-57-5 25mg NH
0025 Cl Cl
Cl
H
N
MM0006.15 2,6-Dichlorodiphenylamine 15307-93-4 100mg
Cl
Cl
H
MM0006.15- N
2,6-Dichlorodiphenylamine 15307-93-4 25mg
0025
Cl
MM0006.16- NH
2-Bromo-6-chlorodiphenylamine 123790-84-1 25mg Br Cl
0025
O
N
MM0006.17 1-(2,6-Dichlorophenyl)indolin-2,3-dione 24542-74-3 100mg
Cl Cl
+
O K
O
NH
MM0006.18 Diclofenac Potassium 15307-81-0 100mg Cl Cl
Cl
2-Chloro-N-(2,6-dichlorophenyl)-N- N O
MM0006.19
phenylacetamide
15308-01-7 100mg Cl Cl
Cl
MM0006.19- 2-Chloro-N-(2,6-dichlorophenyl)-N- N O
phenylacetamide
15308-01-7 25mg Cl Cl
0025
OH
O
MM0006.20- 2-[2-[(2,6-Dichlorophenyl)amino]phenyl]- NH
N H2
Cl Cl
MM0006.21 2,6-Dichloroaniline 608-31-1 100mg
N H2
MM0006.21- Cl Cl
2,6-Dichloroaniline 608-31-1 25mg
0025
NH2
Br Cl
MM0006.22 2-Bromo-6-chloroaniline 59772-49-5 100mg
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-181
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
NH2
MM0006.22- Br Cl
2-Bromo-6-chloroaniline 59772-49-5 25mg
0025
OH
O
NH
MM0006.23- Cl Cl
4'-Hydroxydiclofenac 64118-84-9 25mg
0025
OH
OH
O
NH H
MM0006.25 Diethylammonium Diclofenac 78213-16-8 250mg Cl Cl
N
N
MM0006.27 N-Acetyl-N-phenyl-2,6-dichloroaniline 84803-53-2 100mg Cl Cl
MM0006.27- N
N-Acetyl-N-phenyl-2,6-dichloroaniline 84803-53-2 25mg Cl Cl
0025
O
MM0006.28 Diethyl Phthalate 84-66-2 100mg O
H
N
MM0006.31 2'-Chloroacetanilide 533-17-5 100mg
O
Cl
H
N
MM0006.31-
2'-Chloroacetanilide 533-17-5 25mg
0025 O
Cl
Br
MM0006.32 Bromobenzene 108-86-1 100mg
O O OH
O OH O
NH NH
Cl Cl Cl Cl
MM0006.37 Diclofenac Butylene Glycol Ester (Mixture of Isomers) n/a 50mg
OH
O
O
NH
MM0006.38 Diclofenac 2,3-Butylene Glycol Ester 95093-57-5 100mg
Cl Cl
OH
O O
OH
O O
NH NH
MM0006.39 Diclofenac 1,2-Propylene Glycol Ester (Mixture of Isomers) n/a 100mg Cl Cl Cl Cl
Cl
MM0217.14- OH
2-Chlorobenzoic Acid 118-91-2 25mg
0025
Cl
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-182
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
OH
MM3572.04- Cl Cl
2,6-Dichlorophenol 87-65-0 100mg
0100
Dicloxacillin Sodium
O
Impurity C (EP): (2S,5R,6R)-6-Amino-3,3- OH
O
dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]- N
MM0026.04 551-16-6 100mg
heptane-2-carboxylic Acid
H 2N S
(6-Aminopenicillanic Acid) H
O
Impurity C (EP): (2S,5R,6R)-6-Amino-3,3- OH
O
MM0026.04- dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]- N
551-16-6 25mg
0025 heptane-2-carboxylic Acid
H 2N S
(6-Aminopenicillanic Acid) H
Dicumarol
O OO O
Didanosine
O
N
HN
MM1047.00 Didanosine 69655-05-6 250mg HO
N N
O
N H2
N
Impurity G (EP): 9-(2,3-Dideoxy- -D-glycero- N
MM1047.02 pentofuranosyl)-9H-purin-6-amine (2 ,3 -Dideoxyadenosine) 4097-22-7 100mg HO
N N
Related compound B (USP): 2',3'-dideoxyadenosine O
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-183
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
N H2
N
Impurity G (EP): 9-(2,3-Dideoxy- -D-glycero- N
MM1047.02-
pentofuranosyl)-9H-purin-6-amine (2 ,3 -Dideoxyadenosine) 4097-22-7 25mg HO
N N
0025 Related compound B (USP): 2',3'-dideoxyadenosine O
Dienogest
N
OH
H
O
H
MM1007.03 Impurity B (EP): Estra-4,9-diene-3,17-dione 5173-46-6 100mg
H
O
MM1007.03- H
Impurity B (EP): Estra-4,9-diene-3,17-dione 5173-46-6 25mg
0025 H
O
O
Impurity L (EP): Spiro[1,3-dioxolan-2,3 -estra-5 (10 ),9 (11 )-
MM1274.02- H
dien]-17 -one (Estra-5(10),9(11)-diene-3,17-dione 3-Ethylene 5571-36-8 25mg O H
0025
Ketal) O
Diethanolamine Fusidate
O
H OH
MM3832.00- HO HO OH
O
Diethanolamine Fusidate 16391-75-6 100mg H O
N
H
0100 HO
H
Diethazine Hydrochloride
N
N
MM1593.00 Diethazine Hydrochloride 341-70-8 50mg S
HCl
+
N HCl
MM1593.08- N
O
Diethazine N-Oxide Hydrochloride n/a 25mg S
0025
N
MM1593.03- N
Diethazine Sulfoxide 10078-16-7 25mg S
0025 O
N
MM1593.04- N
Diethazine Sulfone 13401-03-1 25mg O S
0025 O
+
N HCl
MM1593.09- Diethazine Sulfoxide N-Oxide Hydrochloride (Diethazine N,S- N
O
n/a 25mg S
O
0025 Dioxide Hydrochloride)
+
N HCl
MM1593.10- Diethazine Sulfone N-Oxide Hydrochloride (Diethazine N
O
n/a 25mg O S
0025 N,S,S-Trioxide Hydrochloride) O
Diethylammonium Salicylate
O
H
MM3461.00 Diethylammonium Salicylate 4419-92-5 250mg OH N
OH
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-184
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
Diethylcarbamazine Citrate
O
O OH
O
OH
O
Diethylstilbestrol
OH
Difenidol Hydrochloride
O
MM3053.01- +
N
Difenidol N-Oxide 40220-79-9 25mg OH
0025
Diflorasone Diacetate
O
O
O O
HO O
MM3529.00 Diflorasone Diacetate 33564-31-7 250mg H
F H
O
F
OH
O
HO OH
H
MM3529.01 Diflorasone 2557-49-5 100mg
F H
O
OH
O
HO OH
MM3529.01- H
Diflorasone 2557-49-5 25mg
0025 F H
O
N HCl
MM3418.01 Difloxacin Hydrochloride 91296-86-5 250mg N N
OH
F
O O
O
+
N
MM3418.04 Difloxacin N-Oxide Sodium Salt n/a 100mg N N
+
O Na
F
O O
O
MM3418.04- +
N
Difloxacin N-Oxide Sodium Salt n/a 25mg N N
0025 +
O Na
F
O O
Diflucortolone Valerate
O
O
O
HO
H
O
F
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-185
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
Diflunisal
F
O
F
O
F
O
MM3050.01-
Diflunisal Methyl Ester 55544-00-8 25mg O
0025 F
OH
F
O
MM3050.02-
Diflunisal Ethyl Ester 126093-86-5 25mg O
0025 F
OH
F
O
MM3050.03-
Diflunisal Isopropyl Ester 1381777-24-7 25mg O
0025 F
OH
Difluprednate
O
O
O O
HO O
MM3567.00 Difluprednate 23674-86-4 250mg H
F H
O
F
Digitoxin
O O
MM0336.01-
Digitoxigenin 143-62-4 25mg H
0025 H OH
HO
H
Digoxin
O O O O
O
HO
H
OH
HCl
MM0812.07 Dihydrocodeine Hydrochloride 36418-29-8 CS 100mg H
O O OH
O O OH
OH
H2O
MM0442.00 41444-62-6 CS 100mg O
Phosphate Hemihydrate O O OH
2
2
Hydrochloride Trihydrate HO O OH
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-186
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
O
+
N
O O OH
Dihydroergocristine Mesilate
H
N O O O
H
O
H
N
O
N
H
N
O
HO
S
OH
Dihydromorphine Hydrochloride
N
H
MM1369.01 Dihydromorphine 509-60-4 CS 100mg
HO O OH
Diisopropyl Adipate
O
HO
MM1008.02 Adipic Acid 124-04-9 250mg OH
O
Diloxanide Furoate
O
O O
MM3049.00 Diloxanide Furoate 3736-81-0 250mg Cl
N
O
Cl
Diltiazem Hydrochloride
O
S
MM0068.00-
Diltiazem Hydrochloride 33286-22-5 250mg N
O
O
HCl
0250 O
O
Impurity D (EP) as Hydrochloride: (2S,3S)-2-(4-
Methoxyphenyl)-5-[2-(methylamino)ethyl]-4- S
O
3-yl Acetate Hydrochloride (N-Desmethyl-
diltiazem Hydrochloride) HN
O
Impurity D (EP) as Hydrochloride: (2S,3S)-2-(4-
MM0068.03- Methoxyphenyl)-5-[2-(methylamino)ethyl]-4- S
O
0025 3-yl Acetate Hydrochloride (N-Desmethyl-
diltiazem Hydrochloride) HN
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-187
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
O
S
O
MM0068.07 Diltiazem Sulphoxide 370094-12-5 100mg N O
O
O
S
MM0068.07- O
Diltiazem Sulphoxide 370094-12-5 25mg N O
0025 O
NH2
(2S,3S)-3-(2-Aminophenyl)sulfanyl-2-hydroxy-3-(4- S
MM0068.13 42399-48-4 100mg
methoxyphenyl)propanoic Acid OH
HO
O
NH2
MM0068.13- (2S,3S)-3-(2-Aminophenyl)sulfanyl-2-hydroxy-3-(4- S
42399-48-4 25mg
0025 methoxyphenyl)propanoic Acid OH
HO
O
Dimenhydrinate
O
H
Dimenhydrinate
N
N
N Cl
MM0599.00 523-87-5 500mg O O N N
O
H
N N
MM0176.00 Impurity A (EP): Theophylline 58-55-9 500mg
O N N
8-[(2-(Diphenylmethoxy)ethyl)(methyl)- O
O
MM0599.04 amino]-1,3-dimethyl-3,7-dihydro-1H- 33120-34-2 100mg N
H
N
N
purine-2,6-dione O N N
MM0599.04- 8-[(2-(Diphenylmethoxy)ethyl)(methyl)- O
O
amino]-1,3-dimethyl-3,7-dihydro-1H- 33120-34-2 25mg N
H
N
N
0025 purine-2,6-dione O N N
N
MM0494.00- N
Impurity C (EP): Caffeine 58-08-2 250mg
0250
O N N
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-188
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
HCl
Impurity D (EP) as Dihydrochloride: N-[2-(Diphenylmethoxy) 2
MM0599.08- dihydro-1H-purine-2,6-dione N
N
(8-Chlorocaffeine) 4921-49-7 25mg Cl
N
0025 Related compound E (USP): 8-chloro-3,7-dihydro-1,3,7- O N
trimethyl-1H-purine-2,6-dione
Impurity F (EP) as Hydrochloride: 2-(Diphenyl-
methoxy)-N-methylethanamine Hydrochloride H HCl
MM0490.03 53499-40-4 100mg N
(Diphenhydramine Impurity A Hydrochloride; O
Nordiphenhydramine Hydrochloride)
Impurity F (EP) as Hydrochloride: 2-(Diphenyl-
MM0490.03- methoxy)-N-methylethanamine Hydrochloride H HCl
53499-40-4 25mg N
0025 (Diphenhydramine Impurity A Hydrochloride; O
Nordiphenhydramine Hydrochloride)
Impurity G (EP) as Hydrochloride: N,N-Dimethyl-
2-[(RS)-(4-methylphenyl)(phenyl)methoxy]- HCl
MM0490.04 4024-34-4 100mg N
ethanamine Hydrochloride (4-Methyldiphen- O
hydramine Hydrochloride)
Impurity G (EP) as Hydrochloride: N,N-Dimethyl-
MM0490.04- 2-[(RS)-(4-methylphenyl)(phenyl)methoxy]- HCl
4024-34-4 25mg N
hydramine Hydrochloride)
Impurity H (EP) as Hydrochloride: 2-[(RS)-(4-
Bromophenyl)(phenyl)methoxy]-N,N-dimethyl-
HCl
MM0640.00 ethanamine Hydrochloride (4-Bromodiphen- 1808-12-4 100mg O
N
chloride)
OH
OH
MM0490.02-
Impurity I (EP): Diphenylmethanol (Benzhydrol) 91-01-0 25mg
0025
O
MM0630.01-
Impurity J (EP): Diphenylmethanone (Benzophenone) 119-61-9 25mg
0025
MM0490.00-
Diphenhydramine Hydrochloride 147-24-0 250mg N
0250 O
HCl
O
H
N N
MM0155.02 8-Chlorotheophylline 85-18-7 100mg Cl
O N N
8-[N-(2-Diphenylmethoxyethyl)-N,N- N
N
N
+
inner salt
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-189
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
MM0599.03- 8-[N-(2-Diphenylmethoxyethyl)-N,N- N
N
N
+
Dimethadione
O O
Dimethisoquin Hydrochloride
N
O
Dimethyl Fumarate
O
O
MM3170.00 Dimethyl Fumarate 624-49-7 250mg O
O
O
Monomethyl Fumarate HO
MM0352.03 O
Related compound A (USP)
2756-87-8 100mg
O
O
MM0352.03- Monomethyl Fumarate HO
O
Related compound A (USP)
2756-87-8 25mg
0025 O
O O
MM3170.01- O
Dimethyl Maleate 624-48-6 100mg
0100 O
O
MM0460.10- HO
Fumaric Acid 110-17-8 250mg OH
0250 O
Dimethyl Terephthalate
O
O
MM2520.00 Dimethyl Terephthalate 120-61-6 250mg O
Dimetindene Maleate
O
MM0595.00- OH
Dimetindene Maleate 3614-69-5 250mg N
N
OH
0250 O
N
MM0595.01 Impurity A (EP): 2-Ethylpyridine 100-71-0 100mg
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-190
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
HCl
Impurity F (EP) as Hydrochloride: 2-(3-Butyl-1H-
MM0595.06 inden-2-yl)-N,N-dimethylethanamine Hydro- n/a 50mg N
chloride
0025 chloride
Impurity I (EP) as Maleate: N-Methyl-2-[3-[(1RS)- O
OH
MM0595.11 1-(pyridin-2-yl)ethyl]-1H-inden-2-yl]ethanamine 135784-57-5 50mg N
N
H
OH
Maleate O
+
N HCl
O 2
MM0595.13 Dimetindene N-Oxide Dihydrochloride n/a 100mg N
Dimetridazole
O
+ N
MM3059.00 Dimetridazole N
551-92-8 250mg O
N
Diosmin
OH
HO O
O
HO
O O
OH
O
OH OH O
OH
O
Impurity A (EP): 1-(3-Hydroxy-4-methoxyphenyl)ethan-1-one
MM0816.01 6100-74-9 100mg
(Acetoisovanillone) O
OH
O
MM0816.01- Impurity A (EP): 1-(3-Hydroxy-4-methoxyphenyl)ethan-1-one
6100-74-9 25mg
0025 (Acetoisovanillone) O
5-hydroxy-2-(3-hydroxy-4-methoxyphenyl)-
O O O
HO O
MM0816.02 520-26-3 100mg OH
HO OH
2,3-dihydro-4H-1-benzopyran-4-one
OH OH O
(Hesperidin)
Impurity B (EP): (2S)-7-[[6-O-(6-Deoxy- -L-
MM0816.02- mannopyranosyl)- -D-glucopyranosyl]oxy]- HO
O
OH
O
5-hydroxy-2-(3-hydroxy-4-methoxyphenyl)-
O O O
HO O
520-26-3 25mg OH
HO OH
0025
2,3-dihydro-4H-1-benzopyran-4-one
OH OH O
(Hesperidin)
OH
(Diosmetin) OH O
OH
0025 (Diosmetin) OH O
OH
(Hesperetin) OH O
OH
0025 (Hesperetin) OH O
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-191
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
Diperodon Hydrochloride
O
N O N
H
O O
MM3054.01 Diperodon 101-08-6 100mg HN
Diphemanil Metilsulfate
+
N
O O
MM1163.01-
4-Diphenylmethylene-1-methylpiperidine 6071-93-8 25mg
0025
Diphenhydramine Hydrochloride
MM0490.00-
Diphenhydramine Hydrochloride 147-24-0 250mg N
0250 O
HCl
(4-Methyldiphenhydramine Hydrochloride)
Impurity B (EP) as Hydrochloride: 2-[(RS)-
MM0490.04- (4-Methylphenyl)phenylmethoxy]-N,N- HCl
4024-34-4 25mg N
(4-Methyldiphenhydramine Hydrochloride)
Impurity C (EP) as Hydrochloride: 2-[(RS)-
(4-Bromophenyl)phenylmethoxy]-N,N- N
HCl
MM0640.00 1808-12-4 100mg
dimethylethanamine Hydrochloride Br
O
(Bromazine Hydrochloride)
OH
OH
MM0490.02-
Impurity D (EP): Diphenylmethanol (Benzhydrol) 91-01-0 25mg
0025
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-192
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
O
Impurity E (EP): Diphenylmethanone
MM0630.01 119-61-9 100mg
(Benzophenone)
O
MM0630.01- Impurity E (EP): Diphenylmethanone
119-61-9 25mg
0025 (Benzophenone)
MM0490.10- +O
Diphenhydramine N-Oxide Hydrochloride 13168-00-8 25mg N HCl
O
0025
3-(Benzhydryloxy)propane-1,2-diol
MM0490.09 Related compound B (USP): 3-(benzhydryloxy)propane-1,2- 19574-66-4 100mg
O OH
diol OH
3-(Benzhydryloxy)propane-1,2-diol
MM0490.09-
Related compound B (USP): 3-(benzhydryloxy)propane-1,2- 19574-66-4 25mg
0025 O OH
diol OH
Diphenoxylate Hydrochloride
HCl N
O O
Diphenylcyclopropenone
O
Diphenylpyraline Hydrochloride
O
OH
OH
MM0490.02-
Diphenylmethanol (Benzhydrol) 91-01-0 25mg
0025
O
MM0630.01-
Diphenylmethanone (Benzophenone) 119-61-9 25mg
0025
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-193
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
(4-(Diphenylmethoxy)piperidine Hydrochloride)
65214-86-0 25mg O
0025
Dipipanone Hydrochloride
piperidine Hydrochloride
110246-09-8 25mg N
0025
O
MM0028.03- Impurity A (EP): (2-Amino-5-chlorophenyl)phenyl- Cl
719-59-5 25mg
0025 methanone (Aminochlorobenzophenone)
H O
N
Diprafenon Hydrochloride
O OH
2'-Hydroxy-3-phenylpropiophenone (1-(2-Hydroxyphenyl)-3-
MM0405.02 3516-95-8 100mg
phenylpropan-1-one)
O OH
MM0405.02- 2'-Hydroxy-3-phenylpropiophenone (1-(2-Hydroxyphenyl)-3-
3516-95-8 25mg
0025 phenylpropan-1-one)
Diprenorphine
N
Diprophylline (Dyphylline)
OH
O
OH
N
MM1191.00 Diprophylline 479-18-5 250mg N
O N N
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-194
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
N
Impurity A (EP): N-Methyl-5-(methylamino)-1H- N
MM0176.01 6736-40-9 100mg H
imidazole-4-carboxamide (Theophyllidine) N
HN
H
N
MM0176.01- Impurity A (EP): N-Methyl-5-(methylamino)-1H- N
6736-40-9 25mg H
0025 imidazole-4-carboxamide (Theophyllidine) N
HN
H
O
H
N
Impurity B (EP): 1,3-Dimethyl-3,7-dihydro-1H- N
MM0176.00 58-55-9 500mg
purine-2,6-dione (Theophylline) N
O N
N OH
MM0603.00- Impurity C (EP): 7-(2-Hydroxyethyl)-1,3-dimethyl- N
519-37-9 250mg
0250 3,7-dihydro-1H-purine-2,6-dione (Etofylline) O N N
OH
O
Impurity D (EP): 7-[(2RS)-2-Hydroxypropyl]-1,3-
N
MM1284.00 dimethyl-3,7-dihydro-1H-purine-2,6-dione 603-00-9 250mg N
(Proxyphylline) O N N
Dipyridamole
OH
N
N N
N OH
MM0462.00 Dipyridamole 58-32-2 100mg HO
N N
N
OH
OH
Impurity A (EP): 2,2'-[[4,6,8-Tri(piperidin-1-yl)- N
pyrimido[5,4-d]pyrimidin-2-yl]nitrilo]diethanol N
N N
OH
N
Related compound A (USP): 2,2'-[4,6,8-Tri(piperidin-1-yl)
MM0462.01 16982-40-4 100mg N N
N
pyrimido[5,4-d]pyrimidin-2-yl]azanediyldiethanol
OH
Impurity A (EP): 2,2'-[[4,6,8-Tri(piperidin-1-yl)- N
MM0462.01- pyrimido[5,4-d]pyrimidin-2-yl]nitrilo]diethanol N
N N
OH
N
Related compound A (USP): 2,2'-[4,6,8-Tri(piperidin-1-yl)
16982-40-4 25mg N N
0025 N
pyrimido[5,4-d]pyrimidin-2-yl]azanediyldiethanol
OH
yl)pyrimido[5,4-d]pyrimidin-2-yl]nitrilo]diethanol N
N N
OH
MM0462.03 N
Related compound C (USP): 2,2'-[6-chloro-4,8-di(piperidin-
54093-92-4 100mg Cl N
N
1-yl)pyrimido[5,4-d]pyrimidin-2-yl]azanediyldiethanol
OH
MM0462.03- yl)pyrimido[5,4-d]pyrimidin-2-yl]nitrilo]diethanol N
N N
OH
N
Related compound C (USP): 2,2'-[6-chloro-4,8-di(piperidin-
54093-92-4 25mg Cl N
0025 N
1-yl)pyrimido[5,4-d]pyrimidin-2-yl]azanediyldiethanol
Disodium Edetate
O
+
Na HO O
MM0886.00- O
N
N
O H2 O
Disodium Edetate Dihydrate 6381-92-6 250mg O OH Na
+ 2
0250 O
O
OH
MM0886.01-
Impurity A (EP): Nitrilotriacetic Acid 139-13-9 100mg HO N
0100 O
O HO
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-195
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
Disopyramide
N
MM0108.00 Disopyramide 3737-09-5 500mg NH2
O
+
N
MM0108.09- N
HCl
Disopyramide N-Oxide Dihydrochloride n/a 25mg NH2 2
0025 O
Distigmine Bromide
O
+
+ O N N
N N O
Br
2
Disulfamide
O O O O
S S
MM3052.00 Disulfamide 671-88-5 50mg H2 N NH2
Cl
Disulfiram
N S
MM1946.00-
e Disulfiram 97-77-8 250mg N S
S N
0250 S
w
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-196
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
Dithranol (Anthralin)
OH O OH
O
MM0137.04- Impurity A (EP): Anthracen-9(10H)-one
90-44-8 25mg
0025 (Anthrone)
OH O OH
OH O OH
OH O OH
OH O OH
OH O OH
O OH
MM0137.05-
Impurity D (EP): 1-Hydroxyanthracen-9(10H)-one 1715-81-7 25mg
0025
Dobutamine Hydrochloride
OH
H
HO
N HCl
OH
(4-methoxyphenyl)butan-2-amine
Impurity C (EP) as Hydrochloride: (2RS)-N-[2-(3,4-
MM0675.03- Dimethoxyphenyl)ethyl]-4-(4-methoxyphenyl)butan-2-amine HCl
O
H
(4-methoxyphenyl)butan-2-amine
Docetaxel
HO O OH
H H
HO O
O
O
O O
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-197
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
HO O OH
Impurity C (EP): 5 ,20-Epoxy-1,7 ,10 -trihydroxy-9-oxotax-
H H
HO O
MM3396.07- 11-ene-2 ,4,13 -triyl 4-Acetate 2-Benzoate 13-[(2R,3S)-3- O OH
O
O
153381-68-1 25mg O
NH OO
0025 [[(1,1-Dimethylethoxy)carbonyl]amino]-2-hydroxy-3- O O
phenylpropanoate] (7-epi-Docetaxel)
HO O
OH
Impurity E (EP): 5 ,20-Epoxy-4-(acetyloxy)-1,7 ,10 ,13 - HO
H H
MM1489.07 tetrahydroxy-9-oxotax-11-en-2 -yl Benzoate (10-Desacetyl- 32981-86-5 100mg OH O
O
O
baccatin III; 10-O-Deacetylbaccatin III) O
O
HO O
OH
Impurity E (EP): 5 ,20-Epoxy-4-(acetyloxy)-1,7 ,10 ,13 - HO
MM1489.07- H H
tetrahydroxy-9-oxotax-11-en-2 -yl Benzoate (10-Desacetyl- 32981-86-5 25mg OH O
0025 O
O
baccatin III; 10-O-Deacetylbaccatin III) O
O
O
Impurity F (EP): 5 ,20-Epoxy-1,7 -dihydroxy-9-oxotax-11- O O
OH
OH
ene-2 ,4,10 ,13 -tetrayl 4,10-Diacetate 2-Benzoate 13- O
H H
MM1489.00 33069-62-4 100mg O NH O
OH O
O
[(2R,3S)-3-(Benzoylamino)-2-hydroxy-3-phenylpropanoate] O
O
O
(Paclitaxel)
Docetaxel Trihydrate
HO O OH
H H
HO O
Docetaxel Trihydrate
O
O O H2O
OH
MM3396.00 148408-66-6 250mg NH 3
OO
O
O O
HO O OH
Impurity C (EP): 5 ,20-Epoxy-1,7 ,10 -trihydroxy-9-oxotax-
H H
HO O
MM3396.07- 11-ene-2 ,4,13 -triyl 4-Acetate 2-Benzoate 13-[(2R,3S)-3- O OH
O
O
153381-68-1 25mg O
NH OO
0025 [[(1,1-Dimethylethoxy)carbonyl]amino]-2-hydroxy-3- O O
phenylpropanoate] (7-epi-Docetaxel)
O
(4S,5R)-3-(tert-Butoxycarbonyl)-2,2-dimethyl-4- OH
MM3396.03 143527-70-2 100mg O
phenyloxazolidine-5-carboxylic Acid N O
MM3396.03- (4S,5R)-3-(tert-Butoxycarbonyl)-2,2-dimethyl-4- OH
143527-70-2 25mg O
0025 phenyloxazolidine-5-carboxylic Acid N O
NH2 O
MM3396.04- Ethyl (2R,3S)-3-Amino-2-hydroxy-3-phenylpropanoate O HCl
257947-33-4 25mg OH
0025 Hydrochloride
O
O O
OH
OH
O
H H
MM1489.00 Paclitaxel 33069-62-4 100mg O NH O
OH O
O
O
O
O
HO O
OH
HO
H H
MM1489.07 10-O-Deacetylbaccatin III 32981-86-5 100mg OH O
O
O
O
O
HO O
OH
HO
MM1489.07- H H
10-O-Deacetylbaccatin III 32981-86-5 25mg OH O
0025 O
O
O
O
Dodecylguanidinium Acetate
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-198
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
Dolutegravir Sodium
+
Na
O O
MM3758.00- N
O F F
Dolutegravir Sodium 1051375-19-9 250mg H
N N
O
0250 H
O
Domiphen Bromide
O
Domiphen Bromide
+
N Br
Domperidone
O
MM0107.00- H
O
N
N
N
N
0250 Cl
O H
N
Impurity A (EP): 5-Chloro-1-(piperidin-4-yl)- N
MM0107.06 53786-28-0 100mg
1,3-dihydro-2H-benzimidazol-2-one HN
Cl
O H
N
MM0107.06- Impurity A (EP): 5-Chloro-1-(piperidin-4-yl)- N
53786-28-0 25mg
0025 1,3-dihydro-2H-benzimidazol-2-one HN
Cl
Cl
O N
formylpiperidine
Cl
O N
0025 formylpiperidine
Impurity F (EP): 1,3-Bis[3-[4-(5-
chloro-2-oxo-2,3-dihydro-1H- H
N
O O
H
N
benzimidazol-1-yl)piperidin-1-
N N
Cl
Cl N N N N
MM0107.03 n/a 50mg O
yl]propyl]-1,3-dihydro-2H-
benzimidazol-2-one
H
N
MM0107.07 1,3-Dihydro-2H-benzimidazol-2-one 615-16-7 100mg O
N
H
H
N
MM0107.07-
1,3-Dihydro-2H-benzimidazol-2-one 615-16-7 25mg O
0025 N
H
O H
N
MM0107.09- N
Donepezil Hydrochloride
N
MM0677.00-
Donepezil Hydrochloride 120011-70-3 250mg O
O
HCl
0250 O
methyl]indan-1-one Hydrochloride)
O
Impurity B (EP): 5,6-Dimethoxy-2,3-dihydro-1H-inden-1-one O
MM0677.19 2107-69-9 100mg
(5,6-Dimethoxyindan-1-one)
O
O
MM0677.19- Impurity B (EP): 5,6-Dimethoxy-2,3-dihydro-1H-inden-1-one O
2107-69-9 25mg
0025 (5,6-Dimethoxyindan-1-one)
O
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-199
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
N
Impurity D (EP): (2RS)-5,6-Dimethoxy-2-[(pyridin-4-yl) O
O
MM0677.08 methyl]-2,3-dihydro-1H-inden-1-one (5,6-Dimethoxy-2-[(4- 4803-57-0 100mg
O
pyridyl)methyl]indan-1-one)
N
Impurity D (EP): (2RS)-5,6-Dimethoxy-2-[(pyridin-4-yl) O
MM0677.08- O
methyl]-2,3-dihydro-1H-inden-1-one (5,6-Dimethoxy-2-[(4- 4803-57-0 25mg
0025 O
pyridyl)methyl]indan-1-one)
Impurity F (EP): (2E)-2-[(1-Benzylpiperidin-4-yl)methylidene]- O
O
MM0677.17- 5,6-dimethoxy-2,3-dihydro-1H-inden-1-one O
145546-80-1 25mg N
0025 Related compound A (USP): (E)-2-[(1-benzylpiperidin-4-yl)
methylene]-5,6-dimethoxyindan-1-one
2-[(1-Benzylpiperidin-4-yl)methylene]-2,3- O
N
MM0677.03 O
dihydro-5,6-dimethoxyinden-1-one
120014-07-5 100mg
O
MM0677.03- 2-[(1-Benzylpiperidin-4-yl)methylene]-2,3- O
N
120014-07-5 25mg O
0025 dihydro-5,6-dimethoxyinden-1-one
O
Br
MM0677.09- 1,1-Dibenzyl-4-[(5,6-dimethoxy-1oxo-2,3-dihydro- O
N
+
1H-inden-2-yl)methyl]piperidinium Bromide
844694-85-5 25mg O
0025
O
5,6-Dimethoxy-2-[(4-pyridyl)methylene]indan- O
O
MM0677.13
1-one
4803-74-1 100mg
O
MM0677.13- 5,6-Dimethoxy-2-[(4-pyridyl)methylene]indan- O
O
4803-74-1 25mg
0025 1-one O
O
+
N
MM0677.14-
Donepezil N-Oxide 120013-84-5 25mg O
O
0025 O
1-Benzyl-4-[(5,6-dimethoxy-2,3-dihydro-1H-inden- N
O
2-yl)methyl]piperidine
MM0677.15 844694-84-4 50mg
O
1-Benzyl-4-[(5,6-dimethoxy-1H-inden-2-yl)methyl]- N
MM0677.16 O
piperidine
120013-45-8 50mg
O
dimethoxy-1H-indene-1,3(2H)-dione)
1023500-88-0 25mg
0025 O
O
N
MM0677.22- 2-[(1-Benzylpiperidin-4-yl)hydroxymethyl]-5,6- O
197010-20-1 25mg O
N
MM0677.24- 2-[(1-Benzylpiperidin-4-yl)methyl]-3-hydroxy-5,6- O
O
2097683-67-3 25mg
0025 dimethoxyindan-1-one (3-Hydroxydonepezil) O
OH
Dopamine Hydrochloride
HO NH2
MM0384.00-
Dopamine Hydrochloride 62-31-7 250mg HO
HCl
0250
Impurity A (EP) as Hydrochloride: 5-(2-Amino-
ethyl)-2-methoxyphenol Hydrochloride HO NH2
HCl
MM0384.02
(4-O-Methyldopamine Hydrochloride)
645-33-0 100mg O
(4-O-Methyldopamine Hydrochloride)
645-33-0 25mg O
0025
Related compound A (USP)
Impurity C (EP): 2-(3,4-Dimethoxyphenyl)- O NH2
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-200
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
HO NH2
HBr
MM0384.01 (R,S)- -Methyldopamine Hydrobromide 3459-15-2 100mg HO
HO NH2
MM0384.01- HBr
(R,S)- -Methyldopamine Hydrobromide 3459-15-2 25mg HO
0025
Doramectin
O
H
HO O O O
O
O O
O
H
OH
O
H
HO O O O
O
MM3612.01- O O
H
O O O
0025 O
H
O
Dorzolamide Hydrochloride
O O
O S S
MM0403.00- O
0250 HN
Dosulepin Hydrochloride
N
MM0510.00-
Dosulepin Hydrochloride 897-15-4 250mg HCl
0250 S
N
Impurity A (EP): (E)-3-(5-Oxo-5 4-dibenzo[b,e]thiepin-11
MM0510.01 (6H)-ylidene)-N,N-dimethylpropan-1-amine (Dosulepin 42046-35-5 100mg
Sulfoxide) O
S
O
MM0510.02 Impurity B (EP): Dibenzo[b,e]thiepin-11(6H)-one 1531-77-7 100mg
S
O
MM0510.02-
Impurity B (EP): Dibenzo[b,e]thiepin-11(6H)-one 1531-77-7 25mg
0025
S
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-201
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
N
H
+
N
O
MM0510.13- Dosulepin Sulfoxide N-Oxide Hydrochloride (Dosulepin N,S-
n/a 25mg HCl
0025 Dioxide Hydrochloride) S
O
+
N
O
MM0510.14- Dosulepin Sulfone N-Oxide Hydrochloride (Dosulepin N,S,S-
n/a 25mg HCl
0025 Trioxide Hydrochloride) S
O
O
Doxapram Hydrochloride
N O
HCl
N
O
O
+
MM0525.03 Doxapram N-Oxide n/a 100mg N
O
Doxazosin Mesilate
O
N O
MM0386.00-
Doxazosin Mesilate 77883-43-3 250mg
O N
N
N O
O O O
0250 NH2 S
OH
N O
N
N O
O
NH2
O
Impurity A (EP): (2RS)-2,3-Dihydro-1,4-benzodioxine-
HO O
2-carboxylic Acid
MM0386.04 3663-80-7 100mg O
Related compound D (USP): 1,4-benzodioxane-2-carboxylic
acid
O
Impurity A (EP): (2RS)-2,3-Dihydro-1,4-benzodioxine-
HO O
MM0386.04- 2-carboxylic Acid
3663-80-7 25mg O
0025 Related compound D (USP): 1,4-benzodioxane-2-carboxylic
acid
MM0386.05- Dihydro-1,4-benzodioxin-2-ylcarbonyl]piperazine N O
HCl
Hydrochloride 70918-74-0 25mg HN O
2-ylcarbonyl)piperazine O N O
MM0386.06 O N O
Related compound F (USP): N,N'-bis(1,4-benzodioxane-2-
617677-53-9 100mg
O
carbonyl)piperazine
Impurity C (EP): 1,4-Bis(2,3-dihydro-1,4-benzodioxin- O
MM0386.06- 2-ylcarbonyl)piperazine O N O
O N O
Related compound F (USP): N,N'-bis(1,4-benzodioxane-2-
617677-53-9 25mg
0025 O
carbonyl)piperazine
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-202
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
dimethoxyquinazoline N
MM0085.06
Related compound E (USP): 2,4-dichloro-6,7-
27631-29-4 100mg O
Cl
dimethoxyquinazoline
Impurity E (EP): 2,4-Dichloro-6,7- O N Cl
MM0085.06- dimethoxyquinazoline N
Related compound E (USP): 2,4-dichloro-6,7-
27631-29-4 25mg O
0025 Cl
dimethoxyquinazoline
Impurity F (EP): 2-Chloro-6,7-dimethoxyquinazolin- O N Cl
4-amine N
O
Related compound C (USP): 2-chloro-4-amino-6,7-
MM0386.01 23680-84-4 100mg
NH2
dimethoxyquinazoline
Impurity F (EP): 2-Chloro-6,7-dimethoxyquinazolin- O N Cl
MM0386.01- 4-amine N
O
Related compound C (USP): 2-chloro-4-amino-6,7-
23680-84-4 25mg
0025 NH2
dimethoxyquinazoline
Impurity F (EP) as Mesilate: 2-Chloro-6,7-dimethoxy- O N Cl
quinazolin-4-amine Mesilate N
O
S
O
O
Related compound C (USP): 2-chloro-4-amino-6,7-
MM0386.12 n/a 100mg OH
NH2
dimethoxyquinazoline
Impurity F (EP) as Mesilate: 2-Chloro-6,7-dimethoxy- O N Cl
MM0386.12- quinazolin-4-amine Mesilate N
O
S
O
O
Related compound C (USP): 2-chloro-4-amino-6,7-
n/a 25mg OH
0025 NH2
dimethoxyquinazoline
NH
NH2
NH
60547-97-9 25mg
0025 yl)quinazolin-4-amine O
N
NH2
HCl H2O
Impurity G (EP) as Dihydrochloride Dihydrate: 6,7- 2 2 NH
MM0085.08- O N N
Dimethoxy-2-(piperazin-1-yl)quinazolin-4-amine n/a 25mg N
0025 O
Dihydrochloride Dihydrate NH2
NH2
O
N
NH2
NH2
O
N
102839-00-9 25mg
0025 dimethoxyquinazolin-4-amine) O
N
NH2
O O
MM0386.11-
Methyl (2RS)-1,4-Benzodioxane-2-carboxylate 3663-79-4 25mg O
0025
Doxepin Hydrochloride
N
MM0032.00-
Doxepin Hydrochloride 1229-29-4 250mg HCl
0250 O
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-203
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
propyl]-6,11-dihydrodibenzo[b,e]oxepin-11-ol
Impurity C (EP) as Maleate: (E)-3-(Dibenzo[b,e]oxepin-
MM0032.10- (6H)-ylidene)-N-methylpropan-1-amine Maleate N
H
O
OH
(Desmethyldoxepin Maleate) n/a 25mg O
OH
ylidene)-N-methylpropan-1-amine
Impurity C (EP) as Hydrochloride: (E)-3-(Dibenzo[b,e]oxepin-
N
11(6H)-ylidene)-N-methylpropan-1-amine Hydrochloride H
MM0032.13-
(Desmethyldoxepin Hydrochloride) 4504-96-5 25mg HCl
0025 O
Related compound C (USP): (E-3-(dibenzo[b,e]oxepin-11
(6H)-ylidene)-N-methylpropan-1-amine
NH
+
N
O
HCl
MM0032.12 Doxepin N-Oxide Hydrochloride n/a 100mg
O
+
N
O
MM0032.12- HCl
Doxepin N-Oxide Hydrochloride n/a 25mg
0025 O
Doxorubicin Hydrochloride
O OH O
OH
OH
NH2
OH
O OH
Impurity D (EP): (8S,10S)-6,8,10,11-Tetrahydroxy-8- O
OH
MM0283.01- OH
(hydroxyacetyl)-1-methoxy-7,8,9,10-tetrahydronaphthacene- 24385-10-2 25mg
0025 O O OH OH
5,12-dione (Doxorubicinone, Doxorubicin Aglycone)
Doxycycline Hyclate
OH O OH O O
OH HCl
2
N H2
OH N
2
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-204
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
MM0101.00-
Doxylamine Hydrogen Succinate 562-10-7 250mg N
O
N
OH
OH
0250 O
OH
MM0101.01 Dimethyl-2-[1(RS)-1-phenyl-1-(pyridin-4- n/a 50mg O
N OH
OH
MM0101.08-
N-Desmethyldoxylamine Hydrogen Succinate n/a 25mg N
O
H
N
OH
OH
0025 O
MM0101.09-
Phenyl(2-pyridyl)methanol 14159-57-0 25mg
0025 N
OH
MM0101.11-
(1RS)-1-Phenyl-1-(pyridin-2-yl)ethanol N-Oxide 100393-43-9 25mg OH
0025
+
N O
Drofenine Hydrochloride
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-205
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
Droperidol
F
N
O H
HN
MM0138.01- Impurity A (EP): 1-(1,2,3,6-Tetrahydropyridin- N
2147-83-3 25mg
0025 4-yl)-1,3-dihydro-2H-benzimidazol-2-one N
O H
+
Cl
(4-Fluorophenyl)-4-oxobutyl]-4-(2-oxo- O
N
+
N
H
n/a 25mg
0025 2,3-dihydro-1H-benzimidazol-1-yl)-1,2,3,6- HCl
O
N
N
H
Dropropizine
N OH
MM1017.00-
Dropropizine 17692-31-8 250mg N OH
0250
Drospirenone
O
O
MM1203.00- H
Drospirenone 67392-87-4 250mg
0250 H H
O
O
MM1203.05- Epidrospirenone) 90457-65-1 25mg
H
H
MM1203.12 3 ,5-Dihydroxy-15 ,16 -methylene-5 -androst-6-en-17-one 82543-15-5 100mg H H
HO
OH
MM1203.12- H
3 ,5-Dihydroxy-15 ,16 -methylene-5 -androst-6-en-17-one 82543-15-5 25mg H H
0025 HO
OH
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-206
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
Drostanolone Propionate
O
H H
O
H
Droxidopa
OH O
MM3786.00- OH
Droxidopa 23651-95-8 250mg NH2
0250 HO
OH
Duloxetine Hydrochloride
HCl
MM1122.00- S
Duloxetine Hydrochloride 136434-34-9 250mg
0250 O N
H
yloxy)-3-(thiophen-2-yl)propan-1-amine
S
Impurity B (EP): (1S)-3-(Methylamino)-1-(thiophen-2-yl)
MM1122.04 116539-55-0 100mg
propan-1-ol
HO N
H
S
MM1122.04- Impurity B (EP): (1S)-3-(Methylamino)-1-(thiophen-2-yl)
116539-55-0 25mg
0025 propan-1-ol
HO N
H
S
Impurity C (EP): 4-[(1RS)-3-(Methylamino)-1-(thiophen-2-yl)
MM1122.05 949095-98-1 100mg
propyl]naphthalen-1-ol N
H
HO
S
MM1122.05- Impurity C (EP): 4-[(1RS)-3-(Methylamino)-1-(thiophen-2-yl)
949095-98-1 25mg
0025 propyl]naphthalen-1-ol N
H
HO
OH
OH
MM0043.04-
Impurity D (EP): Naphthalen-1-ol (1-Naphthol) 90-15-3 25mg
0025
S
MM1122.07- 1-[(1RS)-3-(Methylamino)-1-(thiophen-2-yl)propyl]naphthalen-
1346599-09-4 25mg N
0025 2-ol H
OH
(S)-4-[Methyl[3-(naphthalen-1-yloxy)-3-(thiophen-2-yl)propyl]
S
MM1122.13- amino]-4-oxobutanoic Acid ((S)-Duloxetine Succinamide)
199191-66-7 25mg O N
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-207
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
S
MM1122.18-
(1S)-3-(Dimethylamino)-1-(thiophen-2-yl)propan-1-ol 132335-44-5 25mg
0025 HO N
O OH
MM1122.19- (3S)-N,N-Dimethyl-3-(naphthalen-1-yloxy)-3-(thiophen-2-yl) S
132335-47-8 25mg O N O OH
0025 propan-1-amine Oxalate (N-Methylduloxetine Oxalate)
MM1122.20- HCl
3-(Naphthalen-1-yloxy)propan-1-amine Hydrochloride 197504-23-7 25mg
0025 O NH2
S
MM1122.21- 3-(Dimethylamino)-1-(thiophen-2-yl)propan-1-one HCl
5424-47-5 25mg
0025 Hydrochloride O N
S
O
MM1122.22 3-Hydroxy-N-methyl-3-(thiophen-2-yl)propanamide 603996-87-8 100mg
HO N
H
S
MM1122.22- O
3-Hydroxy-N-methyl-3-(thiophen-2-yl)propanamide 603996-87-8 25mg
0025 HO N
H
Dutasteride
F F
O H
N F
O
OH
O
OH
O
O
F
F
F
H 2N
F
F
F
O
OH
H H
O
O
OH
MM1424.02-
4-Androsten-3-one-17 -carboxylic Acid 302-97-6 25mg H
0025 H H
O
O
O
H
MM0415.02 Methyl 3-Oxo-4-aza-5 -androst-1-ene-17 -carboxylate 103335-41-7 100mg
H H
O N
H H
O
O
MM0415.02- H
Methyl 3-Oxo-4-aza-5 -androst-1-ene-17 -carboxylate 103335-41-7 25mg
0025 H H
O N
H H
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-208
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
O
N
Cl
MM1424.11-
2,3-Dichloro-5,6-dicyano-1,4-benzoquinone (DDQ) 84-58-2 100mg
0100 Cl
N
O
F F
O H
N F
MM1424.12- N-[2,5-Bis(trifluoromethyl)phenyl]-3-oxo-4-aza-5 - H
164656-22-8 25mg H
F
0025 androstane-17 -carboxamide (Dihydrodutasteride) H
F F
O N
H H
O
OH
MM1424.14- O
H
17 -Carboxy-5-oxo-A-nor-3,5-secoandrostan-3-oic Acid 76763-14-9 25mg HO
0025 H H
O
O
OH
MM1424.15- H
3-Oxo-4-azaandrost-5-ene-17 -carboxylic Acid 103335-54-2 25mg H
0025 H
O N
H
O H
N
O H
N
MM0415.08- H
3-Oxo-N-phenyl-4-aza-5 -androst-1-ene-17 -carboxamide 158522-79-3 25mg H H
0025 O N
H H
Dyclonine Hydrochloride
O
Dydrogesterone
O
Ebastine
MM0468.00-
Ebastine 90729-43-4 250mg O
N
O
0250
OH
OH
MM0490.02-
Impurity A (EP): Diphenylmethanol (Benzhydrol) 91-01-0 25mg
0025
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-209
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
phenyl]-4-(4-hydroxypiperidin-1-yl)butan-1-one
Impurity D (EP): 1-[4-(1,1-Dimethylethyl)phenyl]-
MM0468.05- 4-(4-hydroxypiperidin-1-yl)butan-1-one
N
Related compound D (USP): 1-[4-(1,1-Dimethylethyl)
97928-18-2 25mg
0025 O
HO
phenyl]-4-(4-hydroxypiperidin-1-yl)butan-1-one
Impurity E (EP) as Hydrogen Fumarate: 1-[4-(1,1-
MM0468.06- Dimethylpropyl)phenyl]-4-[4-(diphenylmethoxy)- N
phenyl]-4-[4-(diphenylmethoxy)piperidin-1-yl]-butan-1-one
Mixture of Impurity F and G (EP): Ebastine N-Oxide (cis O
N
+
Ecamsule
Echinomycin
N
N
MM3695.01-
Methyl Quinoxaline-2-carboxylate 1865-11-8 25mg N
O
0025 O
Econazole
Cl
Cl
MM3432.00 Econazole 27220-47-9 250mg
O
N
Cl
N
Econazole Nitrate
Cl
O
MM0524.00- Cl
Econazole Nitrate 24169-02-6 250mg O
HO N
+
O
0250 Cl
N
imidazole-1-yl)ethanol
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-210
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
imidazole-1-yl)ethanol
Impurity B (EP) as Nitrate: (2RS)-2-[(4- Cl
Chlorobenzyl)oxy]-2-(2,4-
MM0524.02 dichlorophenyl)ethanamine Nitrate n/a 100mg Cl
HO N
O
+
O
Related compound B (USP): 2-[(4-Chlorobenzyl)oxy]-2-(2,4- Cl
N H2
O
dichlorophenyl)ethanamine
Impurity B (EP) as Nitrate: (2RS)-2-[(4- Cl
MM0524.02- Chlorobenzyl)oxy]-2-(2,4-
dichlorophenyl)ethanamine Nitrate n/a 25mg Cl
HO N
O
+
O
0025 Related compound B (USP): 2-[(4-Chlorobenzyl)oxy]-2-(2,4- Cl
N H2
O
dichlorophenyl)ethanamine
Impurity C (EP) as Chloride: 1-(4-Chlorobenzyl)-3- Cl
[(2RS)-2-[(4-chlorobenzyl)oxy]-2-(2,4-dichloro- Cl
[(4-chlorobenzyl)oxy]-2-(2,4-dichlorophenyl)ethyl]imidazolium
Impurity C (EP) as Chloride: 1-(4-Chlorobenzyl)-3- Cl
MM0524.03- [(2RS)-2-[(4-chlorobenzyl)oxy]-2-(2,4-dichloro- Cl
[(4-chlorobenzyl)oxy]-2-(2,4-dichlorophenyl)ethyl]imidazolium
Edaravone
O
Edaravone (5-Methyl-2-phenyl-2,4-dihydro-3H-pyrazol-3- N
MM0036.01 89-25-8 100mg
one) N
Edoxaban
N N
O
S O
HN
H
N N
O
O
Cl
Efavirenz
H
N O
O
Cl
MM0919.00 Efavirenz 154598-52-4 250mg F
F
F
O
H
N
MM0919.02- (S)-5-Chloro-a-(2-cyclopropylethynyl)-2-[[(4-methoxyphenyl) Cl
OH
173676-60-3 25mg F
0025 methyl]amino]-a-(trifluoro-methyl)benzenemethanol F
F
N H2
(S)-2-(2-Amino-5-chlorophenyl)-4-cyclopropyl-1,1,1-
OH
Cl
trifluorobut-3-yn-2-ol F
MM0919.03 209414-27-7 100mg F
Related compound A (USP): (S)-2-(2-amino-5-chlorophenyl)- F
4-cyclopropyl-1,1,1-trifluorobut-3-yn-2-ol
N H2
(S)-2-(2-Amino-5-chlorophenyl)-4-cyclopropyl-1,1,1-
OH
Cl
MM0919.03- trifluorobut-3-yn-2-ol F
209414-27-7 25mg F
0025 Related compound A (USP): (S)-2-(2-amino-5-chlorophenyl)- F
4-cyclopropyl-1,1,1-trifluorobut-3-yn-2-ol
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-211
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
N
6-Chloro-2-cyclopropyl-4-(trifluoromethyl)quinoline
MM0919.05 Related compound C (USP): 6-chloro-2-cyclopropyl-4- 391860-73-4 100mg Cl
F
(trifluoromethyl)quinoline F
F
N
6-Chloro-2-cyclopropyl-4-(trifluoromethyl)quinoline
MM0919.05-
Related compound C (USP): 6-chloro-2-cyclopropyl-4- 391860-73-4 25mg Cl
0025 F
(trifluoromethyl)quinoline F
F
H
N O
O
MM0919.06- Cl
F
Efavirenz Racemic 177530-93-7 25mg
0025 F
F
O
H
N
O
H
N
MM0919.07-
N-(4-Methoxybenzyl)-4-chloro-2-(trifluoroacetyl)aniline 173676-54-5 25mg O
Cl
0025 F
F
F
N H2
MM0919.08- O
1-(2-Amino-5-chlorophenyl)-2,2,2-trifluoroethanone 154598-53-5 25mg Cl
0025 F
F
F
Eletriptan Hydrobromide
H
N
Eliglustat Tartrate
N
H
N
MM3942.00- O
Eliglustat 491833-29-5 250mg HO
0250 O
O
Elvitegravir
O O F
Cl
HO
O O
I
O
MM3372.07- Ethyl 7-Fluoro-1-((2S)-1-hydroxy-3-methylbutan-2-yl)-6-iodo-
697762-60-0 25mg N F
0025 4-oxo-1,4-dihydroquinoline-3-carboxylate HO
Embutramide
O
Emedastine Difumarate
O
N
N
N
HO
O
O
OH
O
O
+
N
MM1277.09- N N
O
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-212
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
Empagliflozin
Cl O
MM3780.00- O
Empagliflozin
O
HO
864070-44-0 250mg HO OH
0250 OH
Emtricitabine
F
H 2N
O S OH
N H2
F
N
Emtricitabine L-Menthyl Ester ((2R,5S)-5-(4-Amino-5-fluoro-2-
O N
MM1325.01 oxo-1(2H)-pyrimidinyl)-1,3-oxathiolane-2-carboxylic Acid 764659-72-5 100mg O
(1R,2S,5R)-5-Methyl-2-(1-methylethyl)cyclohexyl Ester) S
O
O
N H2
F
N
Emtricitabine L-Menthyl Ester ((2R,5S)-5-(4-Amino-5-fluoro-2-
MM1325.01- O N
oxo-1(2H)-pyrimidinyl)-1,3-oxathiolane-2-carboxylic Acid 764659-72-5 25mg O
0025
(1R,2S,5R)-5-Methyl-2-(1-methylethyl)cyclohexyl Ester) S
O
O
NH2
F
N
O N
MM1325.02 Emtricitabine Sulfoxide 152128-77-3 100mg
O
S
O
HO
NH2
F
N
MM1325.02- O N
Emtricitabine Sulfoxide 152128-77-3 25mg
0025 O
S
O
HO
NH2
F
N
MM1325.03- O N
Emtricitabine Sulfone 1161846-23-6 25mg
0025
O
S
O
O
HO
HN
F
N
MM1325.04-
N-Acetylemtricitabine n/a 25mg O N
0025
O
S
HO
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-213
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
N H2
F
N
O N
MM1325.05-
O-Acetylemtricitabine 145032-08-2 25mg O
0025
S
O
O
HN
F
N
O N
MM1325.06-
N,O-Diacetylemtricitabine n/a 25mg
0025 O
S
O
O
O
MM1325.08- (2R,5S)-5-Acetyloxy-1,3-oxathiolane-2-carboxylic Acid
147126-65-6 25mg O
0025 (1R,2S,5R)-5-Methyl-2-(1-methylethyl)cyclohexyl Ester S
O
O
NH2
F
N
O N
MM1325.09-
O-Formylemtricitabine n/a 25mg O
0025
S
NH2
F
N
MM0355.00 Flucytosine 2022-85-7 250mg
O N
H
Emylcamate
O
MM3364.00 Emylcamate 78-28-4 50mg
O NH2
Enalapril Maleate
O
O OH O
H
MM0010.00- N
0250 O
O
H
Impurity B (EP): (2S)-2-[[(1S)-1-(Ethoxycarbonyl)- N
OH
MM0010.05 82717-96-2 100mg
3-phenylpropyl]amino]propanoic Acid O O
O
H
MM0010.05- Impurity B (EP): (2S)-2-[[(1S)-1-(Ethoxycarbonyl)- N
OH
82717-96-2 25mg
0025 3-phenylpropyl]amino]propanoic Acid O O
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-214
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
1,4-dioxohexahydropyrrolo[1,2-a]pyrazin-2(1H)-yl]-4-
phenylbutanoate
Impurity D (EP): Ethyl (2S)-2-[(3S,8aS)-3-Methyl-
H
1,4-dioxo-octahydropyrrolo[1,2-a]pyrazin-2-yl]- O
N
MM0010.06- 4-phenylbutanoate (Enalapril Diketopiperazine) N
O
1,4-dioxohexahydropyrrolo[1,2-a]pyrazin-2(1H)-yl]-4-
phenylbutanoate
H
N
MM0015.02 Impurity I (EP): 1H-Imidazole (Imidazole) 288-32-4 100mg
N
(2S)-2-[[(1S)-1-(Ethoxycarbonyl)-3- H
N
O
O
MM0010.15 phenylpropyl]amino]propanoic Acid n/a 100mg O O
HCl
Ethyl Ester Hydrochloride
MM0010.15- (2S)-2-[[(1S)-1-(Ethoxycarbonyl)-3- H
N
O
O
phenylpropyl]amino]propanoic Acid n/a 25mg O O
HCl
0025 Ethyl Ester Hydrochloride
O
O O
H
Enalapril Ethyl Ester (N-[(1S)-1-(Ethoxycarbonyl)-3- N
N
MM0010.17 87420-38-0 100mg O O
phenylpropyl]-L-alanyl-L-proline Ethyl Ester)
OH
MM0010.20 Hydrocinnamic Acid (3-Phenylpropanoic Acid) 501-52-0 100mg
O
O
O OH
MM0010.27- (2S)-1-[(2S)-2-Aminopropanoyl]pyrrolidine-2-carboxylic Acid H2 N
13485-59-1 25mg N
0025 (L-Alanyl-L-proline)
Enilconazole
Cl
Cl
MM1228.00 Enilconazole 35554-44-0 250mg
O
N
Cl
Impurity E (EP): (1RS)-1-(2,4-Dichlorophenyl)-
MM0281.01 24155-42-8 100mg N
2-(1H-imidazol-1-yl)ethanol Cl OH
N
Cl
MM0281.01- Impurity E (EP): (1RS)-1-(2,4-Dichlorophenyl)-
24155-42-8 25mg N
0025 2-(1H-imidazol-1-yl)ethanol Cl OH
N
Enoxacin Sesquihydrate
HN
N N N
Enoxacin Sesquihydrate
H2 O
3
MM3662.00 84294-96-2 250mg F
OH
O O
2
Enoxolone
O
OH
H
O
MM3399.00 Enoxolone 471-53-4 250mg
H
HO
H
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-215
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
Enrofloxacin
N
N N
O O
O O
HN
O O
(Desfluoroenrofloxacin Hydrochloride)
Impurity C (EP) as Hydrochloride: 1-Cyclopropyl- N HCl
MM0395.01- 7-(4-ethylpiperazin-1-yl)-4-oxo-1,4-dihydro- N N
n/a 25mg
0025 quinoline-3-carboxylic Acid Hydrochloride O O
OH
(Desfluoroenrofloxacin Hydrochloride)
O
+
N HCl
N N
MM0395.07 Enrofloxacin N-Oxide Hydrochloride n/a 100mg OH
F
O O
N
MM0395.06 N-Ethylpiperazine 5308-25-8 100mg NH
N
MM0395.11- N N
N
MM0395.12- N N
N
MM0395.13- N N
Ensulizole
H
N
Entacapone
O O
+
N
O N
MM1221.00 Entacapone 130929-57-6 250mg HO
N
OH
MM1221.02- 5-nitrophenyl)-N,N-diethylprop-2-enamide
HO O N
Related compound A (USP): (Z)-2-cyano-3-(3,4-dihydroxy-
145195-63-7 25mg
0025 +
N
O O
5-nitrophenyl)-N,N-diethylacrylamide
O O
+
MM1221.04- Impurity B (EP): Ethyl (2E)-2-Cyano-3-(3,4- O
N
O
1215039-66-9 25mg
0025 dihydroxy-5-nitrophenyl)prop-2-enoate HO
OH
N
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-216
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
O
HO
O
HO
MM1221.01-
Impurity C (EP): 3,4-Dihydroxy-5-nitrobenzaldehyde 116313-85-0 25mg
0025 HO
+
N
O O
O O
O O
+
N
MM1221.07- Impurity F (EP): (2E)-2-Cyano-3-(3,4-dihydroxy- O OH
160391-70-8 25mg
0025 5-nitrophenyl)prop-2-enoic Acid HO
N
OH
O O
+
MM1221.08- Impurity G (EP): (2E)-2-Cyano-3-(3,4-dihydroxy- O
N
N
H
n/a 25mg
0025 5-nitrophenyl)-N-methylprop-2-enamide HO
N
OH
O N
MM1221.03 phenyl)-2-(piperidin-1-ylcarbonyl)prop-2- 1150310-15-8 50mg HO
ennitrile OH
N
O O
O
1364322-42-8 25mg
0025 dihydroxy-5-nitrophenyl)prop-2-enoate HO
OH
N
Entecavir Monohydrate
O
N
HN
H2 O
H 2N N N
MM3314.00 Entecavir Monohydrate 209216-23-9 250mg
HO
HO
N
Impurity D (EP): 2-Amino-9-[(1S,3R,4R)-4-hydroxy-3- HN
MM3314.07- H 2N N N
(hydroxymethyl)-2-methylidenecyclopentyl]-1,9-dihydro-6H- 1367369-80-9 25mg
0025 OH
purin-6-one
HO
N
HN
HN N N
H
MM3314.01 Entecavir N2-Isomer n/a 5mg
HO
HO
N
HN
MM3314.02- H 2N N N
N-[(4-Methoxyphenyl)diphenylmethyl]-9-[(1S,3R,4S)-2- O
MM3314.16- N
N
0025
cyclopentyl]-6-(phenylmethoxy)-9H-purin-2-amine O
O
O
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-217
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
Enzalutamide
F
F
O F F
N
MM3917.00- N
H
S
Ephedrine Hydrochloride
OH
H
MM0652.00- N
Ephedrine Hydrochloride 50-98-6 250mg HCl
0250
Impurity B (EP) as Hydrochloride: (1S,2S)-2- OH
MM2115.00- NH HCl
(Methylamino)-1-phenylpropan-1-ol Hydro- 345-78-8 250mg
0250 chloride (Pseudoephedrine Hydrochloride)
OH
H
N HCl
MM0652.03 (1S,2R)-(+)-Ephedrine Hydrochloride 24221-86-1 100mg
OH
H
MM0652.03- N HCl
(1S,2R)-(+)-Ephedrine Hydrochloride 24221-86-1 25mg
0025
OH
N
MM0652.04 Methylephedrine ((1R,2S)-Methylephedrine) 552-79-4 100mg
OH
MM0652.04- N
Methylephedrine ((1R,2S)-Methylephedrine) 552-79-4 25mg
0025
OH O
+
N
MM0652.05 2-Nitro-1-phenyl-1-propanol 6343-57-3 100mg O
Ephedrine Sulphate
OH
H O
N
MM1147.00 Ephedrine Sulphate 134-72-5 250mg HO
O
S OH
Epinastine Hydrochloride
N
NH2
N
MM3383.00 Epinastine Hydrochloride 108929-04-0 250mg HCl
Epirubicin Hydrochloride
O OH O
OH
OH
NH2
OH
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-218
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
O OH
O
OH
MM0283.01-
Impurity A (EP): Doxorubicinone 24385-10-2 25mg OH
0025 O O OH OH
O OH O
OH
OH
NH2
OH
O OH O
OH
NH2
OH
Eplerenone
O
O H
MM3530.00 Eplerenone 107724-20-9 250mg H
O
O
O
Eprosartan Mesilate
O O O
S
OH OH
O
MM1577.00 Eprosartan Mesilate 144143-96-4 250mg HO
N
S N
O O
2-(Thiophen-2-ylmethyl)malonic Acid
MM1577.01- HO OH
Related compound C (USP): 2-(thiophen-2-ylmethyl)malonic 4475-24-5 25mg S
0025
acid
3-(Thiophen-2-yl)propanoic Acid HO
MM1577.02 5928-51-8 100mg
Related compound B (USP): 3-(thiophen-2-yl)propanoic acid S
Eptifibatide
HN N H2 NH
O
HN H
O N O O
N
H O
OH N OH
MM3543.01 Eptifibatide Acetate 881997-86-0 100mg HN
O
O
NH
N H2
HN S S O
O
Equilin
O
Erdosteine
O
S
MM0544.00- O O
Erdosteine 84611-23-4 250mg N
S
OH
0250 H
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-219
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
O
S
O
MM0544.01- 2-Chloro-N-(2-oxotetrahydrothiophen-3-
Cl
yl)acetamide
84611-22-3 25mg
0025 N
H
O
S
O O
MM0544.02 Erdosteine Methyl Ester 1667709-77-4 100mg S
N O
H
O
S
MM0544.02- O O
O
S
MM0544.03- O O
O
S
MM0544.04- O O
O O
Methyl 2-[[2-(2-Methoxy-2-oxoethyl)sulfanylacetyl]amino]-4- O O
S
MM0544.05 n/a 100mg HS N
H
O
sulfanylbutanoate
O O
Ethyl 2-[[2-(2-Ethoxy-2-oxo-ethyl)sulfanylacetyl]amino]-4- O O
S
MM0544.06 n/a 100mg HS N
H
O
sulfanylbutanoate
O
S
MM0544.08- O O O
Erdosteine Sulfoxide n/a 25mg S
N OH
0025 H
Ergocalciferol
HO
MM1511.01- H
O O
HO N
H
Impurity A (EP): (8 )-6-Methyl-9,10-didehydroergoline-8-
MM1346.03 82-58-6 100mg
carboxylic Acid (Lysergic Acid)
N
H
HO N
H
MM1346.03- Impurity A (EP): (8 )-6-Methyl-9,10-didehydroergoline-8-
82-58-6 25mg
0025 carboxylic Acid (Lysergic Acid)
N
H
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-220
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
Ergotamine Tartrate
H
N
HN OH
MM0097.06 Lysergol 602-85-7 100mg
H
N
MM0097.06- HN
Lysergol 602-85-7 25mg OH
0025
Erlotinib Hydrochloride
O N
O
O N
O N
O
O N
MM3297.01 4-Chloro-6,7-bis(2-methoxyethoxy)quinazoline 183322-18-1 100mg O
Cl
O N
O
MM3297.01- O N
4-Chloro-6,7-bis(2-methoxyethoxy)quinazoline 183322-18-1 25mg O
0025 Cl
O N
O
O NH
MM3297.02 6,7-Bis(2-methoxyethoxy)-3H-quinazolin-4-one 179688-29-0 100mg O
O
O N
O
MM3297.02- O NH
6,7-Bis(2-methoxyethoxy)-3H-quinazolin-4-one 179688-29-0 25mg O
0025 O
O NH2
O
MM3297.04- 2-Amino-4,5-bis(2-methoxyethoxy)benzoic Acid Ethyl Ester HCl
O O
183322-17-0 25mg O
O
0025 Hydrochloride
O
MM3297.05- O
O
MM3297.06- O
3,4-Bis(2-methoxyethoxy)benzaldehyde 80407-64-3 100mg O O
0100 O
O
+
MM3297.07- O N
O O
4,5-Bis(2-methoxyethoxy)-2-nitrobenzonitrile 236750-65-5 25mg O
0025 O
N
OH
MM3297.08- H2 N
4-(3-Aminophenyl)-2-methylbut-3-yn-2-ol 69088-96-6 25mg
0025
O
O
MM3297.09- O O
3,4-Bis(2-methoxyethoxy)benzoic Acid Ethyl Ester 183322-16-9 25mg O
0025 O
HO
MM3297.10-
3,4-Dihydroxybenzaldehyde 139-85-5 25mg O
0025 HO
O NH2
MM3297.13- O
2-Amino-4,5-bis(2-methoxyethoxy)benzonitrile 950596-58-4 25mg O
O
0025 N
O N
O
O N
MM3297.19- N-(4-Ethynylphenyl)-6,7-bis(2-methoxyethoxy)-4- O
HN
1029721-32-1 25mg
0025 quinazolinamine
O N
O
MM3297.17- O N
O
4-(1,1-Dimethylethoxy)-6,7-bis(2-methoxyethoxy)quinazoline 1683583-42-7 25mg O
0025
O N
O
MM3297.16- O N
O
6,7-Bis(2-methoxyethoxy)-4-(1-methylethoxy)quinazoline 1683583-39-2 25mg O
0025
O N
O
MM3297.18- O N
6,7-Bis(2-methoxyethoxy)-4-quinazolinamine 1417161-98-8 25mg O
0025 N H2
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-221
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
Erythritol
OH
OH
HO OH
O
Impurity A (EP): 4-O- -D-Glucopyranosyl-D-glucitol (D- HO O
MM3570.00 585-88-6 250mg OH
Maltitol) HO OH
HO
OH
OH
OH
HO
MM1492.00 Impurity B (EP): D-Glucitol (D-Sorbitol, Sorbitol) 50-70-4 250mg OH
OH
HO
Erythromycin
[(2,6-Dideoxy-3-C-methyl-3-O-methyl- -L-ribo-hexopyranosyl) O HO HO
OH
oxy]-14-ethyl-7,12,13-trihydroxy-3,5,7,9,11,13-hexamethyl-6- O O
MM0132.13 992-62-1 100mg
[[3,4,6-trideoxy-3-(methylamino)- -D-xylo-hexopyranosyl]oxy] N
H
OH
O
O O
oxacyclotetradecane-2,10-dione (3''-N- HO
O
Desmethylerythromycin A; N-Demethylerythromycin A)
[(2,6-Dideoxy-3-C-methyl-3-O-methyl- -L-ribo-hexopyranosyl) O HO HO
OH
MM0132.13- oxy]-14-ethyl-7,12,13-trihydroxy-3,5,7,9,11,13-hexamethyl-6- O O
992-62-1 25mg
0025 [[3,4,6-trideoxy-3-(methylamino)- -D-xylo-hexopyranosyl]oxy] N
H
OH
O
O O
oxacyclotetradecane-2,10-dione (3''-N- HO
O
Desmethylerythromycin A; N-Demethylerythromycin A)
Impurity D (EP):
OH
(1S,2R,3R,4S,5R,8R,9S,10S,11R,12R,14R)-9-[(2,6-Dideoxy-
O
trioxatricyclo[10.2.1.11,4]hexadecan-7-one
O
(Anhydroerythromycin A)
Impurity E (EP): (2R,3R,4S,5R,8R,9S,10S,11R,12R)-9-[(2,6-
Dideoxy-3-C-methyl-3-O-methyl- -L-ribo-hexopyranosyl)oxy]- O
O
HO
OH
MM0132.10- 5-ethyl-3,4-dihydroxy-2,4,8,10,12,14-hexamethyl-11-[[3,4,6- O O
33396-29-1 25mg
0025 trideoxy-3-(dimethylamino)- -D-xylo-hexopyranosyl]oxy]- N OH O
O
O
6,15-dioxabicyclo[10.2.1]pentadec-1(14)-en-7-one HO
O
N [(2,6-Dideoxy-3-C-methyl-3-O-methyl- -L-ribo-hexopyranosyl) O HO HO
OH
MM0132.18- oxy]-14-ethyl-7,12,13-trihydroxy-3,5,7,9,11,13-hexamethyl-6- +
O O
e 992-65-4 25mg
0025 [[3,4,6-trideoxy-3-(dimethylamino)- -D-xylo-hexopyranosyl] N
O
OH
O
O O
(1S,2R,3R,6R,7S,8S,9R,10R,12R)-7-[(2,6-Dideoxy-3-C- O OH
methyl-3-O-methyl- -L-ribo-hexopyranosyl)oxy]-3-[(1R,2R)- O
H
O
O HO
MM0132.25 1,2-dihydroxy-1-methylbutyl]-1-hydroxy-2,6,8,10,12- 105900-46-7 50mg N OH O
O
O
pentamethyl-9-[[3,4,6-trideoxy-3-(dimethylamino)- -D-xylo-
HO
hexopyranosyl]oxy]-4,13-dioxabicyclo[8.2.1]tridecan-5-one O
(Pseudoerythromycin A Hemiketal)
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-222
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
Erythromycin Estolate
Impurity B (EP): (3R,4S,5S,6R,7R,9R,11R,12R,13S,14R)-4- O
[(2,6-Dideoxy-3-C-methyl-3-O-methyl- -L-ribo-hexopyranosyl) O HO HO
OH
oxy]-14-ethyl-7,12,13-trihydroxy-3,5,7,9,11,13-hexamethyl-6- O O
MM0132.13 992-62-1 100mg
[[3,4,6-trideoxy-3-(methylamino)- -D-xylo-hexopyranosyl]oxy] N
H
OH
O
O O
oxacyclotetradecane-2,10-dione (3''-N- HO
O
Desmethylerythromycin A; N-Demethylerythromycin A)
Impurity B (EP): (3R,4S,5S,6R,7R,9R,11R,12R,13S,14R)-4- O
[(2,6-Dideoxy-3-C-methyl-3-O-methyl- -L-ribo-hexopyranosyl) O HO HO
OH
MM0132.13- oxy]-14-ethyl-7,12,13-trihydroxy-3,5,7,9,11,13-hexamethyl-6- O O
992-62-1 25mg
0025 [[3,4,6-trideoxy-3-(methylamino)- -D-xylo-hexopyranosyl]oxy] N
H
OH
O
O O
oxacyclotetradecane-2,10-dione (3''-N- HO
O
Desmethylerythromycin A; N-Demethylerythromycin A)
Impurity D (EP):
OH
(1S,2R,3R,4S,5R,8R,9S,10S,11R,12R,14R)-9-[(2,6-Dideoxy-
O
trioxatricyclo[10.2.1.11,4]hexadecan-7-one
O
(Anhydroerythromycin A)
Impurity E (EP): (2R,3R,4S,5R,8R,9S,10S,11R,12R)-9-[(2,6-
Dideoxy-3-C-methyl-3-O-methyl- -L-ribo-hexopyranosyl)oxy]- O
O
HO
OH
MM0132.10- 5-ethyl-3,4-dihydroxy-2,4,8,10,12,14-hexamethyl-11-[[3,4,6- O O
33396-29-1 25mg
0025 trideoxy-3-(dimethylamino)- -D-xylo-hexopyranosyl]oxy]- N OH O
O
O
6,15-dioxabicyclo[10.2.1]pentadec-1(14)-en-7-one HO
O
N [(2,6-Dideoxy-3-C-methyl-3-O-methyl- -L-ribo-hexopyranosyl) O HO HO
OH
e
MM0132.18- oxy]-14-ethyl-7,12,13-trihydroxy-3,5,7,9,11,13-hexamethyl-6- +
O O
992-65-4 25mg
0025 [[3,4,6-trideoxy-3-(dimethylamino)- -D-xylo-hexopyranosyl] N
O
OH
O
O O
(1S,2R,3R,6R,7S,8S,9R,10R,12R)-7-[(2,6-Dideoxy-3-C- O OH
methyl-3-O-methyl- -L-ribo-hexopyranosyl)oxy]-3-[(1R,2R)- O
H
O
O HO
MM0132.25 1,2-dihydroxy-1-methylbutyl]-1-hydroxy-2,6,8,10,12- 105900-46-7 50mg N OH O
O
O
pentamethyl-9-[[3,4,6-trideoxy-3-(dimethylamino)- -D-xylo-
HO
hexopyranosyl]oxy]-4,13-dioxabicyclo[8.2.1]tridecan-5-one O
(Pseudoerythromycin A Hemiketal)
Erythromycin Ethylsuccinate
Impurity B (EP): (3R,4S,5S,6R,7R,9R,11R,12R,13S,14R)-4- O
[(2,6-Dideoxy-3-C-methyl-3-O-methyl- -L-ribo- OH
O HO HO
hexopyranosyl)oxy]-14-ethyl-7,12,13-trihydroxy- O O
MM0132.13 992-62-1 100mg N
H
OH O O
3,5,7,9,11,13-hexamethyl-6-[[3,4,6-trideoxy-3-(methylamino)- O
HO
-D-xylo-hexopyranosyl]oxy]oxacyclotetradecane-2,10-dione O
(3''-N-Desmethylerythromycin A; N-Demethylerythromycin A)
Impurity B (EP): (3R,4S,5S,6R,7R,9R,11R,12R,13S,14R)-4- O
[(2,6-Dideoxy-3-C-methyl-3-O-methyl- -L-ribo- OH
O HO HO
MM0132.13- hexopyranosyl)oxy]-14-ethyl-7,12,13-trihydroxy- O O
992-62-1 25mg N
H
OH O O
0025 3,5,7,9,11,13-hexamethyl-6-[[3,4,6-trideoxy-3-(methylamino)- O
HO
-D-xylo-hexopyranosyl]oxy]oxacyclotetradecane-2,10-dione O
(3''-N-Desmethylerythromycin A; N-Demethylerythromycin A)
Impurity D (EP): (1S,2R,3R,4S,5R,8R,9S,10S,11R,12R,14R)-
OH
9-[(2,6-Dideoxy-3-C-methyl-3-O-methyl- -L-ribo- O
O O
O O
MM0132.09- hexopyranosyl)oxy]-5-ethyl-3-hydroxy-2,4,8,10,12,14-
23893-13-2 25mg N OH O O
O
0025 hexamethyl-11-[[3,4,6-trideoxy-3-(dimethylamino)- -D-xylo-
HO
O
hexopyranosyl]oxy]-6,15,16-trioxatricyclo[10.2.1.11,4]
hexadecan-7-one (Anhydroerythromycin A)
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-223
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
MM0132.10- 5-ethyl-3,4-dihydroxy-2,4,8,10,12,14-hexamethyl-11-[[3,4,6- O O
33396-29-1 25mg N OH O O
0025 trideoxy-3-(dimethylamino)- -D-xylo-hexopyranosyl]oxy]- O
HO
6,15-dioxabicyclo[10.2.1]pentadec-1(14)-en-7-one O
Erythromycin Lactobionate
[(2,6-Dideoxy-3-C-methyl-3-O-methyl- -L-ribo-hexopyranosyl) O HO HO
OH
oxy]-14-ethyl-7,12,13-trihydroxy-3,5,7,9,11,13-hexamethyl-6- O O
MM0132.13 992-62-1 100mg
[[3,4,6-trideoxy-3-(methylamino)- -D-xylo-hexopyranosyl]oxy] N
H
OH
O
O O
oxacyclotetradecane-2,10-dione (3''-N- HO
O
Desmethylerythromycin A; N-Demethylerythromycin A)
[(2,6-Dideoxy-3-C-methyl-3-O-methyl- -L-ribo-hexopyranosyl) O HO HO
OH
MM0132.13- oxy]-14-ethyl-7,12,13-trihydroxy-3,5,7,9,11,13-hexamethyl-6- O O
992-62-1 25mg
0025 [[3,4,6-trideoxy-3-(methylamino)- -D-xylo-hexopyranosyl]oxy] N
H
OH
O
O O
oxacyclotetradecane-2,10-dione (3''-N- HO
O
Desmethylerythromycin A; N-Demethylerythromycin A)
Impurity D (EP):
OH
(1S,2R,3R,4S,5R,8R,9S,10S,11R,12R,14R)-9-[(2,6-Dideoxy-
O
trioxatricyclo[10.2.1.11,4]hexadecan-7-one
O
(Anhydroerythromycin A)
Impurity E (EP): (2R,3R,4S,5R,8R,9S,10S,11R,12R)-9-[(2,6-
Dideoxy-3-C-methyl-3-O-methyl- -L-ribo-hexopyranosyl)oxy]- O
O
HO
OH
MM0132.10- 5-ethyl-3,4-dihydroxy-2,4,8,10,12,14-hexamethyl-11-[[3,4,6- O O
33396-29-1 25mg
0025 trideoxy-3-(dimethylamino)- -D-xylo-hexopyranosyl]oxy]- N OH O
O
O
6,15-dioxabicyclo[10.2.1]pentadec-1(14)-en-7-one HO
O
N [(2,6-Dideoxy-3-C-methyl-3-O-methyl- -L-ribo-hexopyranosyl) O HO HO
OH
MM0132.18- oxy]-14-ethyl-7,12,13-trihydroxy-3,5,7,9,11,13-hexamethyl-6- +
O O
e 992-65-4 25mg
0025 [[3,4,6-trideoxy-3-(dimethylamino)- -D-xylo-hexopyranosyl] N
O
OH
O
O O
(1S,2R,3R,6R,7S,8S,9R,10R,12R)-7-[(2,6-Dideoxy-3-C- O OH
methyl-3-O-methyl- -L-ribo-hexopyranosyl)oxy]-3-[(1R,2R)- O
H
O
O HO
MM0132.25 1,2-dihydroxy-1-methylbutyl]-1-hydroxy-2,6,8,10,12- 105900-46-7 50mg N OH O
O
O
pentamethyl-9-[[3,4,6-trideoxy-3-(dimethylamino)- -D-xylo-
HO
hexopyranosyl]oxy]-4,13-dioxabicyclo[8.2.1]tridecan-5-one O
(Pseudoerythromycin A Hemiketal)
Erythromycin Stearate
Impurity B (EP): (3R,4S,5S,6R,7R,9R,11R,12R,13S,14R)-4-
O
[(2,6-Dideoxy-3-C-methyl-3-O-methyl- -L-ribo-
OH
hexopyranosyl)oxy]-14-ethyl-7,12,13-trihydroxy- O HO HO
O O
MM0132.13 3,5,7,9,11,13-hexamethyl-6-[[3,4,6-trideoxy-3-(methylamino)- 992-62-1 100mg N
H
OH O O
O
-D-xylo-hexopyranosyl]oxy]oxacyclotetradecane-2,10-dione HO
O
(3''-N-Desmethylerythromycin A; N-Demethylerythromycin A)
Related compound N (USP): N-Demethylerythromycin A
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-224
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
MM0132.13- O O
3,5,7,9,11,13-hexamethyl-6-[[3,4,6-trideoxy-3-(methylamino)- 992-62-1 25mg N
H
OH O O
0025 O
-D-xylo-hexopyranosyl]oxy]oxacyclotetradecane-2,10-dione HO
O
(3''-N-Desmethylerythromycin A; N-Demethylerythromycin A)
Related compound N (USP): N-Demethylerythromycin A
Impurity D (EP): (1S,2R,3R,4S,5R,8R,9S,10S,11R,12R,14R)-
OH
9-[(2,6-Dideoxy-3-C-methyl-3-O-methyl- -L-ribo- O
O O
O O
MM0132.09- hexopyranosyl)oxy]-5-ethyl-3-hydroxy-2,4,8,10,12,14-
23893-13-2 25mg N OH O O
O
0025 hexamethyl-11-[[3,4,6-trideoxy-3-(dimethylamino)- -D-xylo-
HO
O
hexopyranosyl]oxy]-6,15,16-trioxatricyclo[10.2.1.11,4]
hexadecan-7-one (Anhydroerythromycin A)
Impurity E (EP): (2R,3R,4S,5R,8R,9S,10S,11R,12R)-9-[(2,6-
Dideoxy-3-C-methyl-3-O-methyl- -L-ribo-hexopyranosyl)oxy]- O OH
O HO
MM0132.10- 5-ethyl-3,4-dihydroxy-2,4,8,10,12,14-hexamethyl-11-[[3,4,6- O O
33396-29-1 25mg N OH O O
0025 trideoxy-3-(dimethylamino)- -D-xylo-hexopyranosyl]oxy]- O
HO
6,15-dioxabicyclo[10.2.1]pentadec-1(14)-en-7-one O
N [(2,6-Dideoxy-3-C-methyl-3-O-methyl- -L-ribo-hexopyranosyl) O HO HO
OH
MM0132.18- oxy]-14-ethyl-7,12,13-trihydroxy-3,5,7,9,11,13-hexamethyl-6- +
O O
e 992-65-4 25mg
0025 [[3,4,6-trideoxy-3-(dimethylamino)- -D-xylo-hexopyranosyl] N
O
OH
O
O O
(1S,2R,3R,6R,7S,8S,9R,10R,12R)-7-[(2,6-Dideoxy-3-C- O OH
methyl-3-O-methyl- -L-ribo-hexopyranosyl)oxy]-3-[(1R,2R)- O
H
O
O HO
MM0132.25 1,2-dihydroxy-1-methylbutyl]-1-hydroxy-2,6,8,10,12- 105900-46-7 50mg N OH O
O
O
pentamethyl-9-[[3,4,6-trideoxy-3-(dimethylamino)- -D-xylo-
HO
hexopyranosyl]oxy]-4,13-dioxabicyclo[8.2.1]tridecan-5-one O
(Pseudoerythromycin A Hemiketal)
Escitalopram Oxalate
F
O OH
O OH
F
Impurity A (EP): (1RS)-1-[3-(Dimethylamino)propyl]-1-(4-
MM0242.14- fluorophenyl)-1,3-dihydro-2-benzofuran-5-carboxamide
64372-56-1 25mg N
0025 ((1RS)-1-[3-(Dimethylamino)propyl]-1-(4-fluorophenyl)-1,3- O
H2 N
O
dihydroisobenzofuran-5-carboxamide; Citalopram-Amide)
Impurity B (EP) as Oxalate: 1-[3-(Dimethylamino)propyl]-1-(4-
F
fluorophenyl)-3-hydroxy-1,3-dihydro-2-benzofuran-5-
MM0242.21- O OH
N O
fluorophenyl)isobenzofuran-1(3H)-one; 3-Oxocitalopram)
F
Impurity C (EP): (1RS)-1-[3-(Dimethylamino)propyl]-1-(4-
MM0242.17- fluorophenyl)-3-oxo-1,3-dihydro-2-benzofuran-5-carbonitrile
372941-54-3 25mg N
0025 ((3RS)-6-Cyano-3-[3-(dimethylamino)propyl]-3-(4- O
N O
fluorophenyl)isobenzofuran-1(3H)-one; 3-Oxocitalopram)
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-225
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
0025 N O
propyl]-3-(4-fluorophenyl)isobenzofuran-1(3H)-one Oxalate;
3-Oxocitalopram Oxalate)
Impurity D (EP) as Hydrochloride: (1RS)-1-(4-Fluorophenyl)-
F
1-[3-(methylamino)propyl]-1,3-dihydro-2-benzofuran-5-
MM0242.09- HCl
carbonitrile Hydrochloride ((1RS)-1-(4-Fluorophenyl)-1-[3- 97743-99-2 25mg N
H
0025 O
(methylamino)propyl]-1,3-dihydro-2-benzofuran-5-carbonitrile N
Hydrobromide)
Impurity E (EP) as S-Enantiomer Ditoluoyltartrate: (4S)-4-[4-
Cyano-2-(hydroxymethyl)phenyl]-4-(4-fluorophenyl)-4-
hydroxy-N,N-dimethylbutan-1-amine (2S,3S)-2,3-Bis[(4-
methylbenzoyl)oxy]butanedioate (2:1) ((S)-Citadiol Di-p- F
O OH
MM1162.04- O
O
O
N
toluoyl-D-tartrate Salt (2:1); 4-[(1S)-4-(Dimethylamino)-1-(4- 128173-53-5 25mg N
OH O
HO O
OH
0025 2
fluorophenyl)-1-hydroxybutyl]-3-(hydroxymethyl)benzonitrile
Hemi-(+)-di-p-toluoyltartrate)
Related compound A (USP): (S)-4-[4-dimethylamino-1-(4-
fluoropheny)-1-hydroxy-1-butyl]-3-hydroxymethylbenzonitrile
Impurity E (EP) as S-Enantiomer free base: (4S)-4-[4-Cyano- F
2-(hydroxymethyl)phenyl]-4-(4-fluorophenyl)-4-hydroxy-N,N-
MM1162.06-
dimethylbutan-1-amine Hydrobromide ((S)-Citadiol) 488787-59-3 25mg N
0025 OH
Related compound A (USP): (S)-4-[4-dimethylamino-1-(4- N
OH
fluoropheny)-1-hydroxy-1-butyl]-3-hydroxymethylbenzonitrile
OH
MM1162.11- Impurity F (EP): (1RS)-1-[3-(Dimethylamino)propyl]-1- N
O
2102609-59-4 25mg
0025 hydroxy-1,3-dihydro-2-benzofuran-5-carbonitrile N
N
n/a 25mg O
HBr
2
0025 (Dimethylamino)-1-[(1RS)-1-[3-(dimethylamino)propyl]-1-(4- O
fluorophenyl)-1,3-dihydroisobenzofuran-5-yl]butan-1-one
Dihydrobromide)
F
O O
dimethylpropan-1-amine N-Oxide (Escitalopram N-Oxide) N
O O
Impurity J (EP) as Hydrate: 4-Methylbenzenesulfonic Acid S
OH H2O
MM0598.02 6192-52-5 100mg
Hydrate (p-Toluenesulfonic Acid Hydrate)
F
Impurity K (EP) as Oxalate: (1R)-1-[3-(Dimethylamino)
MM1162.03- O OH
MM0242.29-
1-(4-Fluorophenyl)-1,3-dihydroisobenzofuran-5-carbonitrile 64169-67-1 25mg
0025
O
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-226
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
O O
HO OH
O O
MM1497.03- O O
(+)-Di-p-toluoyl-D-(+)-tartaric Acid 32634-68-7 25mg
0025
Esflurbiprofen
F OH
Esketamine Hydrochloride
O
Cl
MM3764.00- NH
HCl
Esketamine Hydrochloride 33643-47-9 100mg
0100
O
Eslicarbazepine Acetate
O
N N H2
MM3544.00 Eslicarbazepine Acetate 236395-14-5 100mg O
O
N
benzimidazole (Ufiprazole)
N
0025 benzimidazole (Ufiprazole)
Impurity D (EP): 5-Methoxy-2-[[(4-methoxy-3,5- O NH
N
benzimidazole (Omeprazole Sulphone)
N
0025 benzimidazole (Omeprazole Sulphone)
Impurity E (EP): 4-Methoxy-2-[[(RS)-(5-methoxy- O NH
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-227
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
MM0095.10-
2,3,5-Trimethylpyridine N-Oxide 74409-42-0 25mg
0025 +
N
O
MM0095.51- HO
2-Hydroxymethyl-3,5-dimethylpyridine 202932-05-6 100mg
0100 N
Esomeprazole Sodium
O +
N Na
O N
O NH
MM0095.03 Impurity A (EP): 5-Methoxy-1H-benzimidazole-2-thiol 37052-78-1 100mg
N SH
MM0095.03- O NH
Impurity A (EP): 5-Methoxy-1H-benzimidazole-2-thiol 37052-78-1 25mg
0025 N SH
(Ufiprazole)
Impurity C (EP): 5-Methoxy-2-[[(4-methoxy-3,5- O NH
MM0095.06- O
dimethylpyridin-2-yl)methyl]sulfanyl]-1H-benzimidazole 73590-85-9 25mg N S
0025 N
(Ufiprazole)
Impurity D (EP): 5-Methoxy-2-[(4-methoxy-3,5- O NH
O
MM0095.05 dimethylpyridin-2-yl)methanesulfonyl]-1H-benzimidazole 88546-55-8 100mg N S
O O N
(Omeprazole Sulfone)
Impurity D (EP): 5-Methoxy-2-[(4-methoxy-3,5- O NH
MM0095.05- O
dimethylpyridin-2-yl)methanesulfonyl]-1H-benzimidazole 88546-55-8 25mg N S
O O N
0025
(Omeprazole Sulfone)
Impurity E (EP): 4-Methoxy-2-[[(RS)-5-methoxy-1H- O NH
O
MM0095.07 benzimidazole-2-sulfinyl]methyl]-3,5-dimethylpyridine 1-Oxide 176219-04-8 100mg N S
+
O N
O
(Omeprazole N-Oxide)
Impurity F (EP): 8-Methoxy-1,3-dimethyl-12-
S
O
sulfanylidenepyrido[1',2':3,4]imidazo[1,2-a]benzimidazol-2 N
MM0095.01 125656-82-8 50mg N
(12H)-one (8-Methoxy-1,3-dimethyl-12-thioxopyrido[1',2':3,4] O N
imidazo[1,2-a]benzimidazol-2(12H)-one)
Impurity G (EP): 9-Methoxy-1,3-dimethyl-12-
S
O
sulfanylidenepyrido[1',2':3,4]imidazo[1,2-a]benzimidazol-2 O N
MM0095.02 125656-83-9 50mg N
(12H)-one (9-Methoxy-1,3-dimethyl-12-thioxopyrido[1',2':3,4] N
imidazo[1,2-a]benzimidazol-2(12H)-one)
MM0095.10-
2,3,5-Trimethylpyridine N-Oxide 74409-42-0 25mg
0025 +
N
O
MM0095.51- HO
2-Hydroxymethyl-3,5-dimethylpyridine 202932-05-6 100mg
0100 N
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-228
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
Estazolam
N
N
N
Estradiol Benzoate
OH
OH
983-30-2 25mg H
OH
H
6045-53-0 25mg
0025 trien-3-yl Benzoate (17-epi-Estradiol Benzoate) O
2393-53-5 25mg H H
O
MM0278.01-
Benzoic Acid 65-85-0 250mg OH
0250
Estradiol Cypionate
O
H H
HO
Estradiol Enanthate
O
O
MM0473.00-
Estradiol Enanthate 4956-37-0 250mg H
H H
0250 HO
H
MM0473.01 Estrone 3-Acetate 901-93-9 100mg O
H H
O
MM0473.01- H
Estrone 3-Acetate 901-93-9 25mg O
H H
0025 O
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-229
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
Estradiol Hemihydrate
OH
MM0300.00- H
Estradiol Hemihydrate 35380-71-3 250mg H H
H2 O
0250 HO
2
OH
OH
OH
6171-48-8 25mg
0025 3,17 -diol (4-Methylestradiol) HO
H H
OH
OH
OH
H
MM0300.03-
6 -Hydroxyestradiol 3583-03-7 25mg H H
0025 HO
OH
OH
OH
H
MM0300.04-
6 -Hydroxyestradiol 1229-24-9 25mg H H
0025 HO
OH
OH
6-Ketoestradiol H
diol-6-one HO
O
OH
MM0300.08- 6-Ketoestradiol H
OH
Estra-1,3,5(10),6-tetraene-3,17ß-diol (6,7-Didehydroestradiol)
MM0300.09- H
Related compound B (USP): 1,3,5(10),6-estratetraen- 7291-41-0 25mg
0025 H H
3,17beta-diol HO
O
MM0300.11-
Estradiol 17-Acetate 1743-60-8 25mg H
0025 H H
HO
H H
O
O
MM0300.12-
Estradiol Diacetate 3434-88-6 25mg O
H
0025 H H
O
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-230
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
OH
H
O
MM0300.18 2-Methoxyestradiol 362-07-2 100mg
H H
HO
OH
MM0300.18- O
H
2-Methoxyestradiol 362-07-2 25mg
0025 H H
HO
Estradiol Valerate
O
H H
HO
OH
H
MM0209.06 1,3,5(10)-trien-3-yl Pentanoate 21881-45-8 100mg O
H H
(Estradiol 3-Valerate) O
H
1,3,5(10)-trien-3-yl Pentanoate 21881-45-8 25mg O
H H
0025 (Estradiol 3-Valerate) O
Pentanoate H
HO
(9,11-Didehydroestradiol Valerate)
Impurity C (EP): 3-Hydroxyestra- O
O
MM0209.01- 1,3,5(10),9(11)-tetraen-17 -yl 95959-20-9 25mg H
0025 Pentanoate H
HO
(9,11-Didehydroestradiol Valerate)
O
(4-Methylestradiol Valerate) HO
(4-Methylestradiol Valerate)
0025 HO
(Estradiol 3,17-Divalerate) O
MM0209.02-
3,17 -diyl Dipentanoate 63042-28-4 25mg O
H
H
(Estradiol 3,17-Divalerate)
0025 O
(Estradiol Butyrate) HO
H H
(Estradiol Butyrate)
0025 H H
HO
17-epi-Estradiol Valerate O
182624-54-0 25mg H
O
H H
Cl
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-231
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
OH
H
MM0100.01-
Estramustine 2998-57-4 25mg Cl
N
O
O
H H
0025 Cl
17 -17' -Bis3-{bis(2-
chloroethyl)carbamoyl- +
Na O
O
P
O O
O
P
O Na
O
+
Cl
N
O
O
H
H
H H
H
H
O
O
N
Cl
Cl
trienyl Pyrophosphate
Disodium Salt
Estriol
OH
H OH
MM0130.00 Estriol 50-27-1 100mg H H
HO
3,16alpha,17Beta-triol
Impurity A (EP): Estra-1,3,5(10),9(11)-tetraene- OH
3,16alpha,17Beta-triol
O
OH
OH
OH
OH
OH
OH
OH
OH
OH
OH
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-232
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
OH
H OH
MM0130.02-
6 -Hydroxyestriol 7291-49-8 25mg H H
0025 HO
OH
O
MM0130.14-
Estriol 16,17-Diacetate 805-26-5 25mg H O
O
0025 H H
HO
O
MM0130.15-
Estriol Triacetate 2284-32-4 25mg O
H O
O
0025 H H
O
OH
MM0130.16- H OH
Estriol 3-Benzyl Ether 18650-87-8 25mg H H
0025 O
OH
H O
MM0130.17 16-Oxoestradiol 566-75-6 100mg H H
HO
OH
MM0130.17- H O
16-Oxoestradiol 566-75-6 25mg H H
0025 HO
OH
H OH
OH
H OH
MM0130.18-
6-Oxoestriol 7323-86-6 25mg H H
0025 HO
O
Estrogens conjugated
O
Estrone
O
H
MM0282.00 Estrone 53-16-7 500mg
H H
HO
H
MM0282.01 Estrone 3-Methyl Ether 1624-62-0 100mg
H H
O
MM0282.01- H
Estrone 3-Methyl Ether 1624-62-0 25mg
0025 H H
O
H
MM0473.01 Estrone 3-Acetate 901-93-9 100mg O
H H
O
MM0473.01- H
Estrone 3-Acetate 901-93-9 25mg O
H H
0025
O
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-233
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
Estropipate
O
MM3774.00- H
Estropipate 7280-37-7 250mg O O
S
H H
HN
NH
0250 HO O
Eszopiclone
O
Cl
N O
O
N
O OH
O
(2R,3R)-2,3-Bis(benzoyloxy)butanedioic Acid O
MM0448.04 2743-38-6 100mg O
O
(Dibenzoyltartric Acid) HO O
O OH
O
MM0448.04- (2R,3R)-2,3-Bis(benzoyloxy)butanedioic Acid O
2743-38-6 25mg O
O
0025 (Dibenzoyltartric Acid) HO O
O
O
MM1207.05- O
Etacrynic Acid Ethyl Ester 23870-41-9 25mg Cl
0025 O Cl
O
O
MM1207.06- O
Etacrynic Acid Isopropyl Ester n/a 25mg Cl
0025 O Cl
O
O
MM1207.07- Methyl 2-[2,3-Dichloro-4-[2-(methoxymethyl)butanoyl] O
n/a 25mg Cl
0025 phenoxy]acetate O O Cl
Etafedrine Hydrochloride
OH
N
MM0718.00 Etafedrine Hydrochloride 530-35-8 100mg HCl
OH
H
MM0718.01- N
HCl
2-(Ethylamino)-1-phenylpropan-1-ol Hydrochloride 63401-08-1 25mg
0025
Etamivan
O
O
MM1682.00 Etamivan 304-84-7 100mg N
HO
Etamsylate
HO
MM0632.01-
Impurity A (EP): Benzene-1,4-diol (Hydroquinone) 123-31-9 250mg
0250 OH
OH
OH
H 2N N
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-234
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
Ethambutol Hydrochloride
HO
H
Ethaverine Hydrochloride
O
N
Ethenzamide
O
MM0123.00- H
Ethinylestradiol 57-63-6 250mg H H
0250 HO
(10),9(11)-tetraen-20-yne-3,17-diol monohydrate
O
OH
OH
estradiol) HO
OH
OH
OH
estradiol) HO
OH
pregna-1,3,5(10)-trien-20-yn-6-one (6-Oxo- H
38002-18-5 25mg
0025 ethinylestradiol, 6-Ketoethinylestradiol) HO
H H
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-235
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
OH
Impurity I (EP): 19-Nor-17 -pregna-1,3,5(10),6-
H
MM0123.08 tetraen-20-yne-3,17-diol (6,7-Didehydroethinyl- 67703-68-8 50mg H H
estradiol) HO
OH
OH
H
MM0123.15 Estradiol 3-Methyl Ether 1035-77-4 100mg
H H
O
OH
MM0123.15- H
Estradiol 3-Methyl Ether 1035-77-4 25mg
0025 H H
O
OH
H
MM1698.00 Mestranol (Ethinylestradiol 3-Methyl Ether) 72-33-3 250mg H H
O
Ethionamide
S
O
S
MM0845.01-
Ethionamide Sulphoxide 536-28-7 25mg NH2
0025 N
N
MM0845.03-
Impurity B (EP): Pyridine-4-carbonitrile 100-48-1 25mg
0025 N
Ethisterone
OH
H
MM0967.00 Ethisterone 434-03-7 250mg
H H
O
Ethosuximide
H
N
O O
MM0750.00 Ethosuximide 77-67-8 500mg
OH O
Impurity A (EP): (2RS)-2-Ethyl-2-methylbutanedioic Acid O OH
MM0750.01
Related compound A (USP)
631-31-2 100mg
OH O
MM0750.01- Impurity A (EP): (2RS)-2-Ethyl-2-methylbutanedioic Acid O OH
Related compound A (USP)
631-31-2 25mg
0025
Ethyl Biscoumacetate
O O O O
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-236
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
Ethyl Maltol
HO
MM3722.00 Ethyl Maltol 4940-11-8 250mg O
Ethyl Nicotinate
O
Ethyl Parahydroxybenzoate
O
MM0498.00- O
Ethyl Parahydroxybenzoate 120-47-8 250mg
0250 HO
O
MM0498.05 Sodium Ethyl Parahydroxybenzoate 35285-68-8 500mg
+ O
Na
O
MM0045.01-
Impurity A (EP): 4-Hydroxybenzoic Acid 99-96-7 250mg OH
0250
HO
O
MM0431.00- Impurity B (EP): Methyl 4-Hydroxybenzoate (Methyl O
99-76-3 250mg
0250 Parahydroxybenzoate)
HO
O
MM0432.00- Impurity C (EP): Propyl 4-Hydroxybenzoate O
94-13-3 250mg
0250 (Propyl Parahydroxybenzoate) HO
O
Impurity D (EP): Butyl 4-Hydroxybenzoate O
MM0496.00 94-26-8 500mg
(Butyl Parahydroxybenzoate) HO
Ethylmorphine Hydrochloride
N
O O OH
Hydrochloride Trihydrate HO O OH
O O OH
OH
H2O
MM0442.00 41444-62-6 CS 100mg O
Phosphate Hemihydrate O O OH
2
2
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-237
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
Ethynodiol Diacetate
O
Etidronate Disodium
O
O OH
P
MM3079.00 Etidronate Disodium 7414-83-7 250mg HO P
OH Na
+
2
O
O
Etilefrine Hydrochloride
OH
H
MM0035.00- HO N
Etilefrine Hydrochloride 943-17-9 250mg HCl
0250
O
MM0035.05- Impurity E (EP): 1-(3-Hydroxyphenyl)ethanone HO
121-71-1 25mg
0025 (3-Hydroxyacetophenone)
OH
MM0035.09- HCl
2-Ethyl-1,2,3,4-tetrahydro-4,8-isoquinolinediol Hydrochloride n/a 25mg N
0025 OH
OH
MM0035.10- HO
HCl
2-Ethyl-1,2,3,4-tetrahydro-4,6-isoquinolinediol Hydrochloride n/a 25mg N
0025
O
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-238
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
O
MM0035.50-
3-Benzoyloxyacetophenone 139-28-6 25mg O
0025 O
Etizolam
N
N
N
S
MM1386.00-
Etizolam 40054-69-1 CS 250mg N
0250
Cl
Etodolac
H
N
MM0911.00 Etodolac 41340-25-4 250mg O
O
HO
Etodolac)
(8-Methyl Etodolac)
O
O
Impurity G (EP): 2-[(1RS)-8-Ethyl-1-propyl-1,3,4,9-
H
MM0911.07 tetrahydropyrano[3,4-b]indol-1-yl]acetic Acid 57816-83-8 100mg N
O
OH
(1-Propyl Etodolac)
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-239
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
O
Impurity G (EP): 2-[(1RS)-8-Ethyl-1-propyl-1,3,4,9-
MM0911.07- H
tetrahydropyrano[3,4-b]indol-1-yl]acetic Acid 57816-83-8 25mg N
O
OH
H
N
MM0911.08- OH
Impurity H (EP): 2-(7-Ethylindol-3-yl)ethanol 41340-36-7 25mg
0025
Etodolac)
O
Impurity K (EP): Methyl 2-[(1RS)-1,8-Diethyl-1,3,4,9- H
N O
MM0911.11 tetrahydropyrano[3,4-b]indol-1-yl]acetate 122188-02-7 100mg O
H
N O
O
MM0911.13 Etodolac Ethyl Ester 200880-23-5 100mg
H
MM0911.13- N O
O
Etodolac Ethyl Ester 200880-23-5 25mg
0025
O
H
MM0911.14- N O
O
Etodolac Isopropyl Ester n/a 25mg
0025
Etofenamate
O
O
O OH
NH
MM0105.00 Etofenamate 30544-47-9 250mg
F
F
F
OH
F F
NH
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-240
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
O O
O
O O
O
O
O O
O
MM0105.06 Impurity F (EP): 2,2'-Oxydiethanol 111-46-6 100mg HO OH
O
OH
O
O
OH
O
O O
O
O O
NH
F F
O O
O
O O
NH
F F
O O
O
O O
NH
F F
O O
O
O O
NH
MM0105.10-
Etofenamate Stearate 81427-97-6 25mg F
0025 F F
O
O OH
O O
F F
Etofylline
O
N OH
MM0603.00- N
Etofylline 519-37-9 250mg
0250 O N N
Etomidate
N
O
N
MM1264.00 Etomidate 33125-97-2 100mg O
OH
Impurity A (EP) as R-Enantiomer: 1-[(1R)-1-Phenylethyl]-1H- N
MM1264.04 56649-48-0 50mg
imidazole-5-carboxylic Acid (Etomidate Acid) O
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-241
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
Etoposide
O
O
O O
H O
HO
OH
H
H
O
O
OH
O
O
Glucopyranoside))
OH
O O
Etoposide Phosphate
O
O
H O O
O
MM3886.00-
Etoposide Phosphate (Etopophos) 117091-64-2 250mg O
HO
H
OH
H
O
O
O P OH
0250 O
O
O
OH
O
O
HO O
O
MM3886.01- HO H
O
Lignan P Phosphate n/a 25mg HO
OH
H
O
O P OH
0025 O
O
OH
O
Etoricoxib
O O
S
Cl
MM0965.00 Etoricoxib 202409-33-4 250mg
N
O O
S
4-Methylsulfonylacetophenone
MM0965.01 10297-73-1 100mg
Related compound A (USP): 4-methylsulfonyl acetophenone
O
O O
S
MM0965.01- 4-Methylsulfonylacetophenone
10297-73-1 25mg
0025 Related compound A (USP): 4-methylsulfonyl acetophenone
O
4-(Methylsulfonyl)phenylacetic Acid O O
S
O
MM0965.02 Related compound B (USP): 4-(methylsulfonyl)-phenyl acetic 90536-66-6 100mg
OH
acid
4-(Methylsulfonyl)phenylacetic Acid O O
MM0965.02- S
O
Related compound B (USP): 4-(methylsulfonyl)-phenyl acetic 90536-66-6 25mg
0025 OH
acid
Cl
2-Chloro-1,3-bis(dimethylamino)trimethinium +
N N
Hexafluorophosphate
MM0965.03 249561-98-6 100mg F F
Related compound C (USP): 2-chloro-1,3-bis
F P F
(dimethylamino)trimethinium hexafluorophosphate F F
Cl
2-Chloro-1,3-bis(dimethylamino)trimethinium +
N N
MM0965.03- Hexafluorophosphate
249561-98-6 25mg F F
0025 Related compound C (USP): 2-chloro-1,3-bis
F P F
(dimethylamino)trimethinium hexafluorophosphate F F
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-242
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
O O
S
MM0965.04- 5-Chloro-3-(4-methylsulfonylphenyl)-2-(pyridin-3-yl)pyridine Cl
202409-31-2 25mg
0025 (6 -Desmethyletoricoxib) N
O O
S
O O
S
MM0965.05-
1-(6-Methyl-3-pyridinyl)-2-[4-(methylsulfonyl)phenyl]ethanone 221615-75-4 25mg
0025
O
S
MM0965.07- N
2-[4-(Methylsulfanyl)phenyl]acetonitrile 38746-92-8 25mg
0025
Etosalamide
O
Etretinate
O
Eucalyptus Oil
O
MM1763.00 1,8-Cineole (Eucalyptol) 470-82-6 250mg
Eugenol
OH
Exemestane
O
H
MM1161.00 Exemestane 107868-30-4 250mg H H
O
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-243
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
H
MM1161.02- Impurity B (EP) as 6 -Isomer: 6 -Hydroxymethylandrosta-
121021-51-0 25mg H H
0025 1,4-diene-3,17-dione O
OH
O
Impurity D (EP): Androsta-1,4-diene-3,17-dione
H
MM0323.07 (Androstadienedione) 897-06-3 100mg
H H
Related compound C (USP): androsta-1,4-diene-3,17-dione O
O
Impurity D (EP): Androsta-1,4-diene-3,17-dione
MM0323.07- H
(Androstadienedione) 897-06-3 25mg
0025 H H
Related compound C (USP): androsta-1,4-diene-3,17-dione O
Ezetimibe
F
MM0935.00- F O
N
Ezetimibe 163222-33-1 250mg
0250 OH
OH
F
(3R,4S)-1-(4-Fluorophenyl)-3-[(3R)-3-(4-fluorophenyl)-3-
F O
N
MM0935.02 hydroxypropyl]-4-(4-hydroxyphenyl)-2-azetidinone ((3'R)- 163380-16-3 100mg
OH
OH
Ezetimibe)
F
(3R,4S)-1-(4-Fluorophenyl)-3-[(3R)-3-(4-fluorophenyl)-3-
MM0935.02- F O
N
F O
N
F O
N
MM0935.03-
Ezetimibe Ketone Benzyl Ether 190595-65-4 25mg O
O
0025
O
HN O
MM0935.08-
(S)-(+)-4-Phenyloxazolidin-2-one 99395-88-7 25mg
0025
F
MM0935.10- O
4-Fluoronitrobenzene 350-46-9 50mg +
0050 N
O
F
F O
N
MM0935.11-
4'-O-Benzyloxy Ezetimibe 163222-32-0 25mg OH
O
0025
F
MM0935.12-
4-[[(4-Fluorophenyl)imino]methyl]phenol 3382-63-6 25mg N
0025 HO
N-Nitrosoezetimibe ((4S)-3-[(2R,5S)-2-[(S)-(4-Fluoro-N- F
O
N O
O
MM0935.13- N
O
N
nitrosoanilino)-(4-hydroxyphenyl)methyl]-5-(4-fluorophenyl)-5- n/a 25mg
0025 OH
F
hydroxy-pentanoyl]-4-phenyl-oxazolidin-2-one)
OH
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-244
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
Famciclovir
O
N
N
O
Cl
O
N
9-[4-Acetoxy-3-(acetoxymethyl)butyl]-2-amino- N
N
O
H 2N N
6-chloropurine
MM0620.01 97845-60-8 100mg O
Cl
O
N
MM0620.01- 9-[4-Acetoxy-3-(acetoxymethyl)butyl]-2-amino- N
N
O
H 2N N
6-chloropurine
97845-60-8 25mg O
0025
O
2-[2-(2-Amino-9H-purin-9-yl)ethyl]propane-1,3-diol
N
N
Hydrochloride N
OH
HCl
MM0620.02 246021-75-0 100mg H 2N N
OH
Related compound A (USP): 2-[2-(2-Amino-9H-purin-9-yl)
ethyl]propane-1,3-diol
2-[2-(2-Amino-9H-purin-9-yl)ethyl]propane-1,3-diol
N
N
MM0620.02- Hydrochloride N
OH
HCl
246021-75-0 25mg H 2N N
OH
0025 Related compound A (USP): 2-[2-(2-Amino-9H-purin-9-yl)
ethyl]propane-1,3-diol
N
MM0620.19- N
2-Aminopurine
452-06-2 25mg N
0025 Related compound E (USP): 2-aminopurine H 2N N
H
Cl
MM0620.20- 2-Amino-6-chloropurine N
N
10310-21-1 25mg
0025 Related compound F (USP): 2-Amino-6-chloropurine N
H 2N N
H
Famotidine
N H2 N H 2O O
S
S N
S
NH2
N
N
S
NH
NH2 HCl
MM0029.06 76833-47-1 100mg
methyl]sulfanyl]propanimidamide S
Hydrochloride
Impurity A (EP) as Hydrochloride: 3-[[[2-
MM0029.06- [(Diaminomethylene)amino]thiazol-4-yl]- H 2N
NH2
N
N
S
NH
NH2 HCl
76833-47-1 25mg
0025 methyl]sulfanyl]propanimidamide S
Hydrochloride
Impurity B (EP): 3,5-Bis[2-[[[2-[(diaminomethylidene)amino]
thiazol-4-yl]methyl]sulfanyl]ethyl]-4H-1,2,4,6-thiatriazine 1,1-
MM0029.13- Dioxide H2 N
NH2
N
S
O
N
S
N
O
S
N
H2 N
NH2
0025
[(diaminomethylene)amino]thiazol-4-yl]methyl]sulphany]
ethyl]-4H-1,2,4,6-thiatriazine1,1-dioxide
Impurity B (EP) as Dimaleate: 3,5-
Bis[2-[[[2-[(diaminomethylene)-
amino]-thiazol-4-yl]methyl]-
MM0029.05- sulfanyl]ethyl]-4H-1,2,4,6- H 2N
N H2
N
N
S
O
N
S
N
H
O
S
N
H 2N
N
NH2
O
OH
OH
0025
Related compound B (USP): 3,5-bis[2-[[[2-
[(diaminomethylene)amino]thiazol-4-yl]methyl]sulphany]
ethyl]-4H-1,2,4,6-thiatriazine1,1-dioxide
Impurity C (EP) as Hydrochloride: 3-[[[2-
[(Diaminomethylene)amino]thiazol-4-
yl]methyl]sulfanyl]-N-sulfamoyl- N H2 O O O
S
S N
H
S
N H 2 HCl
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-245
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
S
S N
H
S
N H 2 HCl
S
S NH2
S
S NH2
N
N
S S
N
H2 N
N
N H2
(methylene)bis(thiazole-4,2-diyl)]diguanidine
Impurity E (EP): 2,2'-[Disulfanediylbis-
MM0029.07- (methylenethiazole-4,2-diyl)]diguanidine H 2N
NH2
N
N
S S
N
H2 N
N
N H2
0025
(methylene)bis(thiazole-4,2-diyl)]diguanidine
Impurity F (EP): 3-[[[2-[(Diaminomethylene)-
amino]thiazol-4-yl]methyl]sulfanyl]- NH2 O
S
S OH
S
S OH
[(diaminomethylene)amino]thiazol-4-yl]methyl]sulfanyl]
OH
H2 N N
S N
N H OH
MM0029.09 n/a 100mg S
O
propanimidamide Maleate
[(diaminomethylene)amino]thiazol-4-yl]methyl]sulfanyl]
OH
H2 N N
S N
N H OH
n/a 25mg S
O
0025 propanimidamide Maleate
S
S NH2
HCl
2
N
O
S
O
N H2
1020719-36-1 25mg N H
0025 methyl]sulfinyl]-N-sulfamoylpropanamide S
O
N H2 N H 2O O
S
S
O
N
S
NH2
N H2 N H 2O O
MM0029.04-
Famotidine Sulfoxide 90237-03-9 25mg H 2N
N
N
S
S
O
N
S
NH2
0025
ethylsulfanylmethyl]-1,3-thiazol-2-yl]guanidine Maleate)
Famotidine Acetaldehyde Adduct Maleate (2-[4-[2-(3-Methyl- O
MM0029.16- H 2N
N H2
N
HN NH
S O
OH
S N OH
1,1-dioxo-3,4-dihydro-2H-1,2,4,6-thiatriazin-5-yl) n/a 25mg N
S
O
O
0025
ethylsulfanylmethyl]-1,3-thiazol-2-yl]guanidine Maleate)
Famotidine Formaldehyde Adduct Maleate (2-[4-[2-(1,1- O
NH2 HN NH
OH
H2 N N S O
S N OH
MM0029.17 Dioxo-3,4-dihydro-2H-1,2,4,6-thiatriazin-5-yl) n/a 100mg N O
S
O
ethylsulfanylmethyl]-1,3-thiazol-2-yl]guanidine Maleate)
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-246
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
MM0029.17- NH2 HN NH
OH
H2 N N S O
S N OH
Dioxo-3,4-dihydro-2H-1,2,4,6-thiatriazin-5-yl) n/a 25mg N O
S
O
0025
ethylsulfanylmethyl]-1,3-thiazol-2-yl]guanidine Maleate)
Famprofazone
O
MM0994.02- 5-[[Hydroxy(methyl)amino]methyl]-4-isopropyl-1-methyl-2- N
88913-10-4 25mg N
0025 phenylpyrazol-3-one
N
HO
Favipiravir
O
F N
MM3892.00- N H2
Favipiravir 259793-96-9 250mg
0250 N O
H
O
MM3892.05- F N
3,6-Difluoropyrazine-2-carboxamide 356783-29-4 25mg NH2
0025
N F
N
F N
MM3892.06-
3,6-Difluoropyrazine-2-carbonitrile 356783-28-3 25mg
0025
N F
Febantel
H
N S
O
O
O N NH
H
O O
O
H
MM0518.00- Impurity C (EP): Methyl [5-(Phenylsulfanyl)-1H-benzimidazol- N O
43210-67-9 250mg N
H
S N
0250 2-yl]carbamate (Fenbendazole)
Febuxostat
N
O
O
S
N
OH
MM3552.01- 2-(3-Cyano-4-hydroxyphenyl)-4-methyl-5-thiazolecarboxylic HO
S
407582-48-3 25mg
0025 Acid (Desisobutylfebuxostat) O
N
N
MM3552.02- Febuxostat Ethyl Ester (2-[3-Cyano-4-(2-methylpropoxy) O
O
S
160844-75-7 25mg O
0025 phenyl]-4-methyl-5-thiazolecarboxylic Acid Ethyl Ester) N
Felbinac
OH
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-247
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
MM3501.01-
Impurity A (EP): 4-Acetyl Biphenyl 92-91-1 25mg
0025
O
MM3501.02 Felbinac Methyl Ester 59793-29-2 100mg
O
MM3501.03 Felbinac Ethyl Ester 14062-23-8 100mg
O
MM3501.04 Felbinac Isopropyl Ester 1286423-88-8 100mg
O
O OH
OH
O
MM3501.06-
Felbinac 2,3-Butylene Glycol Ester n/a 25mg O
0025
OH
O
MM3501.07-
Felbinac 1,2-Propylene Glycol Esters (Mixture of Isomers) n/a 25mg O
0025 OH
O
O O
MM3501.09- 3-[2-(4-Phenylphenyl)acetyl]oxybutyl 2-(4-Phenylphenyl) O O
n/a 25mg
0025 acetate
O
Felodipine
H
N
O O
MM0139.00-
Felodipine 72509-76-3 250mg O O
0250 Cl
Cl
Dichlorophenyl)-2,6-dimethylpyridine-3,5- O O
Cl
H
N
Cl
H
N
Impurity C (EP): Diethyl 4-(2,3- O O
H
N
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-248
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
Cl
MM0139.05 2,3-Dichlorobenzaldehyde 6334-18-5 100mg
Cl
MM0139.05- Cl
2,3-Dichlorobenzaldehyde 6334-18-5 25mg
0025
Cl
Fenbendazole
O
H
MM0518.00- N O
Fenbendazole 43210-67-9 250mg N
H
S N
0250
Impurity A (EP): Methyl (1H-Benzimidazol-2- O
H
yl)carbamate (Carbendazim) N O
N
Related compound A (USP): Methyl (1H-benzimidazole-2-
MM2500.00 10605-21-7 100mg
H
N
yl)carbamate
Impurity B (EP): Methyl (5-Chloro-1H-benzimidazol- O
2-yl)carbamate H
N O
N
Related compound B (USP): Methyl [5(6)-
MM0518.04 20367-38-8 100mg H
Cl N
chlorobenzimidazole-2-yl]carbamate
Impurity B (EP): Methyl (5-Chloro-1H-benzimidazol- O
MM0518.04- 2-yl)carbamate H
N O
N
Related compound B (USP): Methyl [5(6)-
20367-38-8 25mg H
0025 Cl N
chlorobenzimidazole-2-yl]carbamate
O
H
N O
O
H
N O
O O
O
H
N O
MM0518.02-
Fenbendazole Sulphone 54029-20-8 25mg S N
N
H
0025 O O
Fenbufen
O
OH
O
4-(4-Chlorophenyl)-4-oxobutanoic Acid OH
MM0918.05
(3-(4-Chlorobenzoyl)propionic Acid)
3984-34-7 100mg O
Cl
O
MM0918.05- 4-(4-Chlorophenyl)-4-oxobutanoic Acid OH
3984-34-7 25mg
0025 (3-(4-Chlorobenzoyl)propionic Acid) Cl
O
O
O
MM0918.06-
Fenbufen Methyl Ester 54011-27-7 25mg O
0025
O
O
MM0918.07-
Fenbufen Ethyl Ester 1230-54-2 25mg O
0025
O
O
MM0918.08-
Fenbufen Isopropyl Ester n/a 25mg O
0025
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-249
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
Fencamfamine Hydrochloride
Camfetamine Hydrochloride
HCl
MM0995.01 (N-Methyl-3-phenylnorbornan-2-amine 39628-11-0 100mg
Hydrochloride) HN
Camfetamine Hydrochloride
MM0995.01- HCl
(N-Methyl-3-phenylnorbornan-2-amine 39628-11-0 25mg
0025 Hydrochloride) HN
Fenclofenac
OH
O
O
Cl
O
O
Cl
O
O
MM3075.02 Cl
Fenclofenac Ethyl Ester 86308-84-1 100mg
Cl
O
O
MM3075.03 Cl
Fenclofenac Isopropyl Ester n/a 100mg
Cl
Fenfluramine Hydrochloride
H
N
N H2
N H2
MM0608.01-
Norfenfluramine Hydrochloride 673-18-7 25mg HCl
0025 F
F
F
O
N
N
Fenofibrate
O
Cl O
O
MM0505.00 Fenofibrate 49562-28-9 500mg
O
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-250
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
hydroxyphenyl)methanone
Impurity B (EP): 2-[4-(4-Chlorobenzoyl)phenoxy]- O
phenoxy)-2-methylpropanoic acid
O
217636-47-0 25mg
0025 phenoxy]butan-2-one O
Cl O
Impurity F (EP): (4-Chlorophenyl)[4-(1-methyl-
MM0505.06 154356-96-4 100mg
ethoxy)phenyl]methanone O
Cl O
MM0505.06- Impurity F (EP): (4-Chlorophenyl)[4-(1-methyl-
154356-96-4 25mg
0025 ethoxy)phenyl]methanone O
MM0505.07- methylpropanoate Cl O
O
O
O
Fenoldopam Mesilate
Cl
HO
NH
HO O O
HO
N-Methyl-6-Chloro-2,3,4,5-tetrahydro-1-(4-hydroxyphenyl)- Cl
HO
1H-3-benzazepine-7,8-diol Hydrochloride (N- N
MM3411.01- HO
HCl
Methylfenoldopam Hydrochloride) n/a 25mg
0025
Related compound A (USP): N-Methyl-6-chloro-2,3,4,5-
HO
tetrahydro-1-(4-hydroxyphenyl)-1H-3-benzazepine-7,8-diol
Fenoprofen Calcium
O O H2O
O O
MM0790.02 Fenoprofen Methyl Ester 66202-87-7 100mg O
O O
MM0790.03 Fenoprofen Ethyl Ester 32929-74-1 100mg O
O O
MM0790.04 Fenoprofen Isopropyl Ester 120824-55-7 100mg O
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-251
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
O O
O OH
MM0790.05- Fenoprofen 1,3-Butylene Glycol Esters (Mixture of Regio-
n/a 25mg
0025 and Stereoisomers) O O OH
OH
MM0790.06- O O
Fenoprofen 2,3-Butylene Glycol Ester 2731414-11-0 25mg O
0025
OH
O O
O
MM0790.07- Fenoprofen 1,2-Propylene Glycol Esters (Mixture of Regio-
n/a 25mg
0025 and Stereoisomers) O O
OH
O
OH
O O OH
O
MM0790.08- Fenoprofen 1,2,3-Propanetriol Esters (Mixture of Regio- and
n/a 25mg
0025 Stereoisomers) O O
OH
O
OH
Fenspiride Hydrochloride
O
HCl
O
MM3773.00- NH
Fenspiride Hydrochloride 5053-08-7 250mg N
0250
Fentanyl
O N
N-Oxide Hydrochloride)
O NH
O NH
MM0528.05- O
Impurity E (EP): Benzaldehyde 100-52-7 500mg
0500
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-252
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
H2 N
Impurity F (EP) as Hydrochloride: Aniline Hydrochloride HCl
MM0093.17 142-04-1 100mg
(Phenylamine Hydrochloride)
NH
MM0528.07 Impurity G (EP): N-Phenylpropanamide 620-71-3 100mg
NH
MM0528.07-
Impurity G (EP): N-Phenylpropanamide 620-71-3 25mg
0025
N
Impurity J (EP): 1-Benzyl-N-phenylpiperidin-4-amine
MM0528.15- HN
Related compound D (USP): N-Phenyl-1-(phenylmethyl)-4- 1155-56-2 25mg
0025
piperidinamine
MM0528.19- O N HCl
1-(2-Phenylethyl)piperidin-4-yl Propanoate Hydrochloride n/a 25mg
0025 O
O N
MM0528.20-
Butyrfentanyl (Butyrylfentanyl) N
1169-70-6 CS 25mg
0025
O
MM0528.22-
1-(2-Phenylethyl)pyridin-2(1H)-one 18065-78-6 25mg N
0025
O
N O
MM0528.26- HN
tert-Butyl 4-(Phenylamino)piperidine-1-carboxylate 125541-22-2 25mg
0025
Fentanyl Citrate
O
OH
O N O
MM1383.00-
Fentanyl Citrate 990-73-8 CS 250mg N
OH
OH
OH
0250 O
O N
O
Imp A (EP) as Hydrochloride: (1rs,4rs)-1-(2-Phenylethyl)-4- O N
+
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-253
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
piperidinamine
MM0528.05- O
Impurity E (EP): Benzaldehyde 100-52-7 500mg
0500
N
Impurity G (EP): 1-Benzyl-N-phenylpiperidin-4-amine
MM0528.15- HN
Related compound D (USP): N-Phenyl-1-(phenylmethyl)-4- 1155-56-2 25mg
0025
piperidinamine
Fenticonazole Nitrate
Cl
Fenticonazole Nitrate
Cl
+
N
MM1216.00 73151-29-8 250mg O HO O
N
S
N
Cl
N
0025 S
O N
(Fenticonazole Sulfoxide Nitrate)
Cl
N
S
O O N
(Fenticonazole Sulfone Nitrate)
Cl
N
0025 S
O O N
(Fenticonazole Sulfone Nitrate)
Cl
MM1216.01 1-(Chloromethyl)-4-(phenylsulfanyl)benzene 1208-87-3 100mg S
Feprazone
O
N
MM0691.00 Feprazone 30748-29-9 50mg N
Ferulic Acid
O
O
OH
MM3388.00 Ferulic Acid (trans-4-Hydroxy-3-methoxycinnamic Acid) 537-98-4 100mg
HO
Fesoterodine Fumarate
O
N
OH
HO
O
OH
Fexofenadine Hydrochloride
OH HCl
OH
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-254
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
O
N
OH
(hydroxydiphenylmethyl)-1-piperidinyl]butyl]-alpha,alpha-
dimethyl benzeneacetic acid
Impurity A (EP): 2-[4-[4-[4-(Hydroxydiphenyl-
methyl)piperidin-1-yl]butanoyl]phenyl]-2-
MM0507.01- methylpropanoic Acid (Ketofexofenadine) OH
O
N
0025 OH
(hydroxydiphenylmethyl)-1-piperidinyl]butyl]-alpha,alpha-
dimethyl benzeneacetic acid
Impurity B (EP) as Hydrochloride Monohydrate: 2-[3-[(1RS)-
1-Hydroxy-4-[4-(hydroxydiphenylmethyl)piperidin-1-yl]butyl] O
(hydroxydiphenylmethyl)-1-piperidinyl]butyl]-alpha,alpha-dimethyl
benzeneacetic acid
Impurity C (EP): (1RS)-4-[4-(Hydroxydiphenyl-
OH
methyl)piperidin-1-yl]-1-[4-(1-methylethyl)- OH
N
phenyl]butan-1-ol
MM0507.03 185066-37-9 100mg
Related compound C (USP)
Impurity C (EP): (1RS)-4-[4-(Hydroxydiphenyl-
OH
MM0507.03- methyl)piperidin-1-yl]-1-[4-(1-methylethyl)- OH
N
phenyl]butan-1-ol
185066-37-9 25mg
0025
Related compound C (USP)
NH
NH
MM0055.02-
Impurity E (EP): Diphenyl(piperidin-4-yl)methanol 115-46-8 25mg OH
0025
n/a 25mg N
(hydroxydiphenylmethyl)piperidin-1-yl]-butyl]phenyl]-2-
OH
(hydroxydiphenylmethyl)piperidin-1-yl]-butyl]phenyl]-2-
OH
154825-96-4 25mg N
O
OH
MM0507.19- +
OH
HCl
n/a 25mg N
Fexofenadine N-Oxide Hydrochloride O
O
0025 OH
Finasteride
O H
N
MM0415.00-
Finasteride 98319-26-7 250mg H
H H
0250 O N
H H
O H
H
MM0415.01 4-aza-5 -androstane-17 -carboxamide 98319-24-5 100mg H H
(Dihydrofinasteride) O N
H H
O H
MM0415.01- H
4-aza-5 -androstane-17 -carboxamide 98319-24-5 25mg H H
(Dihydrofinasteride)
0025 O N
H H
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-255
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
O
O
O
O
O
OH
O
OH
H
MM0415.05 Finasteride Acid 104239-97-6 100mg
H H
O N
H H
O
OH
MM0415.05- H
Finasteride Acid 104239-97-6 25mg
0025 H H
O N
H H
O H
N
O H
N
MM0415.08- H
3-Oxo-N-phenyl-4-aza-5 -androst-1-ene-17 -carboxamide 158522-79-3 25mg H H
0025 O N
H H
O H
N
MM0415.12- H
N-(1,1-Dimethylethyl)-3-oxoandrost-4-ene-17 -carboxamide 131267-80-6 25mg
0025 H H
O
Fingolimod Hydrochloride
HO OH
NH2 HCl
heptylphenyl)ethyl]propane-1,3-diol Hydrochloride 162361-44-6 25mg
0025
(Fingolimod Heptyl Analogue)
MM3554.01- O O
O
Diethyl 2-Acetamido-2-[2-(4-octylphenyl)ethyl]propanedioate 162358-08-9 25mg O
NH
0025 O
O O
O O
MM3554.03 Diethyl Acetamidomalonate 1068-90-2 100mg HN
O O
MM3554.03- O O
Diethyl Acetamidomalonate 1068-90-2 25mg HN
0025
O
OH
MM3554.05- OH OH
3-Amino-3-(hydroxymethyl)-1-(4-octylphenyl)butane-1,4-diol
NH2
162361-49-1 25mg
0025 (1-Hydroxyfingolimod)
HO OH
MM3554.06- N
N,N-Dimethylfingolimod 1404433-87-9 25mg
0025
MM3554.07- I
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-256
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
Flavoxate Hydrochloride
O
N
O O
MM0156.05- 2-phenyl-4H-1-benzopyran-8-carboxylate
1286165-14-7 25mg
0025 (3-Methylflavone-8-carboxylic Acid Isopropyl O
Ester) O O
MM0156.07- HCl
Flavoxate N-Oxide Hydrochloride n/a 25mg O
+
N
0025 O O
O
Flecainide Acetate
F F O
O
F N O
H
F
OH
F F
trifluoroethoxy)phenyl]-1,5,6,7,8,8a-hexahydroimidazo[1,5-a] F
O N
phenyl]-1,5,6,7,8,8a-hexahydroimidazo-[1,5a]pyridine
Impurity A (EP) as Hydrochloride: (8aRS)-3-[2,5-Bis(2,2,2- F F N
MM0488.06- trifluoroethoxy)phenyl]-1,5,6,7,8,8a-hexahydroimidazo[1,5-a] F
O N
phenyl]-1,5,6,7,8,8a-hexahydroimidazo-[1,5a]pyridine
H2 N
MM0488.02 Impurity B (EP): (RS)-(Piperidin-2-yl)methanamine 22990-77-8 100mg HN
F F O
O
F OH
Impurity D (EP): 2,5-Bis(2,2,2-trifluoroethoxy)-
MM0488.04 35480-52-5 100mg O
benzoic Acid F
F F
F F O
O
F OH
MM0488.04- Impurity D (EP): 2,5-Bis(2,2,2-trifluoroethoxy)-
35480-52-5 25mg O
0025 benzoic Acid F
F F
O
HO
MM0217.10 2,5-Dihydroxybenzoic Acid 490-79-9 100mg OH
OH
O
MM0217.10- HO
2,5-Dihydroxybenzoic Acid 490-79-9 25mg OH
0025
OH
Fleroxacin
F
N F
O
F
O OH
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-257
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
Flibanserin Hydrochloride
O H
N
N
N
N
MM3222.00 Flibanserin 167933-07-5 250mg
F
F
F
Fluanisone
O
MM1247.02-
1-(2-Methoxyphenyl)piperazine Dihydrochloride 38869-49-7 25mg N
HCl
2
0025 HN O
Flubendazole
O
H
F N O
benzimidazol-2-yl]carbamate O
0025 benzimidazol-2-yl]carbamate O
H
F
Impurity B (EP): (2-Amino-1H-benzimidazol- N
NH2
MM0463.02 82050-13-3 100mg N
5-yl)(4-fluorophenyl)methanone O
H
F
MM0463.02- Impurity B (EP): (2-Amino-1H-benzimidazol- N
NH2
82050-13-3 25mg N
0025 5-yl)(4-fluorophenyl)methanone O
H
F
Impurity B (EP) as Hydrochloride: (2-Amino-1H- N
NH2
MM0463.09 n/a 100mg N
benzimidazol-5-yl)(4-fluorophenyl)methanone Hydrochloride O HCl
H
F
MM0463.09- Impurity B (EP) as Hydrochloride: (2-Amino-1H- N
NH2
n/a 25mg N
0025 benzimidazol-5-yl)(4-fluorophenyl)methanone Hydrochloride O HCl
H
F
MM0463.03- Impurity C (EP): (4-Fluorophenyl)(2-hydroxy- N
OH
1097107-40-8 25mg N
0025 1H-benzimidazol-5-yl)methanone O
H
F N
Impurity D (EP): (1H-Benzimidazol-5-yl)(4-
MM0463.04 n/a 100mg N
fluorophenyl)methanone O
H
F N
MM0463.04- Impurity D (EP): (1H-Benzimidazol-5-yl)(4-
n/a 25mg N
0025 fluorophenyl)methanone O
O
H
MM0463.05- Impurity E (EP): Methyl [5-(2-Fluorobenzoyl)- N
N
O
66939-00-2 25mg H
0025 1H-benzimidazol-2-yl]carbamate F O
N
132119-20-1 25mg N
0025 1-methyl-1H-benzimidazol-2-yl]carbamate O
benzoyl]-1H-benzimidazol-2-yl]carbamate O
O
MM0463.07- Impurity G (EP): Methyl [5-[4-(1-Methylethoxy)- O
H
N
N
H
O
n/a 25mg N
0025 benzoyl]-1H-benzimidazol-2-yl]carbamate O
Flucloxacillin Sodium
Cl O +
O Na
O
S
H2 O
H
O
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-258
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
5-methylisoxazol-4-yl]carbonyl]amino]methyl]- N F
H
HN
MM0489.01 68728-50-7 100mg
5,5-dimethylthiazolidine-4-carboxylic Acid O
O
N S
MM0489.01- 5-methylisoxazol-4-yl]carbonyl]amino]methyl]- N F
H
HN
68728-50-7 25mg
0025 5,5-dimethylthiazolidine-4-carboxylic Acid O
O
N S
S
thiazolidine-4-carboxylic Acid O
O
Impurity C (EP): (2S,5R,6R)-6-Amino-3,3- OH
O
MM0026.04- dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]- N
551-16-6 25mg
0025 heptane-2-carboxylic Acid
H 2N S
(6-Aminopenicillanic Acid) H
Cl
Cl
Fluconazole
F
F
N
MM0235.00- HO
Fluconazole 86386-73-4 250mg N
N
0250
N
N
N
F
Impurity A (EP): (2RS)-2-(2,4-Difluorophenyl)- N
HO
MM0235.11 1-(1H-1,2,4-triazol-1-yl)-3-(4H-1,2,4-triazol- 89429-59-4 100mg N
N
4-yl)propan-2-ol N
N N
F
MM0235.11- Impurity A (EP): (2RS)-2-(2,4-Difluorophenyl)- N
HO
1-(1H-1,2,4-triazol-1-yl)-3-(4H-1,2,4-triazol- 89429-59-4 25mg N
N
0025 4-yl)propan-2-ol N
N N
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-259
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
N N
Impurity B (EP): 2-[2-Fluoro-4-(1H-1,2,4-triazol-1- N
MM0235.12- yl)phenyl]-1,3-bis(1H-1,2,4-triazol-1-yl)propan- F
N
2-ol 871550-15-1 25mg HO
N
0025 Related compound A (USP): 2-[2-fluoro-4-(1H-1,2,4-triazol- N
N
1-yl)phenyl]-1,3-bis(1H-1,2,4-triazol-1-yl)-propan-2-ol N
N
F
MM1094.04- Impurity E (EP): 1-(2,4-Difluorophenyl)-2-(1H-1,2,4-triazol-1- N
86404-63-9 25mg N
0025 yl)ethanone F O N
F
MM0235.02- Impurity F (EP): (2RS)-2-(2,4-Difluorophenyl)-3- N
HO
118689-07-9 25mg
0025 (1H-1,2,4-triazol-1-yl)propane-1,2-diol N
N
OH
F
Impurity H (EP): (2RS)-1-Bromo-2-(2,4-difluorophenyl)- N
HO
MM0235.07 150194-52-8 50mg
3-(1H-1,2,4-triazol-1-yl)propan-2-ol N
N
Br
F
MM0235.07- Impurity H (EP): (2RS)-1-Bromo-2-(2,4-difluorophenyl)- N
HO
150194-52-8 25mg
0025 3-(1H-1,2,4-triazol-1-yl)propan-2-ol N
N
Br
F
MM0235.01 2-(2,4-Difluorophenyl)propane-1,2,3-triol 173837-65-5 100mg HO
HO
OH
F
MM0235.01-
2-(2,4-Difluorophenyl)propane-1,2,3-triol 173837-65-5 25mg HO
0025 HO
OH
N
MM0235.03 1H-1,2,4-Triazole 288-88-0 100mg HN
N
N
MM0235.03-
1H-1,2,4-Triazole 288-88-0 25mg HN
0025 N
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-260
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
F
MM0235.04 2-Chloro-2',4'-difluoroacetophenone 51336-94-8 100mg
O
Cl
MM0235.04- F
2-Chloro-2',4'-difluoroacetophenone 51336-94-8 25mg
0025
O
Cl
F
1-(2,4-Difluorophenyl)-2-(1H-1,2,4-triazol-1-
MM0235.06 206050-23-9 100mg
yl)ethanol HO N
N
N
F
MM0235.06- 1-(2,4-Difluorophenyl)-2-(1H-1,2,4-triazol-1-
206050-23-9 25mg
0025 yl)ethanol HO N
N
N
N
N
MM0235.09 4-Amino-1,2,4-triazole 584-13-4 100mg N
H 2N
N
MM0235.09- N
4-Amino-1,2,4-triazole 584-13-4 25mg N
0025
H 2N
N
F
N N OH
MM0235.17- 2-(2-Dimethylamino-4-fluorophenyl)-1,3-bis(1H-1,2,4-triazol-
960243-81-6 25mg N
0025 1-yl)propan-2-ol N
N N
N N
N N
N
N
MM0235.18- 2-[2,4-Bis(1,2,4-triazol-1-yl)phenyl]-1,3-bis(1,2,4-triazol-1-yl) N
HO
871550-18-4 25mg
0025 propan-2-ol N
N
N
N
N
MM0235.19- 1-Amino-2-(2,4-difluorophenyl)-3-(1H-1,2,4-triazol-1-yl) HO
126916-76-5 25mg H 2N
0025 propan-2-ol
N
N
N
F F
2-(2,4-Difluorophenyl)-1-[[2-(2,4-difluorophenyl)-2-hydroxy-3- F F
MM0235.20- OH HO
H
(1,2,4-triazol-1-yl)propyl]amino]-3-(1,2,4-triazol-1-yl)propan-2- n/a 25mg N
0025 N N
ol N N
N N
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-261
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
Flucytosine
NH2
F
N
MM0355.00 Flucytosine 2022-85-7 250mg
O N
H
O
F
MM0593.00- Impurity A (EP): 5-Fluoropyrimidine- HN
51-21-8 250mg
0250 2,4(1H,3H)-dione (Fluorouracil)
O N
H
Fludarabine Phosphate
N H2
N
N
MM3428.00- F N N
Fludarabine Phosphate 75607-67-9 250mg OH
0250 O
HO O
P OH
HO
O
NH2
N H2
N
N
OH
HO
Fludeoxyglucose
4,7,13,16,21,24-Hexaoxa-1,10-diazabicyclo[8.8.8] O O
O O
MM3981.03- hexacosane
23978-09-8 25mg N N
0025 Related compound A (USP): 4,7,13,16,21,24-hexaoxa-1,10-
diazabicyclo[8.8.8]hexacosane O O
O O
MM3981.07- O O
Tri-O-acetyl-D-glucal 2873-29-2 25mg O O
0025
O
Fludrocortisone Acetate
O
O
O
HO OH
MM0817.00 Fludrocortisone Acetate 514-36-3 250mg H
F H
O
Flufenamic Acid
O
OH
NH
MM0410.00 Flufenamic Acid 530-78-9 500mg
F
F F
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-262
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
NH
MM0410.01 Flufenamic Acid Methyl Ester 2765-91-5 100mg
F
F F
NH
MM0410.02 Flufenamic Acid Ethyl Ester 2766-16-7 100mg
F
F F
NH
MM0410.03 Flufenamic Acid Isopropyl Ester 68749-59-7 100mg
F
F F
Fluindione
O
Flumazenil
N O
MM0762.00- N O
Flumazenil 78755-81-4 250mg
0250 F N
imidazo[1,5-a][1,4]benzodiazepine-3-carboxylic Acid N OH
MM0762.01 Related compound A (USP): 8-fluoro-5,6-dihydro-5-methyl- 84378-44-9 100mg
N
6-oxo-4H-imidazol-[1,5-alpha][1,4]benzodiazepine-3- F
O
carboxylic acid
Impurity A (EP): 8-Fluoro-5-methyl-6-oxo-5,6-dihydro-4H- N O
methyl-6-oxo-4H-imidazol-[1,5-alpha][1,4]benzodiazepine-3- O
carboxylate
H O
N
Impurity D (EP): 7-Fluoro-4-methyl-3,4-dihydro-1H-1,4-
MM0762.04 78755-80-3 100mg
benzodiazepine-2,5-dione F N
H O
N
MM0762.04- Impurity D (EP): 7-Fluoro-4-methyl-3,4-dihydro-1H-1,4-
78755-80-3 25mg
0025 benzodiazepine-2,5-dione F N
H 2N O
H
MM0762.09- 2-(7-Fluoro-4-methyl-5-oxo-2,3,4,5,-tetrahydro-1H-1,4- N O HCl
n/a 25mg F N
0025 benzodiazepine-2-ylidene )glycine Ethyl Ester Hydrochloride O
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-263
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
Flumequine
N
MM0842.00 Flumequine 42835-25-6 250mg OH
F
O O
Flumetasone Pivalate
O
H
MM0427.01 trihydroxy-16 -methylpregna-1,4-diene- 2135-17-3 100mg F H
3,20-dione (Flumetasone) O
F
Flunarizine Dihydrochloride
F
N
N
F
NH
N
Impurity A (EP): 1-[Bis(4-fluorophenyl)methyl]-
MM0175.04 27469-60-9 100mg
piperazine
F
F
NH
N
MM0175.04- Impurity A (EP): 1-[Bis(4-fluorophenyl)methyl]-
27469-60-9 25mg
0025 piperazine
F
Fluorophenyl)(4-fluorophenyl)methyl]-4-[(2E)- N
3-phenylprop-2-enyl]piperazine HCl
2
Dihydrochloride
Impurity C (EP) as Dihydrochloride: 1-[(RS)-(2- F
N
MM0175.03- Fluorophenyl)(4-fluorophenyl)methyl]-4-[(2E)- N
n/a 25mg F
Dihydrochloride
Cl
O
F +
N
N
Flunisolide Hemihydrate
OH
O
HO O
H
O
H2 O
O
F
2
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-264
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
Flunitrazepam
O
N
MM0069.00- O +
Flunitrazepam 1622-62-4 CS 250mg N N
0250 O
F
H O
N
H O
N
H O
N
N O
Impurity C (EP): 3-Amino-4-(2-
O +
MM0069.05 fluorophenyl)-1-methyl-6-nitroquinolin-2 n/a 100mg N
O
NH2
F
(1H)-one
N O
Impurity C (EP): 3-Amino-4-(2-
MM0069.05- O +
fluorophenyl)-1-methyl-6-nitroquinolin-2 n/a 25mg N
O
NH2
F
0025 (1H)-one
NH
Flunixin Meglumine
F F
F H
N
OH
OH
OH
OH HO
N Cl
N Cl
F F
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-265
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
F F
N Cl
Impurity C (EP): Ethyl 2-Chloropyridine-3-carboxylate O
Related compound C (USP): Ethyl 2-chloronicotinate
MM0915.03 1452-94-4 100mg
O
F F
F F
H
N
OH
F F
MM0915.05-
Flunixin Methyl Ester 75369-63-0 25mg N NH
0025
O
F F
MM0915.06-
Flunixin Isopropyl Ester n/a 25mg N NH
0025
O
Fluocinolone Acetonide
OH
O
HO O
MM1524.00-
Fluocinolone Acetonide 67-73-2 250mg H O
F H
0250 O
F
O
O
Impurity M (EP): 6 ,9-Difluoro-11 -hydroxy-16 ,17-(1-
MM3001.00- HO O
methylethylidenedioxy)-3,20-dioxopregna-1,4-dien-21-yl 356-12-7 250mg H O
0250 F H
Acetate (Fluocinonide) O
F
Fluocinonide
O
O
O
MM3001.00- HO O
Fluocinonide 356-12-7 250mg H O
0250 F H
O
F
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-266
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
Fluorescein
O
O
MM1533.01 Diacetylfluorescein 596-09-8 100mg O O
O O O
Fluorescein Sodium
HO OH
MM0294.01-
Impurity A (EP): Resorcinol 108-46-3 250mg
0250
OH
OH
Impurity C (EP): 2-(2,4-Dihydroxybenzoyl)benzoic O
Acid
Related compound C (USP): 2-(2,4-Dihydroxybenzoyl)
MM0133.04 2513-33-9 100mg OH
benzoic acid
OH
OH
Impurity C (EP): 2-(2,4-Dihydroxybenzoyl)benzoic O
MM0133.04- Acid
Related compound C (USP): 2-(2,4-Dihydroxybenzoyl)
2513-33-9 25mg OH
0025
benzoic acid
OH
Fluorometholone
O
HO OH
H
MM0870.00 Fluorometholone 426-13-1 250mg F H
O
Fluorouracil
O
F
MM0593.00- HN
Fluorouracil 51-21-8 250mg
0250
O N
H
H
Impurity A (EP): Pyrimidine-2,4,6-(1H,3H,5H)- O N O
trione (Barbituric Acid)
MM0265.03
Related compound A (USP): Pyrimidine-2,4,6(1H,3H,5H)-
67-52-7 100mg NH
trione
O
H
Impurity A (EP): Pyrimidine-2,4,6-(1H,3H,5H)- O N O
MM0265.03- trione (Barbituric Acid)
Related compound A (USP): Pyrimidine-2,4,6(1H,3H,5H)-
67-52-7 25mg NH
0025
trione
O
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-267
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
O
Impurity B (EP): Dihydropyrimidine-2,4,5(3H)-
O
MM0593.01- trione (Isobarbituric Acid or 5-Hydroxyuracil) HN
Related compound B (USP): Dihydropyrimidine-2,4,5(3H)-
496-76-4 25mg
0025
trione O N
H
O
O
Impurity D (EP): 5-Methoxypyrimidine-2,4(1H,3H)- HN
MM0593.04 6623-81-0 100mg
dione (5-Methoxyuracil)
O N
H
O
O
MM0593.04- Impurity D (EP): 5-Methoxypyrimidine-2,4(1H,3H)- HN
6623-81-0 25mg
0025 dione (5-Methoxyuracil)
O N
H
O
Impurity E (EP): 5-Chloropyrimidine-2,4(1H,3H)-
Cl
MM0593.05- dione (5-Chlorouracil) HN
Related compound E (USP): 5-Chloropyrimidine-2,4
1820-81-1 25mg
0025
(1H,3H)-dione O N
H
Fluoxetine Hydrochloride
H
O N
MM0256.00-
Fluoxetine Hydrochloride 56296-78-7 250mg F HCl
0250 F F
OH
Impurity A (EP): (1RS)-3-(Methylamino)-1- N
MM0256.01 42142-52-9 100mg
phenylpropan-1-ol H
OH
MM0256.01- Impurity A (EP): (1RS)-3-(Methylamino)-1- N
42142-52-9 25mg
0025 phenylpropan-1-ol H
(Methyl-3-phenylpropylamine Hydrochloride)
MM0256.02 30684-07-2 CS 100mg
Related compound B (USP): N-Methyl-3-phenylpropylamine
Impurity B (EP) as Hydrochloride: N-Methyl-3- H
N
MM0256.02- phenylpropan-1-amine Hydrochloride HCl
(Methyl-3-phenylpropylamine Hydrochloride)
30684-07-2 CS 25mg
0025
Related compound B (USP): N-Methyl-3-phenylpropylamine
Impurity C (EP) as Hydrochloride: (3RS)-N-
H
Methyl-3-phenyl-3-[3-(trifluoromethyl)- O N
HCl
MM0256.03 phenoxy]propan-1-amine Hydrochloride 79088-29-2 100mg
F
Related compound A (USP): N-methyl-3-phenyl-3-[(alpha, F
F
alpha, alpha-trifluoro-m-tolyl)oxy]propylamine
Impurity C (EP) as Hydrochloride: (3RS)-N-
H
MM0256.03- Methyl-3-phenyl-3-[3-(trifluoromethyl)- O N
HCl
phenoxy]propan-1-amine Hydrochloride 79088-29-2 25mg
F
0025 Related compound A (USP): N-methyl-3-phenyl-3-[(alpha, F
F
alpha, alpha-trifluoro-m-tolyl)oxy]propylamine
OH
F F
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-268
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
OH
MM0256.05-
4-Hydroxybenzotrifluoride 402-45-9 25mg F
0025
F F
Cl
F F
OH
OH
MM0256.10-
3-Dimethylamino-1-phenylpropan-1-ol 5554-64-3 25mg N
0025
O
O N
F F
F HCl
(3RS)-N-Methyl-3-phenyl-3-[2-(trifluoromethyl)- F
F
H
phenoxy]propan-1-amine Hydrochloride O N
MM0256.17
(2-Trifluoromethylisomer of Fluoxetine Hydro-
n/a 100mg
chloride)
F HCl
(3RS)-N-Methyl-3-phenyl-3-[2-(trifluoromethyl)- F
F
H
MM0256.17- phenoxy]propan-1-amine Hydrochloride O N
F F HO O
O N H2
MM0256.18- HO O
F F HO O
0025
OH
HO OH
OH
O O
HO
MM0256.19- Lactose Fluoxetine Amadori Rearrangement Product OH
OH
n/a 25mg O
O
N
0025 Hydrochloride F
HCl
F F
O N
MM0256.21-
885101-12-2 25mg F HCl
N-Methylfluoxetine Hydrochloride
0025 F F
O N O
MM0256.22- N
0025 F F
Fluoxymesterone
OH
HO
MM0959.00- H
Fluoxymesterone 76-43-7 250mg
0250 F H
O
Flupentixol Decanoate
F F
O
MM0182.08- Impurity B (BP): 2-Trifluoromethyl- S
1693-28-3 25mg
0025 thioxanthone
F
F F
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-269
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
OH
MM0182.05- N
1-(2-Hydroxyethyl)piperazine 103-76-4 100mg HN
0100
O
+
N CF3
MM0182.09 4-Fluoro-3-nitrobenzotrifluoride 367-86-2 100mg O
Flupentixol Dihydrochloride
OH
N
N
F
HCl
2
F F
F
0025 1-yl]ethyl Acetate Dihydrochloride (O-Acetylflupentixol F F
Dihydrochloride)
O
Impurity G (EP): 2-(Trifluoromethyl)-9H-
MM0182.08 thioxanthen-9-one (2-Trifluoromethyl- 1693-28-3 100mg S
thioxanthone) F
F F
O
MM0182.08- Impurity G (EP): 2-(Trifluoromethyl)-9H-
thioxanthen-9-one (2-Trifluoromethyl- 1693-28-3 25mg S
0025 thioxanthone) F
F F
OH
MM0182.05- N
1-(2-Hydroxyethyl)piperazine 103-76-4 100mg HN
0100
O
+ OH
N
N
MM0223.08-
Flupentixol N1-Oxide n/a 25mg S
0025 F
F F
(EZ)-3-[2-(Trifluoromethyl)-9H-thioxanthen-9-ylidene]propene
MM0223.15- S
Sulfoxide (9-Allylidene-2-(trifluoromethyl)thioxanthene 10- n/a 25mg O
0025
Oxide) F
F F
Fluphenazine Dihydrochloride
N N
F
N
OH HCl
2
F F
F
N
OH
piperazin-1-yl]propyl-2-(trifluoromethyl)-10H-phenothiazine 5-
F
N
OH
piperazin-1-yl]propyl-2-(trifluoromethyl)-10H-phenothiazine 5-
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-270
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
F
N
OH
piperazin-1-yl]propyl-2-(trifluoromethyl)-10H-phenothiazine
F F
3,1-diyl)]bis[2-(trifluoromethyl)-10H-phenothiazine] S
N
F F
F F
2376-89-8 25mg N
0025 3,1-diyl)]bis[2-(trifluoromethyl)-10H-phenothiazine] S
N
F F
10-yl]propyl]piperazin-1-yl]ethanol (Perphenazine) Cl
OH
O HCl
+ 2
N N
F F
O HCl
+ 2
N N
MM0114.04-
Fluphenazine N,N',S-Trioxide Dihydrochloride
+
S N
n/a 25mg O OH
O
F
0025
F F
MM0114.15- N N
+
HCl
S N 2
OH
Fluphenazine N1-Oxide Dihydrochloride n/a 25mg F
O
0025 F F
MM0114.13- N N O
S N
O-Acetylfluphenazine 2021-89-8 25mg O
F
0025 F F
N N
MM0114.17- S NH HCl
Desmethyltrifluoperazine Dihydrochloride 4617-82-7 25mg 2
F
0025
F F
O
+
N N
MM0114.18- Fluphenazine Sulfone N1,N4-Dioxide (Fluphenazine O S N
+
86137-45-3 25mg OH
O O
F
0025 N1,N4,S,S-Tetraoxide)
F F
NH
MM0441.10- O S
2-(Trifluoromethyl)-10H-phenothiazine 5,5-Dioxide 345-38-0 25mg
0025 O
F
F F
Flupirtine Maleate
F O
H
F
H
N N NH2
O
MM1245.04 Flupirtine 56995-20-1 100mg N O
H
F
H H
MM1245.02- 5-[(4-Fluorobenzyl)amino]-1H-imidazo[4,5-b]pyridin-2(3H)- N N N
951624-49-0 25mg O
0025 one N
H
Flurandrenolide
OH
O
HO O
H H
O
F
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-271
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
Flurazepam Dihydrochloride
N
O
N
MM3604.00-
Flurazepam Dihydrochloride 1172-18-5 CS 250mg N
HCl
2
Cl
0250
F
Flurazepam Monohydrochloride
N
O
N
Cl N
H O
Impurity B (EP): 7-Chloro-5-(2- N
fluorophenyl)-1,3-dihydro-2H-1,4-
Cl N
MM0070.02 benzodiazepin-2-one 2886-65-9 100mg
Related compound F (USP): 7-chloro-5-(2-fluorophenyl)- F
1,3-dihydro-2H-1,4-benzodiazepin-2-one
H O
Impurity B (EP): 7-Chloro-5-(2- N
fluorophenyl)-1,3-dihydro-2H-1,4-
MM0070.02- Cl N
benzodiazepin-2-one 2886-65-9 25mg
0025 Related compound F (USP): 7-chloro-5-(2-fluorophenyl)- F
1,3-dihydro-2H-1,4-benzodiazepin-2-one
2-Chloro-10-(2-diethylaminoethyl)-9,10- N
MM0070.03
dihydroacridin-9-one
97716-04-6 100mg
Cl
O
MM0070.03- 2-Chloro-10-(2-diethylaminoethyl)-9,10- N
dihydroacridin-9-one
97716-04-6 25mg
0025
Cl
O
O
N
Cl
MM0070.07-
2-Hydroxyethylflurazepam 20971-53-3 25mg
0025 N
F N
OH
O
Flurbiprofen
F OH
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-272
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
HO
F OH
Impurity C (EP): (2RS)-2-(2-Fluorobiphenyl-4-yl)- O
MM0727.03 61466-95-3 50mg
2-hydroxypropanoic Acid
F O
OH
F O
F O
MM0727.09-
Flurbiprofen Methyl Ester 66202-86-6 25mg O
0025
F O
F O
O OH
MM0727.11- Flurbiprofen 1,3-Butylene Glycol Esters (Mixture of Regio-
F O OH
n/a 25mg
and Stereoisomers) O
0025
OH
F O
MM0727.12-
Flurbiprofen 2,3-Butylene Glycol Ester 2731709-38-7 25mg O
0025
OH
F O OH
O
Flurbiprofen 1,2,3-Propanetriol Esters (Mixture of Regio- and F O
MM0727.13 n/a 100mg OH
O
Stereoisomers) OH
Flutamide
F F
H
N
MM0161.00- F
Flutamide 13311-84-7 250mg O +O
0250 N
O
F F
Impurity A (EP): 4-Nitro-3-(trifluoromethyl)- H 2N
aniline F
+O
MM0161.03 393-11-3 100mg
Related compound A (USP): 4-nitro-3-(trifluoromethyl) N
aniline O
F F
Impurity A (EP): 4-Nitro-3-(trifluoromethyl)- H 2N
MM0161.03- aniline F
+O
Related compound A (USP): 4-nitro-3-(trifluoromethyl)
393-11-3 25mg
0025 N
aniline O
phenyl]acetamide O
phenyl]acetamide O
F F
H
N
Impurity C (EP): N-[4-Nitro-3-(trifluoro- F
MM0161.05 13312-12-4 100mg O +O
methyl)phenyl]propanamide N
O
F F
H
N
MM0161.05- Impurity C (EP): N-[4-Nitro-3-(trifluoro- F
13312-12-4 25mg O +O
0025 methyl)phenyl]propanamide N
O
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-273
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
F F
F
MM0161.06 Impurity D (EP): 3-(Trifluoromethyl)aniline 98-16-8 100mg
N H2
F F
H
Impurity E (EP): 2-Methyl-N-[3-(trifluoro- N
F
MM0161.07 1939-27-1 100mg
methyl)phenyl]propanamide O
F F
H
MM0161.07- Impurity E (EP): 2-Methyl-N-[3-(trifluoro- N
F
1939-27-1 25mg
0025 methyl)phenyl]propanamide O
F F
H
MM0161.08- Impurity F (EP): 2-Methyl-N-[2-nitro-5- N
F
151262-93-0 25mg
0025 (trifluoromethyl)phenyl]propanamide O
O2N
HO F F
2-Hydroxy-2-methyl-N-[4-nitro-3- H
N
F
MM0161.01 (trifluoromethyl)phenyl]propanamide 52806-53-8 100mg O
N
+O
(2-Hydroxyflutamide) O
HO F F
MM0161.01- 2-Hydroxy-2-methyl-N-[4-nitro-3- H
N
F
(trifluoromethyl)phenyl]propanamide 52806-53-8 25mg O
N
+O
0025 (2-Hydroxyflutamide) O
F F
O F F
+
N
MM0161.10 3-Nitrobenzotrifluoride 98-46-4 100mg O F
F F
MM0161.11- F
2-Nitrotrifluoromethylbenzene 384-22-5 25mg
0025 +O
N
O
F F
HO
MM0161.12- F
3-Trifluoromethyl-4-nitrophenol 88-30-2 25mg +O
0025 N
O
Fluticasone Furoate
F
O S
O
O
MM3909.00- HO
0250 F H
O
F
Fluticasone Propionate
O
S
F
HO O
MM1244.00- H
Fluticasone Propionate 80474-14-2 250mg F H
O
0250 O
F
O
OH
Impurity A (EP): 6 ,9-Difluoro-11 -hydroxy-16 -methyl-3- HO O
MM1244.01- H
O
oxo-17-(propanoyloxy)androsta-1,4-diene-17 -carboxylic 65429-42-7 25mg F H
0025 O
Acid F
O
MM1244.04- Propanoate 73205-13-7 25mg
H
O
11beta-hydroxy-16alpha-methyl-3-oxo-17alpha- F
propionyloxyandrosta-1,4-diene-17beta-carbothioate
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-274
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
O
S
Impurity F (EP): 6 ,9-Difluoro-17-[[(fluoromethyl)- O O
F
MM1244.06- H
0025
androsta-1,4-dien-17 -yl Propanoate O
F
O
SH
HO O
MM1244.14- 6 ,9-Difluoro-11 -hydroxy-16 -methyl-3-oxo-17- H
O
80474-45-9 25mg F H
0025 (propanoyloxy)androsta-1,4-diene-17 -carbothioic Acid O
F
Flutrimazole
Fluvastatin Sodium
AND Enantiomer
O
+
Na
OH O
MM0676.00-
Fluvastatin Sodium 93957-55-2 250mg N
OH
0250
F
fluorophenyl)-1-methylethyl-1H-indol-2-yl]-3,5-dihydroxy-6-
heptenoic acid 1,1, dimethylethyl ester
Impurity B (EP) as Racemate: 1,1-Dimethylethyl
(3RS,5SR,6E)-7-[3-(4-Fluorophenyl)-1-(1-methylethyl)-1H- AND Enantiomer
fluorophenyl)-1-methylethyl-1H-indol-2-yl]-3,5-dihydroxy-6-
heptenoic acid 1,1, dimethylethyl ester
O
MM0676.01- N
OH
1H-indol-2-yl]-3-hydroxy-5-oxohept-6-enoic Acid (5- 1160169-39-0 25mg
0025
Ketofluvastatin) F
AND Enantiomer
O
OH O
N
OH
MM0676.09 Fluvastatin Methyl Ester 93957-53-0 100mg
F
AND Enantiomer
O
OH O
MM0676.09- N
OH
Fluvastatin Methyl Ester 93957-53-0 25mg
0025
F
AND Enantiomer
O
OH O
N
OH
MM0676.10 Fluvastatin Ethyl Ester 615263-37-1 100mg
F
AND Enantiomer
O
OH O
MM0676.10- N
OH
Fluvastatin Ethyl Ester 615263-37-1 25mg
0025
F
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-275
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
AND Enantiomer
O
OH O
MM0676.11- N
OH
Fluvastatin Isopropyl Ester 615263-39-3 25mg
0025
F
N
MM0676.14- O
(E)-3-[3-(4-Fluorophenyl)-1-(1-methylethyl)-1H-indol-2-yl]
93957-50-7 25mg
0025 prop-2-enal
F
Fluvoxamine Maleate
O O
N NH2
OH
O
F F
OH
N
F F
OH
N
F F
MM1439.00- OH
Maleic Acid 110-16-7 250mg
0250 OH
O N
O
OH
H2 N N N
H
O OH
OH
H 2N
NH2
MM0169.00- H 2N OH
L-Glutamine 56-85-9 250mg
0250 O O
O O
N
MM0621.09- N
6-Formylpterin 712-30-1 25mg
0025 H 2N N N
H
O
N
N OH
MM0621.10 6-Hydroxymethylpterin 712-29-8 50mg
H 2N N N
H
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-276
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
Formestane
O
AND Enantiomer
OH
H
N
O
Br
O
Br
MM0447.13-
1-(4-Benzyloxy-3-nitrophenyl)-2-bromoethanone 43229-01-2 25mg O
0025 +
N
O O
formic acid
Impurity D (EP): Ethyl (Diethoxyphosphoryl)formate O
O
ethoxycarbonylphosphonate O
Fosfomycin Calcium
O 2+
Ca
O
MM3457.00 Fosfomycin Calcium Monohydrate 26469-67-0 250mg P
H 2O
O O
Fosfomycin Trometamol
O
MM1566.01- +
Nitromethylidynetri(methanol) 126-11-4 25mg HO N O
0025 HO OH
Fosinopril Sodium
+
Na
O
O O
O
MM0645.00- H P
0250 O
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-277
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
acetic acid
MM0645.09- O O
P
[2-(Benzyloxy)-2-oxoethyl](4-phenylbutyl)phosphinic Acid 87460-09-1 25mg O
HO
0025
Fructose
Mixed
O
OH
MM1562.00 Fructose 57-48-7 250mg HO
&1
OH
HO OH
Fulvestrant
OH
Fulvestrant
H
O F F
H H
MM3296.00 129453-61-8 100mg HO
S
F F
F
OH
F F
F
Fumaric Acid
O
MM0460.10- HO
Fumaric Acid 110-17-8 250mg OH
0250 O
O
HO
MM0352.03 Monomethyl Fumarate 2756-87-8 100mg O
O
O
MM0352.03- HO
Monomethyl Fumarate 2756-87-8 25mg O
0025 O
Furaltadone
O
+
N
N
N O O
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-278
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
O
+
N
N
N O O
O
+
MM1753.02 Furaltadone N-Oxide Hydrochloride n/a 100mg N O HCl
O
O
+
N
MM1753.02- N
N O O
O
+
Furaltadone N-Oxide Hydrochloride n/a 25mg N O HCl
O
0025 O
Furosemide
Cl O O
S
MM0014.00- NH2
O
Furosemide 54-31-9 250mg N
0250 H
HO O
O OH
Impurity A (EP): 2-Chloro-4-[(furan-2-ylmethyl)amino]-5-
Cl
MM0014.02- sulphamoylbenzoic Acid
4818-59-1 25mg H 2N
0025 Related compound A (USP): 2-Chloro-4-N-furfurylamino-5- S
O O HN
sulfamoylbenzoic Acid O
O OH
Cl
Impurity B (EP): 2,4-Dichloro-5-
MM0014.03 2736-23-4 100mg
sulphamoylbenzoic Acid H 2N
S
O O Cl
O OH
Cl
MM0014.03- Impurity B (EP): 2,4-Dichloro-5-
2736-23-4 25mg
0025 sulphamoylbenzoic Acid H 2N
S
O O Cl
O OH
Impurity C (EP): 2-Amino-4-chloro-5-
N H2
MM0014.01- sulphamoylbenzoic Acid
Related compound B (USP): 4-Chloro-5-
3086-91-7 25mg H 2N
0025 S
sulfamoylanthranilic Acid O O Cl
O OH
H
Impurity D (EP): 2,4-Bis[(furan-2-ylmethyl)amino]- N
O
MM0014.04 5046-19-5 100mg H 2N
5-sulphamoylbenzoic Acid O
S
O HN
O
O OH
H
MM0014.04- Impurity D (EP): 2,4-Bis[(furan-2-ylmethyl)amino]- N
O
5046-19-5 25mg H 2N
0025 5-sulphamoylbenzoic Acid O
S
O HN
O
O OH
Cl
MM0014.05 Impurity E (EP): 2,4-Dichlorobenzoic Acid 50-84-0 100mg
Cl
O OH
H
Impurity F (EP): 4-Chloro-5-sulfamoyl-2-[[((2RS)- N
O
MM0014.07 4793-38-8 100mg
tetrahydrofuran-2-yl)methyl]amino]benzoic Acid H 2N
S
O O Cl
O OH
H
MM0014.07- Impurity F (EP): 4-Chloro-5-sulfamoyl-2-[[((2RS)- N
O
4793-38-8 25mg
0025 tetrahydrofuran-2-yl)methyl]amino]benzoic Acid H 2N
S
O O Cl
O O
Cl
MM0014.50 Ethyl 2,4-Dichloro-5-sulphamoylbenzoate 4793-25-3 100mg H 2N
S
O O Cl
O O
Cl
MM0014.50-
Ethyl 2,4-Dichloro-5-sulphamoylbenzoate 4793-25-3 25mg H 2N
0025 S
O O Cl
MM0877.31-
2-Hydroxymethylfuran 98-00-0 100mg HO
0100 O
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-279
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
Fusidic Acid
O
H OH
HO
O
H2 O
HO
H
2
Gabapentin
O
H2 N
O
H
N
Impurity A (EP): 2-Azaspiro[4.5]decan-3-one
MM0684.01-
(3,3-Pentamethylene-4-butyrolactam) 64744-50-9 25mg
0025 Related compound A (USP): 2-Azaspiro[4.5]decan-3-one
O O
Impurity E (EP): 1-(Carboxymethyl)cyclo- HO
MM0684.07- hexanecarboxylic Acid OH
Related compound E (USP): carboxymethyl-
67950-95-2 25mg
0025
cyclohexanecarboxylic acid
HO NH2
MM0684.03- O O
1,1-Cyclohexanediacetic Acid Monoamide 99189-60-3 25mg
0025
H
O N O
O
H2 N
MM0684.09 2-(1-Aminocyclohexyl)acetic Acid Hydrochloride 37631-92-8 100mg OH
O
H2 N
MM0684.09- OH
2-(1-Aminocyclohexyl)acetic Acid Hydrochloride 37631-92-8 25mg
0025
O
H2 N
MM0684.12- O HCl
Gabapentin Ethyl Ester Hydrochloride 60175-04-4 25mg
0025
O
H2 N
MM0684.14- O HCl
Gabapentin Methyl Ester Hydrochloride 63562-01-6 25mg
0025
Galantamine Hydrobromide
H
O OH
O
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-280
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
Gallamine Triethiodide
+
N
Gallamine Triethiodide
O
+ O O +
MM0140.00 65-29-2 250mg N N
I
3
Ganciclovir
O
HN N
HO
O
Impurity B (EP): (2RS)-2-[(2-Amino-6-oxo-1,6-dihydro-9H- HN
N
MM0485.03- N
H 2N N
purin-9-yl)methoxy]-3-hydroxy-propyl Propionate (Ganciclovir 194159-18-7 25mg O
0025 O
Monopropionate) HO O
N
Impurity C (EP): 2-Amino-9-[[(1RS)-2-chloro-1- HN
MM0485.04- N
(hydroxymethyl)ethoxy]methyl]-1,9-dihydro-6H-purin-6-one 108436-36-8 25mg H 2N N
0025 O
Cl
(Monochloroganciclovir) HO
O
H
Impurity F (EP): 2-Amino-1,9-dihydro-6H-purin- HN
N
MM0061.02 73-40-5 100mg
6-one (Guanine)
H 2N N N
HO
Impurity H (EP): 2-Amino-7-[[2-hydroxy-1-(hydroxy- O
MM0485.08- O OH
methyl)ethoxy]methyl]-1,7-dihydro-6H-purin-6- 84222-50-4 25mg HN
N
0025 one (N-7 Isomer of Ganciclovir) H2 N N N
N
Impurity I (EP): 2-[(2-Amino-6-oxo-1,6-dihydro- H 2N
HN
N N
N N
N
N N
N
N N
N
HN
MM0485.11- H 2N N N N HCl
Ganciclovir Mono-N-methyl Valinate Hydrochloride 1401562-16-0 25mg H
O O
0025 O
HO
N
HN
H2 N N N
MM0485.12 Ganciclovir Mono-O-acetate 88110-89-8 100mg O O
O
HO
N
HN
MM0485.12- N
Ganciclovir Mono-O-acetate 88110-89-8 25mg H2 N N
O O
0025 O
HO
N
HN
MM0485.13- H 2N N N
O O
Ganciclovir Di-O-acetate 86357-19-9 25mg O
0025 O
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-281
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
HN N
O
MM0485.14- N N N
H
Ganciclovir Triacetate 86357-14-4 25mg O O
0025 O O
O
2-[[2-(Acetylamino)-6-oxo-1,6-dihydro-9H-purin-9-yl] O HN
N
MM0485.15- N
N N
methoxy]-3-hydroxypropyl Acetate (Ganciclovir N,O- 298197-26-9 25mg H O O
0025 O
Diacetate) HO
HN N
O
MM0485.17- N-[9-[[2-Hydroxy-1-(hydroxymethyl)ethoxy]methyl]-6-oxo-1H- N
84245-12-5 25mg N N
H
O
0025 purin-2-yl]acetamide (Ganciclovir N-Acetate) OH
HO
Gatifloxacin
OH
1-Cyclopropyl-6,7-difluoro-1,4-dihydro-8-hydroxy-4-oxo-3- F N
MM0885.01 154093-72-8 100mg
quinolinecarboxylic Acid OH
F
O O
OH
MM0885.01- 1-Cyclopropyl-6,7-difluoro-1,4-dihydro-8-hydroxy-4-oxo-3- F N
154093-72-8 25mg
0025 quinolinecarboxylic Acid OH
F
O O
O
MM0885.16- 1-Cyclopropyl-6,7-difluoro-8-methoxy-4-oxo-1,4- F N
112811-71-9 25mg O
0025 dihydroquinoline-3-carboxylic Acid Ethyl Ester F
O O
Gefitinib
O N
Gefitinib
N O
O N
MM3563.02- Impurity A (EP): 7-Methoxy-6-[3-(morpholin-4-yl)propoxy] NH
199327-61-2 25mg N O
O O
0025 quinazolin-4(3H)-one
O N
MM3563.03- N
Impurity B (EP): N-(4-Chloro-3-fluorophenyl)-7-methoxy-6-[3- N O
1603814-04-5 25mg O HN F
0025 (morpholin-4-yl)propoxy]quinazolin-4-amine Cl
O N
O
+ N
N O
MM3563.01 Gefitinib N-Oxide 847949-51-3 100mg O HN Cl
H2 N Cl
MM3563.04-
3-Chloro-4-fluoroaniline 367-21-5 25mg
0025 F
O N
MM3563.05- N
4-Chloro-7-methoxyquinazolin-6-yl Acetate 230955-75-6 25mg O
0025 Cl
O
O N
N
MM3563.06- 4-[(3-Chloro-4-fluorophenyl)amino]-7-methoxyquinazolin-6-ol HO
184475-71-6 25mg HN Cl
0025 (O-Desmorpholinopropylgefitinib)
F
O N
MM3563.07- NH
6-(Acetyloxy)-7-methoxyquinazolin-4(3H)-one 179688-53-0 25mg O
0025 O
O
MM3563.09- N Cl
HCl
4-(3-Chloropropyl)morpholine Hydrochloride 57616-74-7 25mg O
0025
O
MM3563.11-
3-Hydroxy-4-methoxybenzaldehyde 621-59-0 25mg O
0025 HO
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-282
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
O
MM3563.12- O
4-Methoxy-3-[3-(morpholin-4-yl)propoxy]benzaldehyde 861453-11-4 25mg N O
O
0025
O N
N
MM3563.15- O
N-(3-Chloro-4-fluorophenyl)-6,7-dimethoxyquinazolin-4-amine 153437-78-6 25mg HN Cl
0025
F
O N
MM3563.22- N
4-Chloro-7-methoxy-6-[3-(morpholin-4-yl)propoxy]quinazoline 199327-59-8 25mg N O
0025 O Cl
O N
MM3563.23- NH
6-Hydroxy-7-methoxy-4(1H)-quinazolinone 179688-52-9 25mg HO
0025 O
Gemcitabine Hydrochloride
N H2
MM1257.00- O N
Gemcitabine Hydrochloride 122111-03-9 250mg F
HCl
0250 O F
HO OH
NH2
HN
Impurity C (EP): 1-(2-Deoxy-2,2-difluoro- -D-erythro-
O N
MM1257.04 pentofuranosyl)pyrimidin-2,4(1H,3H)-dione (2 -Deoxy-2 ,2 - 114248-23-6 100mg
F
difluorouridine) O F
HO OH
HN
Impurity C (EP): 1-(2-Deoxy-2,2-difluoro- -D-erythro-
MM1257.04- O N
pentofuranosyl)pyrimidin-2,4(1H,3H)-dione (2 -Deoxy-2 ,2 - 114248-23-6 25mg
F
0025 difluorouridine) O F
HO OH
HN
MM1257.05- O N OH
(6RS)-2'-Deoxy-2',2'-difluoro-5,6-dihydro-6-hydroxyuridine n/a 25mg
0025 F
O F
HO OH
NH
(3R,4R,6R)-5,5-Difluorohexahydro-4-hydroxy-3,6-Epoxy- O N O
MM1257.06 294177-31-4 25mg O
2H,8H-pyrimido[6,1-b][1,3]oxazocine-8,10(9H)-dione H
H F
HO F
MM1257.07- N NH O
N4-Acetylcytosine 14631-20-0 25mg
0025
N
H
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-283
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
O
O
O
MM1257.08- 2-Deoxy-2,2-difluoro-D-erythro-pentofuranos-1-ulose-3,5- O
122111-01-7 25mg F
0025 dibenzoate O F
O
O N
O NH2
O N
MM1257.09- O
2'-Deoxy-3',5'-di-O-benzoyl-2',2'-difluorocytidine 134790-39-9 25mg F
O F
0025
Gemfibrozil
O OH
MM0641.00 Gemfibrozil 25812-30-0 250mg O
OH
MM0641.08 Impurity A (EP): 2,5-Dimethylphenol (p-Xylenol) 95-87-4 100mg
OH
MM0641.08-
Impurity A (EP): 2,5-Dimethylphenol (p-Xylenol) 95-87-4 25mg
0025
1315604-10-4 25mg
0025 enyl]phenoxy]-2,2-dimethylpentanoic Acid O
500904-61-0 25mg O
0025 Related compound A (USP): (E,Z)-2,2-dimethyl-5-[2,5-
dimethyl-4-(propene-1-yl)phenoxy]valeric acid
Impurity H (EP): 1,3-Bis(2,5-dimethylphenoxy)- O O
415724-02-6 25mg
0025 propane
O Cl
3-(2,5-Dimethylphenoxy)propyl Chloride
(3-(2,5-Xylyloxy)propyl Chloride)
MM0641.01 31264-51-4 100mg
O O
MM0641.03 Gemfibrozil Isobutyl Ester 149105-26-0 100mg O
O O
O O
MM0641.15 Gemfibrozil Isopropyl Ester 154021-24-6 100mg O
Genistein
HO O
Gestodene
OH
MM0124.00-
Gestodene 60282-87-3 250mg H H
0250 H H
O
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-284
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
OH
Impurity L (EP): 13-Ethyl-17-hydroxy-18,19-
H H
MM0124.06 dinor-17 -pregna-5,15-dien-20-yn-3-one n/a 100mg
H H
( 6)-Gestodene) O
OH
Impurity L (EP): 13-Ethyl-17-hydroxy-18,19-
MM0124.06- H H
dinor-17 -pregna-5,15-dien-20-yn-3-one n/a 25mg
0025 H H
( 6)-Gestodene) O
O
MM1275.51-
0100
Gammabutyrolactone (GBL) 96-48-0 100mg O
Glibenclamide (Glyburide)
O O O
MM0008.00- S
O N N
H H
Cl
Glibenclamide 10238-21-8 250mg N
H
0250 O
(4-sulfamoylphenyl)ethyl]benzamide Cl
O
S
N H2
methoxybenzamido)ethyl]benzenesulfonamide
Impurity A (EP): 5-Chloro-2-methoxy-N-[2- O O
MM0008.01- (4-sulfamoylphenyl)ethyl]benzamide Cl
O
S
N H2
methoxybenzamido)ethyl]benzenesulfonamide
Impurity B (EP): Methyl [[4-[2-[(5-Chloro-2-
methoxybenzoyl)amino]ethyl]phenyl]- O
O
S
O
N
O
methoxybenzoyl)-amino]ethyl]phenyl]sulfonyl]carbamate
Impurity B (EP): Methyl [[4-[2-[(5-Chloro-2-
MM0008.02- methoxybenzoyl)amino]ethyl]phenyl]- O
O
S
O
N
O
methoxybenzoyl)-amino]ethyl]phenyl]sulfonyl]carbamate
Impurity C (EP): 1-Cyclohexyl-3-[[4-[2-
[(cyclohexylcarbamoyl)amino]ethyl]phenyl]sulfonyl]urea (N- O
O O
S
N
H
O
N
H
MM0942.09 10079-35-3 100mg
(Cyclohexylcarbamoyl)-4-[2-[(cyclohexylcarbamoyl)amino] N
H
N
H
ethyl]benzenesulphonamide)
Impurity C (EP): 1-Cyclohexyl-3-[[4-[2-
MM0942.09- [(cyclohexylcarbamoyl)amino]ethyl]phenyl]sulfonyl]urea (N- O
O O
S
N
H
O
N
H
10079-35-3 25mg
0025 (Cyclohexylcarbamoyl)-4-[2-[(cyclohexylcarbamoyl)amino] N
H
N
H
ethyl]benzenesulphonamide)
Impurity D (EP): 1-Butyl-3-[[4-[2-[(5-chloro-2- O
O O
methoxybenzoyl)amino]ethyl]phenyl]sulfonyl]urea (1-[[4-[2- Cl
O
N
S
N
H
N
H
MM0008.07 38160-73-5 50mg
[(5-Chloro-2-methoxybenzoyl)amino]ethyl]phenyl]sulfonyl]-3- O
H
butylurea)
Impurity E (EP): 1-Cyclohexyl-3-[[4-[2-[(3,5-dichloro-2- O O O
N
S
N
H
N
H
57334-89-1 25mg
[(3,5-Dichloro-2-methoxybenzoyl)amino]ethyl]phenyl]
H
O
0025 Cl
sulfonyl]-3-cyclohexylurea)
O
Cl
MM0008.03 5-Chloro-2-methoxybenzoic Acid 3438-16-2 100mg OH
O
MM0008.03- Cl
5-Chloro-2-methoxybenzoic Acid 3438-16-2 25mg OH
0025
O
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-285
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
O
5-Chloro-N-(2-phenylethyl)-2- Cl
N
methoxybenzamide
MM0008.04 33924-49-1 100mg H
O
Gliclazide
O O O
MM0325.00-
Gliclazide 21187-98-4 250mg S
N
H
N
H
N
0250
O O
S
MM0325.01 Impurity A (EP): 4-Methylbenzenesulphonamide 70-55-3 100mg NH2
O O O
Impurity C (EP): Ethyl [(4-Methylphenyl)sulphonyl]- S
N O
MM0325.03 5577-13-9 100mg H
carbamate
O O O
MM0325.03- Impurity C (EP): Ethyl [(4-Methylphenyl)sulphonyl]- S
N O
5577-13-9 25mg
0025 carbamate H
O O O
S
MM0325.09 Methyl N-Methyl-p-tolylsulphoncarbamate 32258-50-7 100mg N O
O O O
MM0325.09- S
Methyl N-Methyl-p-tolylsulphoncarbamate 32258-50-7 25mg N O
0025
HCl
MM0325.10 Octahydrocyclopenta[c]pyrrole Hydrochloride 112626-50-3 100mg
HN
MM0325.10- HCl
Octahydrocyclopenta[c]pyrrole Hydrochloride 112626-50-3 25mg
0025 HN
O O O
N-Carbamoyl-2-methylbenzenesulfonamide (N- S
MM0325.11 39051-77-9 100mg N NH2
H
(Aminocarbonyl)-2-methylbenzenesulfonamide)
O O O
MM0325.11- N-Carbamoyl-2-methylbenzenesulfonamide (N- S
39051-77-9 25mg N NH2
H
0025 (Aminocarbonyl)-2-methylbenzenesulfonamide)
Glimepiride
O O O
S
MM0647.00- N N
0250 O N
H
methylcyclohexyl)urea (cis-Glimepiride) O N
H
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-286
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
N
NH2
Ethyl-4-methyl-2-oxo-N-(4-sulfamoylphenethyl)-2,5-dihydro-
1H-pyrrole-1-carboxamide
Impurity B (EP): 3-Ethyl-4-methyl-2-oxo-N-[2-(4-
sulphamoylphenyl)ethyl]-2,3-dihydro-1H-pyrrole- O O
S
MM0647.01- 1-carboxamide (Glimepiride Sulphonamide) N
O
N
NH2
Ethyl-4-methyl-2-oxo-N-(4-sulfamoylphenethyl)-2,5-dihydro-
1H-pyrrole-1-carboxamide
Impurity C (EP): Methyl [[4-[2-[[(3-Ethyl-4-methyl-2-
oxo-2,3-dihydro-1H-pyrrol-1-yl)carbonyl]amino]-
ethyl]phenyl]sulphonyl]carbamate (Glimepiride O
O
S
O
N
O
O
H
((4-(2-(3-ethyl-4-methyl-2-oxo-2,5-dihydro-1H-pyrrole-1-
carboxamido)ethyl)phenyl)sulfonyl)carbamate
Impurity D (EP): 1-[[3-[2-[[(3-Ethyl-4-methyl-2-oxo-
2,3-dihydro-1H-pyrrol-1-yl)carbonyl]amino]ethyl]-
phenyl]sulphonyl]-3-(trans-4-methylcyclohexyl)- O
S
O
N
O
urea
H H
[2-(3-Ethyl-4-methyl-2-oxo-3-pyrroline-1-carboxamido)ethyl]
phenyl]sulfonyl]-3-(trans-4-methylcyclohexyl)urea
Impurity D (EP): 1-[[3-[2-[[(3-Ethyl-4-methyl-2-oxo-
2,3-dihydro-1H-pyrrol-1-yl)carbonyl]amino]ethyl]-
MM0647.04- phenyl]sulphonyl]-3-(trans-4-methylcyclohexyl)- O
S
O
N
O
urea
H H
791104-62-6 25mg N
H
N
0025 Related compound D (USP): Glimepiride 3-isomer, or 1-[[m- O O
[2-(3-Ethyl-4-methyl-2-oxo-3-pyrroline-1-carboxamido)ethyl]
phenyl]sulfonyl]-3-(trans-4-methylcyclohexyl)urea
HCl
MM0647.08 cis-4-Methylcyclohexylamine Hydrochloride 33483-66-8 100mg H2 N
MM0647.08- HCl
cis-4-Methylcyclohexylamine Hydrochloride 33483-66-8 25mg H2 N
0025
MM0647.17- 3-Ethyl-4-methyl-2-oxo-N-(2-phenylethyl)-2,5-dihydro-1H-
247098-18-6 25mg O
N
0025 pyrrole-1-carboxamide
O N
H
Glipizide
O O O
MM0942.00- S
Glipizide
O N N
H H
N
29094-61-9 250mg N
H
0250 N
phenyl)ethyl]pyrazine-2-carboxamide N
O
S
N H2
ethyl-5-methyl-pyrazinecarboxamide
Impurity A (EP): 5-Methyl-N-[2-(4-sulphamoyl- O O
MM0942.01- phenyl)ethyl]pyrazine-2-carboxamide N
O
S
N H2
ethyl-5-methyl-pyrazinecarboxamide
N H2
MM0678.03 Impurity B (EP): Cyclohexanamine 108-91-8 100mg
phenyl)ethyl]pyrazine-2-carboxamide N
O
S
N H2
sulphamoylphenyl)ethyl]pyrazine-2-carboxamide
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-287
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
MM0942.04- phenyl)ethyl]pyrazine-2-carboxamide N
O
S
N H2
sulphamoylphenyl)ethyl]pyrazine-2-carboxamide
Impurity E (EP): 1-Cyclohexyl-3-[[4-[2-[[(6-methyl-
pyrazin-2-yl)carbonyl]amino]ethyl]phenyl]- O O
S
O
sulphonyl]urea
O N N
H H
N
MM0942.05 66375-96-0 100mg N
H
methylpyrazin-2-yl)carbonyl]amino]ethyl]phenyl]sulfonyl]urea
Impurity E (EP): 1-Cyclohexyl-3-[[4-[2-[[(6-methyl-
MM0942.05- pyrazin-2-yl)carbonyl]amino]ethyl]phenyl]- O O
S
O
sulphonyl]urea
O N N
H H
N
66375-96-0 25mg N
H
0025 Related compound C (USP): 1-cyclohexyl-3-[[4-[2-[[(6- N
methylpyrazin-2-yl)carbonyl]amino]ethyl]phenyl]sulfonyl]urea
O O
O O
MM0942.06- Impurity F (EP): Ethyl [2-(4-Sulphamoylphenyl)- O
S
N H2
192118-08-4 25mg
0025 ethyl]carbamate O N
H
N
O
carbamate N
N
O
0025 carbamate N
O O
O O
MM0942.08- Impurity H (EP): 4-[2-[(Cyclohexylcarbamoyl)amino]- O
S
N H2
10080-05-4 25mg
0025 ethyl]benzenesulphonamide N
H
N
H
N
H
N
H
N
H
sulphonamide
N
H
N
H
N
H
0025 sulphonamide
O O
MM0942.10- S
N H2
4-(2-Aminoethyl)benzenesulfonamide 35303-76-5 25mg
0025 H 2N
Gliquidone
O O O
S
O N N
O
H H
Glucosamine Hydrochloride
HO
O
HO N H2
N
MM0695.06 2-Methylpyrazine 109-08-0 100mg N
Glucose Monohydrate
Mixed
HO
O
MM0178.00 Glucose Monohydrate 14431-43-7 250mg HO &1
OH H2O
HO OH
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-288
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
Glutamic Acid
NH2
HO OH
MM1333.00 Glutamic Acid (L-Glutamic Acid) 56-86-0 250mg
O O
Glutamine
NH2
MM0169.00- H 2N OH
L-Glutamine 56-85-9 250mg
0250 O O
N-Phenylacetyl-L-glutamine HN
MM0169.01 28047-15-6 100mg
(Phenylacetylglutamine) H 2N OH
O O
MM0169.01- N-Phenylacetyl-L-glutamine HN
(Phenylacetylglutamine)
28047-15-6 25mg H 2N OH
0025 O O
NH2
NH2
MM0169.02-
Phenylacetamide 103-81-1 25mg O
0025
O
H
N
O
MM3413.01 Pidolic Acid (Pyroglutamic Acid) 98-79-3 250mg
OH
Glutathione
SH
O O O
H
Glycerol (Glycerin)
OH
MM1481.00 Impurity C (EP): (RS)-Propane-1,2-diol (Propylene Glycol) 57-55-6 250mg OH
Glycine
OH
MM1509.00- H 2N
Glycine 56-40-6 250mg
0250 O
O O
H
MM1509.01 Impurity A (EP): 2,2 -Iminodiacetic Acid (Iminodiacetic Acid) 142-73-4 100mg HO
N
OH
MM1509.01- O O
H
Impurity A (EP): 2,2 -Iminodiacetic Acid (Iminodiacetic Acid) 142-73-4 25mg HO
N
OH
0025
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-289
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
H
N O
H
N O
MM0314.04-
Impurity B (EP): Piperazine-2,5-dione (Glycine Anhydride) 106-57-0 25mg
0025
O N
H
O
MM1509.02- Impurity H (EP): 2-[(2-Aminoacetyl)amino]acetic Acid H
N
556-50-3 100mg H 2N OH
0100 (Diglycine; N-Glycylglycine) O
O O
MM1509.03- Impurity I (EP): 2-[[2-[(2-Aminoacetyl)amino]acetyl]amino] H 2N
N
H
N
OH
556-33-2 25mg
0025 acetic Acid (Triglycine) H
O
MM1509.04- O
H2 N HCl
Glycine Ethyl Ester Hydrochloride 623-33-6 25mg O
0025
Glycocholic Acid
O
OH
H
MM3875.00- N OH
H H
O
Glycocholic Acid 475-31-0 250mg H H
0250 HO OH
H
O
OH
H
MM3875.01- N O
H H
O
Glycocholic Acid Ethyl Ester 517904-33-5 25mg H H
0025 HO OH
H
O
OH
H
OH
MM0835.02- H
3 ,7 ,12 -Trihydroxy-5 -cholan-24-oic Acid (Cholic Acid) 81-25-4 250mg H H
0250 HO
H
OH
O
OH
H
MM3875.02- N OH
H H
O
Glycodeoxycholic Acid 360-65-6 25mg H H
0025 HO
H
O
OH
H
MM3875.03- N O
H H
O
Glycodeoxycholic Acid Ethyl Ester 70779-06-5 25mg H H
0025 HO
H
MM1509.04- O
H2 N HCl
Glycine Ethyl Ester Hydrochloride 623-33-6 25mg O
0025
O
Impurity B (EP): Oxophenylacetic Acid
MM0834.05
(Benzoylformic Acid)
611-73-4 100mg OH
O
O
MM0834.05- Impurity B (EP): Oxophenylacetic Acid
(Benzoylformic Acid)
611-73-4 25mg OH
0025
O
O
Impurity C (EP): (2RS)-2-Hydroxy-2-phenylacetic
MM0792.03
Acid (Mandelic Acid)
90-64-2 100mg OH
OH
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-290
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
O
MM0278.01-
Impurity D (EP): Benzoic Acid 65-85-0 250mg OH
0250
MM0528.05- O
Impurity F (EP): Benzaldehyde 100-52-7 500mg
0500
MM0834.09- 2-hydroxy-2-phenylacetate O
Related compound L (USP): Methyl 2-cyclopentyl-2-
19833-96-6 25mg OH
0025
hydroxy-2-phenylacetate
O
MM0834.06 Impurity M (EP): Cyclopentylphenylmethanone 5422-88-8 100mg
AND Enantiomer
Glymidine Sodium
O
O O N O
Na
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-291
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
Granisetron Hydrochloride
H
N N
MM0398.00- H
N N HCl
Granisetron Hydrochloride 107007-99-8 250mg
O
0250 H
azabicyclo[3.3.1]non-3-yl]-1H-indazole-3-carboxamide
Impurity C (EP): N-[(1R,3r,5S)-9-Azabicyclo[3.3.1]non-3-yl]- H
N
H
Impurity E (EP): (1R,3r,5S)-9-Methyl-9-azabicyclo[3.3.1]
nonan-3-amine H 2N N
MM0398.05
Related compound E (USP): (1R,3r,5S)-9-methyl-9-
76272-56-5 100mg
azabicyclo[3.3.1]nonan-3-amine acetate H
azabicyclo[3.3.1]nonan-3-amine acetate
N N
N N
MM0398.07-
Impurity G (EP): 2-Methyl-2H-indazole-3-carboxylic Acid 34252-44-3 25mg OH
0025
O
H
N N
MM0398.08-
Impurity H (EP): 1H-Indazole-3-carboxylic Acid 4498-67-3 25mg OH
0025
O
n/a 25mg
0025 Anhydride O O
H
N N
H +
N O N
MM0398.11 Granisetron N-Oxide 160177-68-4 50mg
O
H
Griseofulvin
Cl O
O O
O O
Guaiacol
OH
MM0354.04 Guaiacol 90-05-1 500mg
O
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-292
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
OH
Impurity A (EP): Benzene-1,2-diol
MM0814.04 120-80-9 100mg
(Pyrocatechol)
OH
OH
MM0814.04- Impurity A (EP): Benzene-1,2-diol
120-80-9 25mg
0025 (Pyrocatechol)
OH
OH
MM0045.11 Impurity B (EP): Phenol 108-95-2 100mg
O
Impurity C (EP): 1,2-Dimethoxybenzene
MM0814.06 91-16-7 100mg
(Veratrole)
O
O OH
OH
MM0641.08 2,5-Dimethylphenol (p-Xylenol) 95-87-4 100mg
OH
MM0641.08-
2,5-Dimethylphenol (p-Xylenol) 95-87-4 25mg
0025
OH
MM1132.04-
4-Methylphenol (p-Cresol) 106-44-5 100mg
0100
OH
MM0146.01 2,6-Dimethylphenol 576-26-1 100mg
MM0146.01- OH
2,6-Dimethylphenol 576-26-1 25mg
0025
Guaifenesin
OH
O OH
MM0354.00 Guaifenesin 93-14-1 500mg
O
OH
MM0354.04 Impurity A (EP): 2-Methoxyphenol (Guaiacol) 90-05-1 500mg
O
HO OH
Impurity B (EP): 2-(2-Methoxyphenoxy)- O
MM0354.01 14007-09-1 100mg
propane-1,3-diol (B-Isomer)
O
HO OH
MM0354.01- Impurity B (EP): 2-(2-Methoxyphenoxy)- O
14007-09-1 25mg
0025 propane-1,3-diol (B-Isomer)
O
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-293
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
(Bisether)
OH
MM0354.03- Impurity D (EP): 1,3-Bis(2-methoxyphenoxy)- O O
16929-60-5 25mg
0025 propan-2-ol O O
O
MM0354.09- O
O
4-[(2-Methoxyphenoxy)methyl]-1,3-dioxolan-2-one 2049-21-0 25mg
0025
O
Guanoxan Sulfate
NH
O O O
Halcinonide
Cl
O
HO O
F H
O
Halobetasol Propionate
Cl
O O
HO O
H
O
F
Halofantrine Hydrochloride
Cl
F F
Cl F
HO N
Cl
F F
MM0433.05- Cl F
Halometasone Monohydrate
O
HO OH
OH
MM3688.00- H
F H
H2O
0250 O
F
Haloperidol
F
Cl
OH
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-294
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
yl]-1-[4-[4-(4-chlorophenyl)-4-hydroxypiperidin-1-yl]phenyl]
MM1165.04 butan-1-one 67987-08-0 100mg HO
N
N
Cl
hydroxypiperidino]-butyrophenone
Impurity D (EP): 4-[4-(4-Chlorophenyl)-4-hydroxypiperidin-1- Cl
MM1165.04- yl]-1-[4-[4-(4-chlorophenyl)-4-hydroxypiperidin-1-yl]phenyl]
butan-1-one 67987-08-0 25mg HO
N
N
Cl
hydroxypiperidino]-butyrophenone
Haloperidol Decanoate
F
Cl
N
Harmine
NH
NH
MM2562.01-
Tetrahydroharmine 17019-01-1 25mg
0025 O N
H
Harpagoside
O
O
MM0370.01-
Methyl trans-Cinnamate 1754-62-7 25mg O
0025
Heptaminol Hydrochloride
NH2
MM0653.01 Impurity A (EP): (2RS)-6-Methylhept-5-en-2-amine 22462-79-9 100mg
Heteronium Bromide
O
+
N Br
Hexachlorophene
OH OH
Cl Cl
Hexestrol
OH
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-295
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
Hexetidine
NH2
(Dehydrohexetidine)
Impurity C (EP): 2,6-Bis(2-ethylhexyl)-7a-methyl-
N
MM0337.03 hexahydro-1H-imidazo[1,5-c]imidazole 5980-31-4 100mg N N
(Hexedine)
Hexobarbital
O N O
Hexylresorcinol
HO OH
OH
MM0045.11 Impurity A (EP): Phenol 108-95-2 100mg
HO OH
MM0294.01-
Impurity B (EP): Resorcinol 108-46-3 250mg
0250
Histamine Dihydrochloride
N
Histamine Phosphate
N O OH
Histapyrrodine
Histidine
N NH2
HN
OH
MM1526.00 Histidine (L-Histidine) 71-00-1 250mg
O
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-296
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
Homatropine Hydrobromide
HBr
AND Enantiomer
H
Homatropine Hydrobromide
O
H
MM1649.00 51-56-9 100mg N
O
OH
H
AND Enantiomer
H
MM1649.02- O
H +
Homatropine N-Oxide Hydrochloride n/a 25mg O N HCl
O
0025 OH
H
Homatropine Hydrochloride
AND Enantiomer
H
O
Homatropine Hydrochloride
H
N
MM3214.00 637-21-8 100mg O
OH
H
HCl
Homatropine Methylbromide
AND Enantiomer
H Br
Homatropine Methylbromide
O
H +
MM0792.00 80-49-9 250mg N
O
OH
H
O
Impurity C (EP): (2RS)-2-Hydroxy-2-phenylacetic
MM0792.03
Acid (Mandelic Acid)
90-64-2 100mg OH
OH
dimethyl-3-oxa-9-azoniatricyclo[3.3.1.02,4]-
155-41-9 250mg
OH H H
0250
nonane Bromide (Methylhyoscine Bromide)
O
Impurity F (EP): Methyl (2RS)-2-Hydroxy-2-
MM0792.06 4358-87-6 100mg O
phenylacetate (Methyl Mandelate)
OH
O
MM0792.06- Impurity F (EP): Methyl (2RS)-2-Hydroxy-2-
4358-87-6 25mg O
0025 phenylacetate (Methyl Mandelate)
OH
Homosalate
OH
Hydrochlorothiazide
O O O O
S S
MM0011.00- H 2N NH
Hydrochlorothiazide 58-93-5 250mg
0250 Cl N
H
O O O O
S S
MM0011.03 Impurity A (EP): Chlorothiazide 58-94-6 500mg H2 N NH
Cl N
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-297
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
Dioxide
O O O O
S S
MM0011.05- H2 N NH
5-Chlorohydrochlorothiazide 5233-42-1 25mg Cl N
0025 H
Cl
O O O O
S S
MM0011.07- H2 N NH2
4-Amino-5,6-dichlorobenzene-1,3-disulfonamide 5250-72-6 25mg Cl NH2
0025
Cl
O O O H2O
2 5
OH
H2O
MM0442.00 41444-62-6 CS 100mg O
N
Impurity E (EP): 7,8-Didehydro-4,5 -epoxy-3-
H
MM0004.02 methoxy-17-methylmorphinan-6-one 467-13-0 100mg
(Codeinone)
O O O
N
Impurity F (EP): 7,8-Didehydro-4,5 -epoxy-
H
MM0004.03 3,6 -dimethoxy-17-methylmorphinan 2859-16-7 CS 100mg
(Methylcodeine; O-Methylcodeine) O
O O
O
Impurity H (EP): Diphenylmethanone
MM0630.01 119-61-9 100mg
(Benzophenone)
O
MM0630.01- Impurity H (EP): Diphenylmethanone
119-61-9 25mg
0025 (Benzophenone)
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-298
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
N
Impurity K (EP) as Hydrochloride: 4,5 -Epoxy-3-hydroxy-17-
MM0371.00- H HCl
methylmorphinan-6-one Hydrochloride (Hydromorphone 71-68-1 CS 250mg
0250
Hydrochloride) HO O O
O +
N
H
MM1113.17 Hydrocodone N-Oxide 909265-05-0 100mg
O O O
O +
N
MM1113.17- H
Hydrocodone N-Oxide 909265-05-0 25mg
0025
O O O
Hydrocortisone
O
OH
HO OH
MM0185.00-
Hydrocortisone (Cortisol) 50-23-7 250mg H
0250 H H
O
O
OH
HO OH
MM0193.00-
Impurity A (EP): Prednisolone 50-24-8 250mg H
0250 H H
O
O
OH
Impurity B (EP): 17,21-Dihydroxypregn-4-ene- O
H
OH
O
O
50-03-3 250mg
0250 (Hydrocortisone 21-Acetate) H H
O
H
MM0185.06 pregn-4-ene-3,20-dione 53-35-0 100mg H H
(6 -Hydroxyhydrocortisone) O
OH
MM0185.06- H
pregn-4-ene-3,20-dione 53-35-0 25mg H H
0025
(6 -Hydroxyhydrocortisone) O
OH
O
OH
Impurity E (EP): 11 ,17,21-Trihydroxypregna- HO
H
OH
O
OH
MM0185.07- Impurity E (EP): 11 ,17,21-Trihydroxypregna- HO
H
OH
600-99-7 25mg
0025 4,6-diene-3,20-dione ( -Hydrocortisone) H H
O
O
OH
Impurity F (EP): 17,21-Dihydroxypregn-4- H
OH
O
OH
MM0185.08- Impurity F (EP): 17,21-Dihydroxypregn-4- H
OH
152-58-9 25mg
0025 ene-3,20-dione (Reichstein's Substance S) H H
O
O
OH
HO O
MM0187.01- Impurity J (EP): 11 ,21-Dihydroxy-3,20-dioxopregn-4-en-17- H
16463-74-4 25mg O
0025 yl Acetate (Hydrocortisone 17-Acetate) H H
O
0025 21-Acetate) O
H H
O
OH
MM0185.15- Impurity M (EP): 11 ,17,21-Trihydroxypregn-4- HO
H
OH
566-35-8 25mg
0025 ene-3,20-dione (Epihydrocortisone) H H
O
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-299
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
O
OH
HO OH
H
MM0185.13 6 -Hydroxyhydrocortisone 2242-98-0 50mg H H
O
OH
O
OH
MM0185.35- 17,21-Dihydroxy-9 ,1 -epoxypregn-4-ene-3,20-dione OH
O
10072-97-6 25mg
0025 (9 ,11 -Epoxyhydrocortisone) H H
O
Hydrocortisone Acetate
O
O
O
MM0187.00- HO OH
Hydrocortisone Acetate 50-03-3 250mg H
0250 H H
O
O
OH
MM0185.00- Impurity A (EP): 11 ,17,21-Trihydroxypregn-4-ene-3,20- HO
H
OH
50-23-7 250mg
0250 dione (Hydrocortisone) H H
O
O
O
52-21-1 250mg
0250 dien-21-yl Acetate (Prednisolone Acetate) H H
O
O
O
50-04-4 250mg
0250 Acetate (Cortisone Acetate) H H
O
O
OH
HO O
MM0187.01-
Hydrocortisone 17-Acetate 16463-74-4 25mg H
O
0025 H H
O
O
O O
O
MM0187.06- O O
Hydrocortisone 11,17,21-Triacetate 3517-51-9 25mg H
O
0025 H H
O
O
O
O
11 ,17,21-Trihydroxypregna-4,6-diene- HO
H
OH
MM0187.09 21940-45-4 100mg
3,20-dione 21-Acetate H H
O
O
O
O
MM0187.09- 11 ,17,21-Trihydroxypregna-4,6-diene- HO
H
OH
21940-45-4 25mg
0025 3,20-dione 21-Acetate H H
O
Hydrocortisone Butyrate
O
OH
HO O
O
O
O
HO OH
H H
O
O
O
O
MM0188.01- HO OH
0025 H H
O
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-300
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
O
OH
HO OH
MM0185.00-
Impurity A (EP): Hydrocortisone 50-23-7 250mg H
0250 H H
O
O
O
O
MM0187.00- HO OH
Impurity B (EP): Hydrocortisone Acetate 50-03-3 250mg H
0250 H H
O
Hydroflumethiazide
O O O O
S S
H 2N NH
MM3099.00 Hydroflumethiazide 135-09-1 100mg F
N
H
F F
Hydromorphone Hydrochloride
N
MM0371.00-
Hydromorphone Hydrochloride 71-68-1 CS 250mg H HCl
0250
HO O O
O +
Impurity B (EP) as Hydrochloride: 4,5 -Epoxy-3-hydroxy-17- N
hydrate HO O OH
2
7,8-Didehydro-4,5 -epoxy-3-hydroxy-17-methylmorphinan-6- N
N
HCl
HO
MM0272.00 Naloxone Hydrochloride Dihydrate 51481-60-8 250mg H2O
2
HO O O
Hydroquinidine Hydrochloride
H
H
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-301
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
Hydroxycarbamide (Hydroxyurea)
O
MM0895.00-
Hydroxycarbamide 127-07-1 250mg OH
0250 H 2N N
H
O O
MM0895.05-
3-Hydroxybiuret 4381-13-9 25mg H2 N N NH2
0025 OH
Hydroxychloroquine Sulphate
O O
Cl N S
HO OH
MM0764.00-
Hydroxychloroquine Sulphate 747-36-4 250mg HN
N
OH
0250
(Desethylhydroxychloroquine Dihydrochloride)
(Desethylhydroxychloroquine Dihydrochloride)
Cl N
Cl N
MM0617.03-
Impurity G (EP): 4,7-Dichloroquinoline 86-98-6 25mg
0025
Cl
Cl N
Hydroxyethyl Salicylate
O
MM0112.00- OH
Hydroxyethyl Salicylate 87-28-5 100mg O
0100 OH
O
MM0045.00- OH
Impurity A (EP): Salicylic Acid 69-72-7 250mg
0250
OH
OH
MM0112.02 Impurity B (EP): Ethane-1,2-diol (Ethylene Glycol) 107-21-1 100mg HO
Hydroxyphenamate
HO
O NH2
MM3109.00 Hydroxyphenamate 50-19-1 100mg
O
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-302
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
Hydroxyprogesterone Caproate
O O
MM1548.00- O
H
0250 O
Hydroxyzine Hydrochloride
Cl O
N OH
N
Cl
Impurity A (EP): (RS)-1-[(4-Chlorophenyl)- NH
N
phenylmethyl]piperazine
MM0380.01
Related compound A (USP): 1-[(4-Chlorophenyl)
303-26-4 100mg
phenylmethyl]piperazine
Cl
Impurity A (EP): (RS)-1-[(4-Chlorophenyl)- NH
N
MM0380.01- phenylmethyl]piperazine
303-26-4 25mg
0025 Related compound A (USP): 1-[(4-Chlorophenyl)
phenylmethyl]piperazine
Impurity B (EP) as Dihydrochloride: 2-[2-[4- O
N OH
MM0852.02- (Diphenylmethyl)piperazin-1-yl]ethoxy]- N
HCl
13073-96-6 25mg 2
Cl
MM0380.10-
4-Chlorobenzophenone 134-85-0 25mg
0025 O
Cl
Hydroxyzine Pamoate
Cl O
N OH O OH HO O
Hydroxyzine Pamoate
N HO OH
Hymecromone
HO O O
HO OH
MM0294.01- Impurity A (EP): 1,3-Dihydroxybenzene
108-46-3 250mg
0250 (Resorcinol)
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-303
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
HO O
Impurity B (EP): 7-Hydroxy-2-methyl-4H-1-
MM0294.02 6320-42-9 100mg
benzopyran-4-one
O
HO O
MM0294.02- Impurity B (EP): 7-Hydroxy-2-methyl-4H-1-
6320-42-9 25mg
0025 benzopyran-4-one
O
HO OH
MM0294.03-
2,4-Dihydroxyacetophenone 89-84-9 25mg O
0025
O O O
MM0294.04-
Hymecromone Acetate 2747-05-9 25mg O
0025
O O
MM0294.50- 7-Acetoxy-3-acetyl-2-4H-1-benzopyran- O
52751-48-1 25mg
0025 4-one O O
Hyoscine Butylbromide
H H
O
MM0683.00- H +
Br
Hyoscine Butylbromide
N O
O
149-64-4 250mg OH H H
0250
H
O
Impurity B (EP): (2RS)-3-Hydroxy-2-phenylpropanoic
MM0601.03 552-63-6 100mg OH
Acid (DL-Tropic Acid; Tropic Acid)
OH
O
MM0601.03- Impurity B (EP): (2RS)-3-Hydroxy-2-phenylpropanoic
552-63-6 25mg OH
0025 Acid (DL-Tropic Acid; Tropic Acid)
OH
22235-98-9 25mg OH H H
0025 phenylpropanoate Hydrochloride (N-Butylnorhyoscine
Hydrochloride)
Impurity G (EP) as Bromide: (1R,2R,4S,5S,7s,9r)-9-Butyl-9-
H H
O
H +
MM0683.07- methyl-7-[(2-phenylprop-2-enoyl)oxy]-3-oxa-9-azatricyclo O
N O Br
92714-23-3 25mg H H
0025 [3.3.1.02,4]nonan-9-ium Bromide (Apo-N-Butylhyoscine
Bromide; Apohyoscine Butylbromide)
H H
H +
MM0683.06- N O Br
HO
N-Butylscopine Bromide 2030294-83-6 25mg
0025 H H
AND Enantiomer
MM0683.09- (1s,3RS,4RS,5RS,7SR)-4-Hydroxy-6-butyl-6-methyl-2-oxa-6- H
+
azoniatricyclo[3.3.1.03,7]nonane Bromide
n/a 25mg N
0025 H H Br
O
H OH
H
O
H2 O
3
OH H
H
O
H
MM1699.00 Impurity A (EP): Hyoscyamine 101-31-5 100mg O
N
OH H
H
MM0546.06 9-azatricyclo[3.3.1.02,4]non-7-yl 2-Phenylprop- 535-26-2 100mg O
N O
H
2-enoate (Apohyoscine) H
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-304
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
H
9-azatricyclo[3.3.1.02,4]non-7-yl 2-Phenylprop- 535-26-2 25mg O
N O
H
0025 2-enoate (Apohyoscine) H
O
Impurity D (EP): (2RS)-3-Hydroxy-2-phenylpropanoic
MM0601.03 552-63-6 100mg OH
Acid (DL-Tropic Acid; Tropic Acid)
OH
O
MM0601.03- Impurity D (EP): (2RS)-3-Hydroxy-2-phenylpropanoic
552-63-6 25mg OH
0025 Acid (DL-Tropic Acid; Tropic Acid)
OH
H H
O
H
H
OH H
H H
O
MM0546.07- H
H
0025 OH H
AND Enantiomer
H H
H
MM0546.09 Scopine 498-45-3 100mg N O
HO
H H
AND Enantiomer
H H
MM0546.09- H
Scopine 498-45-3 25mg N O
HO
0025 H H
AND Enantiomer
H H
H
MM0546.11 Scopine Hydrochloride 85700-55-6 100mg N O HCl
HO
H H
AND Enantiomer
H H
MM0546.11- H
Scopine Hydrochloride 85700-55-6 25mg N O HCl
HO
0025 H H
Hyoscyamine
H
O
H
MM1699.00 Hyoscyamine 101-31-5 100mg O
N
OH H
Hyoscyamine Sulfate
H
O
H
N
MM1699.00 Hyoscyamine 101-31-5 100mg O
OH H
O
Impurity A (EP): (2RS)-3-Hydroxy-2-
MM0601.03 phenylpropanoic Acid (DL-Tropic Acid; 552-63-6 100mg OH
Tropic Acid)
OH
O
MM0601.03- Impurity A (EP): (2RS)-3-Hydroxy-2-
phenylpropanoic Acid (DL-Tropic Acid; 552-63-6 25mg OH
0025 Tropic Acid)
OH
H
MM0289.01 8-azabicyclo[3.2.1]oct-3-yl 2-Phenylprop-2-enoate 5978-81-4 100mg O
N HCl
H
O
MM0794.09- H
O N
+
HCl
Hyoscyamine N-Oxide Hydrochloride 200721-88-6 25mg O
0025 OH H
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-305
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
O
0250
0025
propanoic acid
MM1326.03- N
3-[N-Methyl(pentyl)amino]propanenitrile 919491-64-8 100mg N
0100
OH
O OH
MM1326.06- HO P
OH
N-Desmethylibandronate Sodium 953805-81-7 25mg N
H
P O
Na
+
0025 O
H
MM1326.10- N
3-(Methylamino)propanenitrile 693-05-0 100mg
0100 N
Ibogaine Hydrochloride
N
O H
MM1901.00 Ibogaine Hydrochloride 5934-55-4 100mg N
H
HCl
Ibrutinib
NH2
Ibufenac
OH
Ibuprofen
OH
MM0002.00 Ibuprofen 15687-27-1 500mg
O
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-306
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
O
Impurity E (EP): 1-[4-(2-Methylpropyl)phenyl]-
MM0002.04 ethanone 38861-78-8 100mg
Related compound C (USP): 4-isobutylacetophenone
O
Impurity F (EP): 3-[4-(2-Methylpropyl)phenyl]- OH
MM0002.28 65322-85-2 100mg
propanoic Acid
O
MM0002.28- Impurity F (EP): 3-[4-(2-Methylpropyl)phenyl]- OH
65322-85-2 25mg
0025 propanoic Acid
AND Enantiomer
O OH
naphthalene-1,4-dicarboxylic Acid O
(1-Hydroxyibuprofen) OH
HO
Impurity M (EP): (2RS)-2-Hydroxy-2-[4-(2- OH
MM0002.34 60057-62-7 100mg
methylpropyl)phenyl]propanoic Acid O
HO
MM0002.34- Impurity M (EP): (2RS)-2-Hydroxy-2-[4-(2- OH
60057-62-7 25mg
0025 methylpropyl)phenyl]propanoic Acid O
OH
Impurity O (EP): 2-[4-(1-Methylpropyl)-
MM0002.33 64451-76-9 100mg O
phenyl]propanoic Acid
OH
MM0002.33- Impurity O (EP): 2-[4-(1-Methylpropyl)-
64451-76-9 25mg O
0025 phenyl]propanoic Acid
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-307
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
O
MM0002.03-
4-Isobutylbenzoic Acid 38861-88-0 25mg OH
0025
N H2
N H2
MM0002.07-
2-(4-Isobutyrylphenyl)propanamide 1823308-53-7 25mg O
0025 O
OH
MM0002.08 4-Acetylbenzoic Acid 586-89-0 100mg
O
MM0002.08- OH
4-Acetylbenzoic Acid 586-89-0 25mg
0025
O
MM0002.09-
4-Isobutyrylacetophenone 103931-20-0 25mg
0025
O
OH
2-Hydroxypropyl 2-(4-Isobutylphenyl)- O
propanoate
MM0002.15 95093-58-6 100mg O
OH
2,3-Dihydroxypropyl 2-(4- O OH
Isobutylphenyl)propanoate
MM0002.17 64622-21-5 50mg O
OH
MM0002.20 2-(4-n-Propylphenyl)propanoic Acid 3585-47-5 100mg
O
MM0002.20- OH
2-(4-n-Propylphenyl)propanoic Acid 3585-47-5 25mg
0025 O
O
MM0002.23 Isopropyl 2-(4-Isobutylphenyl)propanoate 64622-17-9 100mg O
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-308
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
AND Enantiomer
O OH
(1RS,4SR)-7-(2-Methylpropyl)-1-[4-(2-methyl-
MM0002.29 propyl)phenyl]-1,2,3,4-tetrahydronaphthalene- 2517611-89-9 100mg OH
1,4-dicarboxylic Acid O
AND Enantiomer
O OH
MM0002.29- (1RS,4SR)-7-(2-Methylpropyl)-1-[4-(2-methyl-
propyl)phenyl]-1,2,3,4-tetrahydronaphthalene- 2517611-89-9 25mg OH
0025 1,4-dicarboxylic Acid O
2-[4-(2-Hydroxy-2-methylpropyl)- OH
MM0002.32 phenyl]propanoic Acid (2-Hydroxy- 51146-55-5 100mg O
ibuprofen) HO
MM0002.32- 2-[4-(2-Hydroxy-2-methylpropyl)- OH
phenyl]propanoic Acid (2-Hydroxy- 51146-55-5 25mg O
0025 ibuprofen) HO
MM0002.41- H
N
N-( -Phenylethyl)ibuprofenamide 105959-56-6 25mg O
0025
AND Enantiomer
(2SR)-2-(4-Isobutylphenyl)-N-((SR)-1- 121734-80-3 and H
N
MM0002.45 100mg
phenylethyl)propanamide 81576-52-5 O
AND Enantiomer
MM0002.45- (2SR)-2-(4-Isobutylphenyl)-N-((SR)-1- 121734-80-3 and H
N
25mg
0025 phenylethyl)propanamide 81576-52-5 O
AND Enantiomer
(2SR)-2-(4-Isobutylphenyl)-N-((RS)-1- 121734-79-0 and H
N
MM0002.46 100mg
phenylethyl)propanamide 81576-47-8 O
AND Enantiomer
MM0002.46- (2SR)-2-(4-Isobutylphenyl)-N-((RS)-1- 121734-79-0 and H
N
25mg
0025 phenylethyl)propanamide 81576-47-8 O
MM0002.49- O
(2RS)-2-[4-(2-Methylpropyl)phenyl]propan-1-al 51407-46-6 100mg
0100
4-(1-Hydroxy-2-methylpropyl)-
MM0002.51
acetophenone
1314907-71-5 100mg
OH
O
MM0002.53 Ibuprofen Methyl Ester 61566-34-5 100mg O
O
MM0002.56 Ibuprofen Ethyl Ester 41283-72-1 100mg O
1-(4-Isopropylphenyl)ethanone
MM0002.57 645-13-6 100mg
(4-Isopropylacetophenone)
OH
MM0002.59-
2-(4-Isopropylphenyl)acrylic Acid 1368714-46-8 25mg O
0025
MM0002.61- OH
2-(4-Isobutylphenyl)prop-2-enoic Acid 6448-14-2 25mg
0025 O
O OH
Ibuprofen 1,3-Butylene Glycol Esters (Mixture of Regio- and
MM0002.62 n/a 100mg
Stereoisomers) O OH
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-309
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
OH
O
MM0002.63 Ibuprofen 2,3-Butylene Glycol Ester 95093-59-7 100mg O
OH
O
O
Ibuprofen 1,2-Propylene Glycol Esters (Mixture of Regio- and
MM0002.64 n/a 100mg
Stereoisomers) O
OH
O
OH
O OH
O
Ibuprofen 1,2,3-Propanetriol Esters (Mixture of Regio- and
MM0002.65 n/a 100mg
Stereoisomers) O
OH
O
OH
MM0002.66- OH
2-[4-(2-Methylpropenyl)phenyl]propionic Acid 75625-99-9 25mg O
0025
MM0002.74- H 2N HCl
-Phenylethylamine Hydrochloride 13437-79-1 25mg
0025
O
MM0002.75- O
Isopropyl 4-Acetylbenzoate 220089-22-5 100mg
0100
O
Icaridin
O
OH
Idoxuridine
H
O N O
N
MM0791.00 Idoxuridine 54-42-2 500mg O
I
HO
HO
Ifosfamide
Cl
O
O
MM0292.00 Ifosfamide 3778-73-2 250mg P N
H
N
Cl
Ilaprazole
MM3745.01- O
Cl HCl
2-(Chloromethyl)-4-methoxy-3-methylpyridine Hydrochloride 86604-74-2 25mg N
0025
Iloperidone
F
HN
HCl
MM3659.01 (2,5-Difluorophenyl)-(4-piperidyl)methanone Hydrochloride 1172297-96-9 100mg
O F
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-310
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
MM3659.01- HN
HCl
(2,5-Difluorophenyl)-(4-piperidyl)methanone Hydrochloride 1172297-96-9 25mg
0025
O F
O
O
MM3659.02 1-(4-Hydroxy-3-methoxyphenyl)propan-1-one 1835-14-9 100mg
OH
O
MM3659.02- O
1-(4-Hydroxy-3-methoxyphenyl)propan-1-one 1835-14-9 25mg
0025 OH
HN
MM3659.08- OH
1,2,3,6-Tetrahydropyridine-4-carboxylic Acid (Isoguvacine) 64603-90-3 25mg
0025
O
MM3659.05-
1-(2-Hydroxy-3-methoxyphenyl)ethanone 703-98-0 25mg OH
0025
O
Imatinib
N
H H
N N N N N
Imatinib Mesilate
N
Imatinib Mesilate
H H O O
N N N N N
S
OH
MM3566.00 220127-57-1 250mg O N
N
H H
N N N N N
O
Impurity A (EP): (2E)-3-(Dimethylamino)-1-(pyridin-3-yl)prop- N N
MM3566.03 123367-26-0 100mg
2-en-1-one
O
MM3566.03- Impurity A (EP): (2E)-3-(Dimethylamino)-1-(pyridin-3-yl)prop- N N
123367-26-0 25mg
0025 2-en-1-one
N
MM3566.13- Impurity B (EP): N-(3-Carbamimidamido-4-methylphenyl)-4- N
H
N
H
N N H2
581076-65-5 25mg O NH
0025 [(4-methylpiperazin-1-yl)methyl]benzamide
HN
MM1265.01 Impurity G (Pharmeuropa): 1-Methylpiperazine 109-01-3 100mg
N
H
MM0056.06 N-Methylmethanamine Hydrochloride 506-59-2 100mg N HCl
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-311
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
O
2-Methyl-5-nitro-N-[4-(pyridin-3-yl)pyrimidin-2-yl] +
H
N N N N
MM3566.04 152460-09-8 100mg O
N
benzenamine
O
MM3566.04- 2-Methyl-5-nitro-N-[4-(pyridin-3-yl)pyrimidin-2-yl] +
H
N N N N
152460-09-8 25mg O
N
0025 benzenamine
N
N O
MM3566.07 Methyl 4-[(4-Methylpiperazin-1-yl)methyl]benzoate 314268-40-1 100mg
O
N
MM3566.07- N O
Methyl 4-[(4-Methylpiperazin-1-yl)methyl]benzoate 314268-40-1 25mg
0025 O
Cl
MM3566.08- 4-(Chloromethyl)-N-[4-methyl-3-[[4-(pyridin-3-yl)pyrimidin-2- H
N
H
N N N
404844-11-7 25mg O N
0025 yl]amino]phenyl]benzamide
MM3566.09- N
4-[(4-Formyl-1-piperazinyl)methyl]-N-[4-methyl-3-[[4-(3- O N
H
N
H
N N N
1436868-85-7 25mg O N
0025 pyridinyl)-2-pyrimidinyl]amino]phenyl]benzamide
O
MM3566.12- 4-Formyl-N-[4-methyl-3-[[4-(3-pyridinyl)-2-pyrimidinyl]amino] H
N
H
N N N
1219828-35-9 25mg O N
0025 phenyl]benzamide
N
MM3566.14- 4-[(4-Methylpiperazin-1-yl)methyl]benzoic Acid N OH
HCl
2
106261-49-8 25mg O
0025 Dihydrochloride
MM3566.15- N
3-[(4-Methyl-1-piperazinyl)methyl]-N-[4-methyl-3-[[4-(3- N
H
N
H
N N N
1246819-59-9 25mg O N
0025 pyridinyl)-2-pyrimidinyl]amino]phenyl]benzamide
NH O
MM3566.16- O + N
+
1-(2-Methyl-5-nitrophenyl)guanidine Nitrate 152460-08-7 25mg N N N H2 HO O
H
O
0025
H
MM3566.17- 4-[(4-Methyl-1-piperazinyl)methyl]-N-[3-methyl-4-[[4-(3- N N N
O
N
1026753-54-7 25mg N
N
N
H
0025 pyridinyl)-2-pyrimidinyl]amino]phenyl]benzamide
O
+
O N
MM3566.19- N
N O
MM3566.21- +
N
+ H H
O N N N N N
e Imatinib N1,N4-Dioxide 571186-93-1 25mg O N
w
0025
MM3566.25- N
4-[(4-Acetyl-1-piperazinyl)methyl]-N-[4-methyl-3-[[4-(3- N
H
N
H
N N N
1321600-77-4 25mg O O N
0025 pyridinyl)-2-pyrimidinyl]amino]phenyl]benzamide
O
MM3566.26- N
N-[3-[Acetyl[4-(3-pyridinyl)-2-pyrimidinyl]amino]-4- N
H
N N N N
1321600-78-5 25mg O N
0025 methylphenyl]-4-[(4-methyl-1-piperazinyl)methyl]benzamide
MM3566.28- 4-Methyl-N-[4-methyl-3-[[4-(pyridin-3-yl)pyrimidin-2-yl]amino] H H
N N N N
152459-96-6 25mg O N
0025 phenyl]benzamide
N
H H
MM3566.32- N-[[(5-Amino-2-methylphenyl)amino]iminomethyl]-4-[(4- N N N
2753049-11-3 25mg O NH
N H2
MM0563.02 2-Methylbenzenamine (o-Toluidine) 95-53-4 100mg
Imipramine Hydrochloride
MM0077.00- N N HCl
Imipramine Hydrochloride 113-52-0 250mg
0250
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-312
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
0025 Dihydrochloride
N N
MM0077.04 10-Hydroxyimipramine BH3-Aduct 20438-96-4 100mg BH 3
HO
MM0077.04- N N
10-Hydroxyimipramine BH3-Aduct 20438-96-4 25mg BH 3
0025 HO
NH
MM0076.06 Iminodibenzyl 494-19-9 100mg
MM0076.06- NH
Iminodibenzyl 494-19-9 25mg
0025
+
N N
MM0077.12 Imipramine N-Oxide 6829-98-7 100mg O
Imiquimod
N
MM1158.00 Imiquimod 99011-02-6 250mg N
N N H2
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-313
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
N
MM1158.01- N
Imiquimod N-Oxide 1807607-22-2 25mg
0025
+
N NH2
O
1-Isobutyl-1H-imidazo[4,5-c]quinoline (Desaminoimiquimod)
N
MM1158.02 Related compound A (USP): 1-Isobutyl-1H-imidazo[4,5-c] 99010-24-9 100mg N
quinoline
N
1-Isobutyl-1H-imidazo[4,5-c]quinoline (Desaminoimiquimod)
MM1158.02- N
Related compound A (USP): 1-Isobutyl-1H-imidazo[4,5-c] 99010-24-9 25mg N
0025
quinoline
N
1-Isobutyl-1H-imidazo[4,5-c]quinoline 5-Oxide
N
(Desaminoimiquimod N-Oxide) N
MM1158.03 99010-63-6 100mg
Related compound B (USP): 1-Isobutyl-1H-imidazo[4,5-c]
quinoline 5-oxide +
N
O
1-Isobutyl-1H-imidazo[4,5-c]quinoline 5-Oxide
N
MM1158.03- (Desaminoimiquimod N-Oxide) N
99010-63-6 25mg
0025 Related compound B (USP): 1-Isobutyl-1H-imidazo[4,5-c]
quinoline 5-oxide +
N
O
4-Chloro-1-isobutyl-1H-imidazo[4,5-c]quinoline
N
MM1158.04 Related compound C (USP): 4-Chloro-1-isobutyl-1H-imidazo 99010-64-7 100mg N
[4,5-c]quinoline
N Cl
4-Chloro-1-isobutyl-1H-imidazo[4,5-c]quinoline
MM1158.04- N
Related compound C (USP): 4-Chloro-1-isobutyl-1H-imidazo 99010-64-7 25mg N
0025
[4,5-c]quinoline
N Cl
1-Propyl-1H-imidazo[4,5-c]quinolin-4-amine
MM1158.05- N
Related compound D (USP): 1-Propyl-1H-imidazo[4,5-c] 853792-81-1 25mg N
0025
quinolin-4-amine
N N H2
N4-Isobutylquinoline-3,4-diamine
NH
MM1158.06 Related compound E (USP): N4-Isobutylquinoline-3,4- 99010-09-0 100mg NH2
diamine
N
N4-Isobutylquinoline-3,4-diamine
MM1158.06- NH
Related compound E (USP): N4-Isobutylquinoline-3,4- 99010-09-0 25mg NH2
0025
diamine
N
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-314
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
N4-Isobutylquinoline-3,4-diamine Hydrochloride
NH
HCl
MM1158.07 Related compound E (USP): N4-Isobutylquinoline-3,4- 935521-01-0 100mg NH2
diamine N
N4-Isobutylquinoline-3,4-diamine Hydrochloride
MM1158.07- NH
HCl
Related compound E (USP): N4-Isobutylquinoline-3,4- 935521-01-0 25mg NH2
0025
diamine N
Indanazoline Hydrochloride
MM0588.02-
4-Aminoindan Hydrochloride 2172482-73-2 25mg HCl
0025 NH2
Indapamide
O O O
Cl
1-yl)-3-sulfamoylbenzamide
Impurity B (EP): 4-Chloro-N-(2-methyl-1H-
O
MM0477.02- indol-1-yl)-3-sulphamoylbenzamide H 2N
O O
S
N
N
1-yl)-3-sulfamoylbenzamide
Impurity C (EP) as Hydrochloride: (2RS)-2-Methyl-2,3-
dihydro-1H-indol-1-amine Hydrochloride (1-Amino-2- N HCl
methylindoline Hydrochloride)
MM0477.09 31529-47-2 100mg H 2N
acid Cl
O
MM0477.04- 4-Chloro-3-sulfamoylbenzoic Acid O O
S
Related compound E (USP): 4-Chloro-3-sulfamoylbenzoic 1205-30-7 25mg H 2N OH
0025 acid Cl
O O O
N-(4-Chloro-3-sulfamoylbenzoyl)-2- H2 N
S
N
methylindoline
MM0477.05 n/a 100mg
Cl
O O O
MM0477.05- N-(4-Chloro-3-sulfamoylbenzoyl)-2- H2 N
S
N
methylindoline
n/a 25mg
0025 Cl
MM0477.06-
2-Methylindole 95-20-5 25mg HN
0025
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-315
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
2-Methylindoline
MM0477.08
Related compound C (USP): 2-Methylindoline
6872-06-6 100mg HN
Indometacin (Indomethacin)
O
OH
N
O
Impurity A (EP): 4-Chlorobenzoic Acid OH
Related compound B (USP): 4-chlorobenzoic acid
MM0063.03 74-11-3 100mg
Cl
O
MM0063.03- Impurity A (EP): 4-Chlorobenzoic Acid OH
Related compound B (USP): 4-chlorobenzoic acid
74-11-3 25mg
0025
Cl
O
Cl OH
Impurity G (EP): [1-(3,4-Dichlorobenzoyl)-5-methoxy-2- N
MM0584.02- O
402849-26-7 25mg Cl
0025 methyl-1H-indol-3-yl]acetic Acid (3,4-Dichloroindometacin) O
O
O
Impurity H (EP): Methyl [1-(4-Chlorobenzoyl)-5-methoxy-2- N
O
MM0584.08 1601-18-9 100mg Cl
methyl-1H-indol-3-yl]acetate (Indomethacin Methyl Ester)
O
O
O
MM0584.08- Impurity H (EP): Methyl [1-(4-Chlorobenzoyl)-5-methoxy-2- N
O
1601-18-9 25mg Cl
O
O
Impurity I (EP): Ethyl [1-(4-Chlorobenzoyl)-5-methoxy-2- N
O
MM0584.09 16401-99-3 100mg Cl
methyl-1H-indol-3-yl]acetate (Indomethacin Ethyl Ester)
O
O
O
MM0584.09- Impurity I (EP): Ethyl [1-(4-Chlorobenzoyl)-5-methoxy-2- N
O
16401-99-3 25mg Cl
O
O
N
O
MM0584.11 Indomethacin Isopropyl Ester 72616-25-2 100mg Cl
O
O
N
MM0584.11- O
Indomethacin Isopropyl Ester 72616-25-2 25mg Cl
0025 O
O
O
N
O OH
Cl
MM0584.12- O
0025 O OH
N
O
Cl
O OH
O
N
MM0584.13- O
Indometacin 2,3-Butylene Glycol Ester 87293-45-6 25mg Cl
0025 O
O OH
O
N
O
Cl
MM0584.14- O
O OH
O OH
N
O
Cl
MM0584.15- O
0025 O
N OH
O
Cl OH
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-316
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
Indoramin Hydrochloride
H
N
H
N
MM0802.02-
Impurity A (BP): 3-(2-Bromoethyl)indole 3389-21-7 25mg
0025
Br
H
MM0802.04- N
Impurity C (BP): N-(4-Piperidyl)benzamide 33953-37-6 25mg
0025 HN O
myo-Inositol
OH
OH
HO
MM0654.00 Impurity A (EP): D-Mannitol (Mannitol) 69-65-8 250mg OH
OH
HO
Iodipamide
O I
NH2
MM3337.01 3-Amino-2,4,6-triiodobenzoic Acid 3119-15-1 100mg HO
I I
O I
MM3337.01- NH2
3-Amino-2,4,6-triiodobenzoic Acid 3119-15-1 25mg HO
0025
I I
Iohexol
OH
H
O N OH
I I
I O
HO O
MM1468.02- dihydroxypropyl)-2,4,6-triiodobenzene-1,3-dicarboxamide I I
OH
31127-80-7 25mg H
N OH
0025 Related compound A (USP): 5-(acetylamino)-N,N'-bis(2,3- HN
I O
O
dihydroxypropyl)-2,4,6-triiodo-1,3-benzenedicarboxamide
Impurity J (EP): 5-Amino-N,N -bis(2,3-dihydroxypropyl)- O
H
N
OH
OH
MM1468.03- 2,4,6-triiodobenzene-1,3-dicarboxamide I I
OH
Related compound B (USP): 5-amino-N,N'-bis(2,3-
76801-93-9 25mg H
N OH
0025 H2 N
dihydroxypropyl)-2,4,6-triiodo-1,3-benzenedicarboxamide I O
OH
H
N,N'-Bis(2,3-dihydroxypropyl)-5-nitro-1,3- O N OH
OH
H
MM1468.01- N,N'-Bis(2,3-dihydroxypropyl)-5-nitro-1,3- O N OH
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-317
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
Iopamidol
HO OH
O NH
OH OH
Impurity A (EP): 5-Amino-N,N'-bis[2-hydroxy-1-
(hydroxymethyl)ethyl]-2,4,6-triiodobenzene-1,3- O NH
MM0838.01-
dicarboxamide 60166-98-5 25mg I I
0025 H
N
Related compound A (USP): N,N'-Bis-(1,3-dihydroxy-2- H2 N OH
I O
OH
propyl)-5-amino-2,4,6-triiodoiso-phthalamide
Iopydol
I
N OH
Ioversol
OH
H
Ioxaglic Acid
O OH
22871-58-5 25mg H
N
0025 2,4,6-triiodobenzoic Acid HO N H2
O I
Ioxilan
3-Amino-5-[(2-hydroxyethyl)carbamoyl]-2,4,6-triiodobenzoic O OH
MM3588.01- Acid I I
22871-58-5 25mg H
N
0025 Related compound A (USP): 5-amino-2,4,6-triiodo-3 N-(2- HO N H2
O I
hydroxyethyl)carbamoyl benzoic acid
Ipecacuanha
N
O
O
Ipragliflozin
S
F
MM3943.00-
Ipragliflozin 761423-87-4 250mg
0250 O
OH
HO
HO OH
Ipratropium Bromide
Mixed
H
O
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-318
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
O
MM0289.03-
Impurity D (EP): 2-Phenylpropenoic Acid (Atropic Acid) 492-38-6 25mg OH
0025
AND Enantiomer
H
MM1249.05- Impurity E (EP): (1R,3r,5S)-8-(1-Methylethyl)-8-azabicyclo O
H
N
22235-81-0 25mg O
0025 H
Iproniazid Phosphate
O
H
N O OH
Irbesartan
O N N
HN N
N
[1,1'-biphenyl]-2-carbonitrile
O
N
MM0862.03- 4'-[(2-Butyl-4-oxo-1,3-diazaspiro[4.4]non-1-en-3-yl)methyl] N
138401-24-8 25mg N
0025 [1,1'-biphenyl]-2-carbonitrile
O
MM0862.04- NH
HCl
2-Butyl-1,3-diazaspiro[4.4]non-1-en-4-one Hydrochloride 151257-01-1 25mg N
0025
O
MM0862.05- HCl
Ethyl 1-Aminocyclopentanecarboxylate Hydrochloride 22649-37-2 25mg O
0025 NH2
O N N
HN N
MM0862.07- 3-[[2'-(1H-Tetrazol-5-yl)biphenyl-4-yl]methyl]-1,3-diazaspiro N
1312996-18-1 25mg N
H
O
0025 [4.4]nonane-2,4-dione
N
MM0862.08-
4'-Methylbiphenyl-2-carbonitrile 114772-53-1 25mg
0025
N
MM0487.09A N O
N-Nitrosodimethylamine 0.2 mg/ml in Methanol 62-75-9 1ml
ME-00.20
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-319
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
N
MM0487.10A N O
N-Nitrosodiethylamine (NDEA) 0.1 mg/ml in Methanol 55-18-5 1ml
ME-00.10
O N N
HN N
MM0862.21- N-[[2'-(1H-Tetrazol-5-yl)[1,1'-biphenyl]-4-yl]methyl] N
H
914465-68-2 25mg
0025 pentanamide
MM0862.28- 2-Butyl-3-[[2'-[2-(triphenylmethyl)-2H-tetrazol-5-yl][1,1'- O N N
886999-35-5 25mg N N
N
0025 biphenyl]-4-yl]methyl]-1,3-diazaspiro[4.4]non-1-en-4-one N
Irganox 245
O
O
MM3895.01-
Ethyl 3-(3-tert-Butyl-4-hydroxy-5-methylphenyl)propionate 40200-35-9 25mg HO
0025
O
O HCl
MM1157.00 136572-09-3 100mg N
N
O
N HO
MM1157.02- N O
Hydroxycamptothecin; (S)-10-Hydroxycamptothecin) 19685-09-7 25mg O
N HO
0025 HO
MM1157.01- hydroxycamptothecin) OH
86639-52-3 25mg N
0025 Related compound B (USP): (S)-4,11-diethyl-4,9-dihydroxy-
HO
1H-pyrano[3',4':6,7]indolizino[1,2-b]quinoline-3,14(4H,12H)-
dione
MM1157.07- N NH
1,4'-Bipiperidine (4-Piperidinopiperidine) 4897-50-1 25mg
0025
MM1330.03- N O
N
O
0025
O
Ester
Isavuconazonium Sulfate
N
N N
HO S
N
MM3613.01 Isavuconazole 241479-67-4 100mg F
N
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-320
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
N N
MM3613.01- HO S
N
Isavuconazole 241479-67-4 25mg F
N
0025 F
Isoamyl Benzoate
O
Isobutyl p-Aminobenzoate
O
H2 N
Isoconazole Nitrate
Cl
O
MM0541.00- Cl Cl
Isoconazole Nitrate 24168-96-5 250mg O
HO N
+
O
0250 N
Cl
N
Cl
Impurity A (EP): (1RS)-1-(2,4-Dichlorophenyl)-
MM0281.01 24155-42-8 100mg N
2-(1H-imidazol-1-yl)ethanol Cl OH
N
Cl
MM0281.01- Impurity A (EP): (1RS)-1-(2,4-Dichlorophenyl)-
24155-42-8 25mg N
0025 2-(1H-imidazol-1-yl)ethanol Cl OH
N
Cl
O
dichlorophenyl)ethanamine Nitrate O
NH2
Cl
Cl
O
0025 dichlorophenyl)ethanamine Nitrate O
NH2
Cl
Cl
22832-87-7 250mg
0250 ethyl]-1H-imidazole Nitrate O
N
O
Cl Cl
(Miconazole Nitrate) N
Isoflurane
Cl F
MM0500.00- F
Isoflurane 26675-46-7 250mg O F
0250
F F
Cl Cl F F
Impurity E (EP): 1,1-Dichloro-1-
F
MM0500.05 (chlorodifluoromethoxy)-2,2,2- 32778-09-9 100mg O Cl
trifluoroethane F F
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-321
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
Isoleucine
NH2
OH
MM1564.00 Isoleucine (L-Isoleucine) 73-32-5 250mg
O
Isoniazid
O
MM1529.00- NH2
Isoniazid 54-85-3 250mg N
H
0250 N
N
MM0553.03- OH
Impurity A (EP): Pyridine-4-carboxylic Acid (Isonicotinic Acid) 55-22-1 25mg
0025
O
O
MM0552.01-
Impurity B (EP): Pyridine-4-carboxamide (Isonicotinamide) 1453-82-3 25mg NH2
0025 N
N
MM0845.03-
Impurity C (EP): Pyridine-4-carbonitrile (Isonicotinonitrile) 100-48-1 25mg
0025 N
MM1529.01- O
2-Isoniazid 1452-63-7 25mg N
0025
HN
N H2
Isopropyl Palmitate
O
2-Isopropylthioxanthone (2-ITX)
O
MM2585.00-
2-Isopropylthioxanthone (2-ITX) 5495-84-1 250mg
0250 S
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-322
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
Isoproturon
H
MM2503.02- N N
3-(2-Isopropylphenyl)-1,1-dimethylurea 70214-90-3 25mg
0025 O
H
MM2503.03- N N
3-(3-Isopropylphenyl)-1,1-dimethylurea 55304-10-4 25mg
0025 O
O
+
O N
H
O
MM0126.05- O
Impurity B (EP): Isosorbide 2-Nitrate 16106-20-0 25mg
0025
O
HO H
H OH
O
MM0502.00- Impurity C (EP): Isosorbide Mononitrate
16051-77-7 250mg O
0250 (Isosorbide 5-Nitrate) O
+ O H
N
O
H O
O
MM0126.02 Dimethyl Isosorbide 5306-85-4 100mg
O
H
O
H OH
O
MM0126.03 Isosorbide 652-67-5 500mg
O
HO H
Isosorbide Mononitrate
H OH
O
MM0502.00-
Isosorbide Mononitrate 16051-77-7 250mg O
0250 O H
+ O
N
O
O
+
N
Impurity C (EP): Isosorbide 2-Nitrate H O
O
O
MM0126.05 Related compound A (USP): 1,4:3,6-Dianhydro-D-glucitol 2- 16106-20-0 100mg
nitrate in lactose O
HO H
O
+
N
Impurity C (EP): Isosorbide 2-Nitrate H O
O
MM0126.05- O
Related compound A (USP): 1,4:3,6-Dianhydro-D-glucitol 2- 16106-20-0 25mg
0025 nitrate in lactose O
HO H
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-323
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
H OH
O
MM0126.03 Isosorbide 652-67-5 500mg
O
HO H
H O
MM0502.03- O
Isosorbide 2-Acetate 13042-39-2 25mg
0025
O
HO H
Isothipendyl Hydrochloride
N
N
MM1009.00 Isothipendyl Hydrochloride 1225-60-1 100mg S
N
HCl
N
MM1009.07- N,N,ß-Trimethyl-10H-pyrido[3,2-b][1,4]benzothiazine-10- N HCl
132962-42-6 25mg S
N
0025 ethanamine Hydrochloride (ß-Isothipendyl Hydrochloride)
MM0486.04- NH
1-Azaphenothiazine 261-96-1 25mg
0025 S
N
Isotretinoin
O
MM0143.15- O
trans- -Ionone 79-77-6 100mg
0100
Isoxepac
O
O
Isoxsuprine Hydrochloride
AND Enantiomer
OH
HO
Isradipine
H
N
O O
Itraconazole
AND Enantiomer
O Cl
N
MM0258.00- N
N
84625-61-6 1000mg Cl
Itraconazole N O
O
N
N
N
1000 N
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-324
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
N N
O
N
N N
O
N
2-(1H-1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-4-yl]-
Cl
O
N
N
N
MM0258.04 Cl
74855-91-7 100mg
methoxy]phenyl]piperazin-1-yl]phenyl]-2-propyl- N
N
O
O
N
N
2,4-dihydro-3H-1,2,4-triazol-3-one O
2-(1H-1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-4-yl]-
Cl
O
MM0258.04- N
N
N
Cl
74855-91-7 25mg
0025 methoxy]phenyl]piperazin-1-yl]phenyl]-2-propyl- N
N
O
O
N
N
2,4-dihydro-3H-1,2,4-triazol-3-one O
MM0258.05- 2-(1H-1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-4-yl]- N
N
N
O
Cl
N
89848-49-7 25mg
methoxy]phenyl]piperazin-1-yl]phenyl]-2-(1- N O N
N O N
0025 O
methylethyl)-2,4-dihydro-3H-1,2,4-triazol-3-one
AND Enantiomer
N N
O
N
dihydro-3H-1,2,4-triazol-3-one O
Cl Cl
O O
N
N
N
AND Enantiomer
N N
O
N
dihydro-3H-1,2,4-triazol-3-one O
Cl Cl
O O
N
N
N
O
N N OH
MM0145.05 1-Acetyl-4-(4-hydroxyphenyl)piperazine 67914-60-7 100mg
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-325
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
MM0145.05- O
N N OH
1-Acetyl-4-(4-hydroxyphenyl)piperazine 67914-60-7 25mg
0025
MM0258.10- 2,4-Dihydro-4-[4-[4-(4-methoxyphenyl)-1- HN
O
N N N O
74853-07-9 25mg
0025 piperazinyl]phenyl]-3H-1,2,4-triazol-3-one N
AND Enantiomer
Cl Cl
cis-2-(2,4-Dichlorophenyl)-2-(1H-1,2,4-triazol-1- O
O
MM0258.11
ylmethyl)-1,3-dioxolane-4-methanol Mesilate
67914-86-7 100mg S O
N
O O
N
N
AND Enantiomer
Cl Cl
MM0258.11- cis-2-(2,4-Dichlorophenyl)-2-(1H-1,2,4-triazol-1- O
O
ylmethyl)-1,3-dioxolane-4-methanol Mesilate
67914-86-7 25mg S O
N
O O
0025 N
N
N N
N O
4-[4-[4-(4-Hydroxyphenyl)piperazin-1-yl]phenyl]-2-[(1RS)-1-
MM0258.17 106461-41-0 100mg
methylpropyl]-2,4-dihydro-3H-1,2,4-triazol-3-one N
OH
N N
N O
MM0258.17- 4-[4-[4-(4-Hydroxyphenyl)piperazin-1-yl]phenyl]-2-[(1RS)-1-
106461-41-0 25mg
0025 methylpropyl]-2,4-dihydro-3H-1,2,4-triazol-3-one N
OH
Cl Cl
MM0145.09- [2-(Bromomethyl)-2-(2,4-dichlorophenyl)-1,3-dioxolan-4-yl] O
68751-57-5 100mg HO
0100 methanol O
Br
Ivabradine Hydrochloride
O
MM3982.10- O
1,3-Dihydro-7,8-dimethoxy-2H-3-benzazepin-2-one 73942-87-7 25mg O
0025 NH
O
MM3982.20-
3,4-Dimethoxybicyclo[4.2.0]octa-1,3,5-triene-7-carbonitrile 35202-54-1 25mg O
0025 N
Ivacaftor
H
N
H
MM3921.00- N
Ivacaftor 873054-44-5 250mg O O
0250
OH
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-326
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
Kaempferol
OH
HO O
Ketamine Hydrochloride
O
Cl
MM0144.00- NH
HCl
Ketamine Hydrochloride 1867-66-9 250mg
0250
O
OH Cl
MM0144.02- Impurity B (EP): (2RS)-2-(2-Chloro-
n/a 25mg
0025 phenyl)-2-hydroxycyclohexanone
O Cl
HO
Impurity C (EP): (2-Chlorophenyl)(1-
MM0144.03 90717-17-2 100mg
hydroxycyclopentyl)methanone
O
Cl
N H2
HCl
MM0144.06 Norketamine Hydrochloride 79499-59-5 100mg
O
Cl
MM0144.06- N H2
HCl
Norketamine Hydrochloride 79499-59-5 25mg
0025
O
Cl
MM0144.07- NH2
Dehydronorketamine Hydrochloride 1435934-26-1 25mg HCl
0025
O
Cl
NH
MM0144.09 N-Ethylnorketamine Hydrochloride n/a 100mg HCl
O
Cl
MM0144.09- NH
N-Ethylnorketamine Hydrochloride n/a 25mg HCl
0025
O
Cl
MM0144.10- NH
HCl
(R)-Ketamine Hydrochloride 33795-24-3 25mg
0025
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-327
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
O
HN
MM3713.01- HCl
4-(4-Methoxybenzoyl)piperidine Hydrochloride 25519-82-8 25mg
0025 O
Ketoconazole
AND Enantiomer
Cl Cl
O
MM0145.00-
Ketoconazole 65277-42-1 250mg N
O
O
N
N
O N
0250
O
AND Enantiomer
Cl
1,3-dioxolan-4-yl]methoxy]phenyl]piperazine
N
HN
O
AND Enantiomer
Cl
1,3-dioxolan-4-yl]methoxy]phenyl]piperazine
0025 N
HN
AND Enantiomer
Cl Cl
(1H-imidazol-1-ylmethyl)-1,3-dioxolan-4-yl]methyl
O
O S O
MM0145.06 134071-44-6 100mg N
4-Methylbenzenesulfonate N
AND Enantiomer
Cl Cl
(1H-imidazol-1-ylmethyl)-1,3-dioxolan-4-yl]methyl
O
O S O
134071-44-6 25mg N
0025 4-Methylbenzenesulfonate N
MM0145.05- O
0025
AND Enantiomer
Cl Cl
O
O
O N
MM0145.07 Ketoconazole N-Oxide 254912-65-7 100mg N
+
N
O N
Cl Cl
MM0145.09- [2-(Bromomethyl)-2-(2,4-dichlorophenyl)-1,3-dioxolan-4-yl] O
68751-57-5 100mg HO
0100 methanol O
Br
Ketoprofen
O
OH
MM0001.00 Ketoprofen 22071-15-4 500mg O
O
MM0001.03- OH
Impurity B (EP): (3-Benzoylphenyl)acetic Acid 22071-22-3 25mg O
0025
Impurity C (EP): 3-[(1RS)-1-Carboxyethyl]- O
benzoic Acid HO
OH
acid
Impurity C (EP): 3-[(1RS)-1-Carboxyethyl]- O
MM0001.07- benzoic Acid HO
OH
acid
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-328
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
O
MM0001.05- Impurity E (EP): (2RS)-2-(3-Benzoylphenyl)- N H2
59512-16-2 25mg
0025 propanamide O
benzophenone
Impurity F (EP): (2RS)-2-(3-Benzoylphenyl)- O
MM0001.04- propanenitrile
Related compound F (USP): 3-(1-Cyanoethyl)
42872-30-0 25mg N
0025
benzophenone
O
Impurity G (EP): 3-[(1RS)-1-Cyanoethyl]- HO
MM0001.20 5537-71-3 100mg
benzoic Acid N
O
MM0001.20- Impurity G (EP): 3-[(1RS)-1-Cyanoethyl]- HO
5537-71-3 25mg
0025 benzoic Acid N
O
MM0001.22-
Impurity H (EP): 3-(Cyanomethyl)benzoic Acid 5689-33-8 25mg HO
N
0025
O
O
Impurity J (EP): (2RS)-2-[3-(2,4-Dimethylbenzoyl)- OH
MM0001.23 1785759-59-2 50mg
phenyl]propanoic Acid O
O OH
O O
OH
2-[3-( -Hydroxybenzyl)phenyl]- OH
MM0001.18 59960-32-6 100mg
propanoic Acid O
OH
MM0001.18- 2-[3-( -Hydroxybenzyl)phenyl]- OH
59960-32-6 25mg
0025 propanoic Acid O
O
Ethyl 2-(3-Benzoylphenyl)propionate O
MM0001.19
(Ketoprofen Ethyl Ester)
60658-04-0 100mg O
O
O
MM0001.21 Isopropyl 2-(3-Benzoylphenyl)propionate 220662-26-0 100mg O
O O
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-329
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
O OH
O
(Mixture of Isomers)
MM0001.28 n/a 50mg O
OH
O
O
MM0001.31-
Methyl 2-Cyanomethylbenzoate 5597-04-6 25mg O
N
0025
O
Methyl 2-(3-Benzoylphenyl)propionate O
O
MM0001.32- Methyl 2-(3-Benzoylphenyl)propionate O
2-Ethylhexyl 2-(3-Benzoylphenyl)propionate O
O
O
O
O OH
Ketoprofen 1,3-Butylene Glycol Esters (Mixture of Regio- and
MM0001.34 n/a 100mg O
Stereoisomers) O OH
O OH
O
MM0001.35 Ketoprofen 2,3-Butylene Glycol Ester 94561-67-8 100mg O
O OH
O OH
O
Ketoprofen 1,2,3-Propanetriol Esters (Mixture of Regio- and
MM0001.36 n/a 50mg O
Stereoisomers) O
OH
O
OH
Ketoprofen Lysinate
O
OH
Ketorolac Trometamol
O
OH
pyrrolizin-1-one
Impurity E (EP): (1RS)-5-Benzoyl-N-[2-hydroxy-
1,1-bis(hydroxymethyl)ethyl]-2,3-dihydro-1H- OH
MM0851.07- pyrrolizine-1-carboxamide O
N
OH
(hydroxymethyl)propan-2-yl)-2,3-dihydro-1H-pyrrolizine-1-
carboxamide
O
Impurity H (EP): Methyl (1RS)-5-Benzoyl-2,3-dihydro-1H- O
MM0851.10 80965-09-9 100mg N
pyrrolizine-1-carboxylate (Ketorolac Methyl Ester) O
O
MM0851.10- Impurity H (EP): Methyl (1RS)-5-Benzoyl-2,3-dihydro-1H- O
80965-09-9 25mg N
0025 pyrrolizine-1-carboxylate (Ketorolac Methyl Ester) O
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-330
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
O
Impurity J (EP): Ethyl (1RS)-5-Benzoyl-2,3-dihydro-1H- O
MM0851.11 108061-03-6 100mg N
pyrrolizine-1-carboxylate (Ketorolac Ethyl Ester) O
O
MM0851.11- Impurity J (EP): Ethyl (1RS)-5-Benzoyl-2,3-dihydro-1H- O
108061-03-6 25mg N
O
MM0851.12 6-Benzoyl-2,3-dihydro-1H-pyrrolizin-1-one n/a 100mg
N
O
MM0851.12- O
6-Benzoyl-2,3-dihydro-1H-pyrrolizin-1-one n/a 25mg
0025 N
O
MM0851.14- O
Ketorolac Isopropyl Ester 66635-74-3 25mg N
0025 O
O OH
O
N
n/a 25mg O
0025 Stereoisomers) N
O OH
O
MM0851.16- O
Ketorolac 2,3-Butylene Glycol Ester n/a 25mg N
OH
0025 O
O
N
OH
MM0851.17- Ketorolac 1,2-Propylene Glycol Esters (Mixture of Regio- and O
n/a 25mg O
0025 Stereoisomers) OH
O
N
O
MM0851.19- Ethyl 5-Benzoyl-1-hydroxy-2,3-dihydropyrrolizine-1- O
OH
n/a 25mg N
0025 carboxylate O
O
MM0851.20- Isopropyl 5-Benzoyl-1-hydroxy-2,3-dihydropyrrolizine-1- O
n/a 25mg OH
N
0025 carboxylate O
O
OH
S N
S N
Impurity B (EP): (4RS)-10-Methoxy-4-(1-methyl-
MM0180.08 piperidin-4-yl)-4H-benzo[4,5]cyclohepta[1,2- 59743-88-3 100mg O OH
b]thiophen-4-ol
S N
O
Impurity D (EP): 4-[(aRaS)-1-Methylpiperidin-4- S N
+
ylidene]-4,9-dihydro-10H-benzo[4,5]cyclo-
MM0180.07 88456-70-6 100mg O
hepta[1,2-b]thiophen-10-one N-Oxide
(Ketotifen N-Oxide)
S N
Impurity G (EP): 4-(1-Methylpiperidin-4-ylidene)-4H-benzo
MM0180.05- O
[4,5]cyclohepta[1,2-b]thiophen-9,10-dione (9,10- 43076-16-0 25mg
0025
Dioxoketotifen) O
S NH
O
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-331
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
S
O
10-Methoxy-4H-benzo[4,5]cyclohepta[1,2- O
b]thiophen-4-one
MM0180.11 59743-84-9 100mg
S
O
MM0180.11- 10-Methoxy-4H-benzo[4,5]cyclohepta[1,2- O
b]thiophen-4-one
59743-84-9 25mg
0025
Labetalol Hydrochloride
OH
H
N
MM0438.00-
Labetalol Hydrochloride 32780-64-6 250mg HO
0250 HCl
O N H2
OH
H
MM0438.01- Impurity A (EP) as Hydrochloride: 2-Hydroxy-5-[1--[(1- N
2726492-68-6 25mg
0025 methyl-3-phenylpropyl)amino]-]benzoic Acid Hydrochloride HO
O OH
HCl
Lacidipine
H
N
O O
MM0407.00-
Lacidipine 103890-78-4 250mg O O
O
0250 O
H
N
Impurity A (BP): Ethyl Methyl (E)-4-{2-[2-(tert-Butoxy- O O
O
pyridine-3,5-dicarboxylate
H
N
O
0025 pyridine-3,5-dicarboxylate
N
3,5-dicarboxylate
N
O
0025 3,5-dicarboxylate
Lacosamide
O
MM3640.00- O
Lacosamide 175481-36-4 250mg N
H
N
0250 H
O
MM3640.07- H
Impurity G (EP): N-Benzylacetamide N
588-46-5 25mg
0025
O
Lactitol Monohydrate
HO
OH
OH
HO
HO OH
OH
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-332
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
OH
OH
HO
MM0654.00 Impurity C (EP): D-Mannitol (Mannitol) 69-65-8 250mg OH
OH
HO
OH
OH
HO
MM1492.00 Impurity E (EP): D-Glucitol (D-Sorbitol, Sorbitol) 50-70-4 250mg OH
OH
HO
Lactose Monohydrate
HO
HO O
O O OH H2O
MM1485.00 Lactose Monohydrate 5989-81-1 250mg HO
HO OH
HO OH
Lactulose
Mixed
O
OH
MM1562.00 Impurity D (EP): D-arabino-Hex-2-ulopyranose (D-Fructose) 57-48-7 250mg HO
&1
OH
HO OH
Lamivudine
NH2
MM0749.00- O N
Lamivudine 134678-17-4 250mg
0250
O
S
HO
MM0045.00- OH
Impurity C (EP): Salicylic Acid 69-72-7 250mg
0250
OH
NH2
NH2
Impurity B (EP) as single (R,R)-Enantiomer: 4-Amino-1-
MM0749.05- N
[(2R,5R)-2-(hydroxymethyl)-1,3-oxathiolan-5-yl]pyrimidin-2 71-30-7 25mg
0025
(1H)-one O N
H
HN
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-333
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
AND Enantiomer
NH2
N
MM0749.16-
rac-cis-Lamivudine ((2RS,5SR)-Lamivudine) 136891-12-8 25mg O N
0025 O
S
HO
Lamotrigine
N N H2
N
N
MM0922.00-
Lamotrigine 84057-84-1 250mg
0250 NH2
Cl
Cl
N N H2
Impurity A (EP): 3-Amino-6-(2,3-dichlorophenyl)- N
NH
1,2,4-triazin-5(4H)-one
MM0922.01
Related compound C (USP): 3-amino-6-(2,3-
252186-78-0 100mg O
Cl
dichlorophenyl)-1,2,4-triazin-5(4H)-one Cl
N N H2
Impurity A (EP): 3-Amino-6-(2,3-dichlorophenyl)- N
NH
MM0922.01- 1,2,4-triazin-5(4H)-one
Related compound C (USP): 3-amino-6-(2,3-
252186-78-0 25mg O
0025 Cl
dichlorophenyl)-1,2,4-triazin-5(4H)-one Cl
N N H2
N
NH2
Impurity C (EP): (2Z)-[2-(Diaminomethylidene)-
MM0922.03 94213-23-7 100mg N
diazanylidene](2,3-dichlorophenyl)acetonitrile Cl
Cl
N N H2
N
NH2
MM0922.03- Impurity C (EP): (2Z)-[2-(Diaminomethylidene)-
94213-23-7 25mg N
0025 diazanylidene](2,3-dichlorophenyl)acetonitrile Cl
Cl
H
N O
N
MM0922.06- 1,2,4-triazin-3-yl]-2,3-dichlorobenzamide N Cl
dichlorophenyl)-1,2,4-triazin-3-yl]-2,3-dichlorobenzamide Cl
N NH2
Cl N
Impurity G (EP): 6-(2,4-Dichlorophenyl)-1,2,4- N
MM0922.07 38943-76-9 50mg
triazine-3,5-diamine NH2
Cl
O
MM0922.09- Cl
2,5-Dichlorobenzoyl Cyanide 64985-85-9 25mg N
0025
Cl
O
MM0922.10-
2,4-Dichlorobenzoyl Cyanide 35022-43-6 25mg N
0025
Cl Cl
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-334
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
MM0922.28- N
3,4-Dichlorobenzoyl Cyanide 35022-44-7 25mg
0025 Cl
Cl
O
Cl
MM0922.29- N
3,5-Dichlorobenzoyl Cyanide 99567-74-5 25mg
0025
Cl
Lansoprazole
N F F
S
O
F F
F
MM0474.07 213476-12-1 100mg
sulphinyl]-1H-benzimidazole (Lansoprazole O
O
N
+
N-Oxide)
Impurity B (EP): 2-[[[3-Methyl-4-(2,2,2-trifluoro-
ethoxy)pyridin-2-yl]methyl]sulphonyl]-1H- NH F
N
Related compound A (USP): 2-([3-Methyl-4-(2,2,2-
trifluoroethoxy)-2-pyridyl]methylsulfonyl)benzimidazole
Impurity B (EP): 2-[[[3-Methyl-4-(2,2,2-trifluoro-
MM0474.01- ethoxy)pyridin-2-yl]methyl]sulphonyl]-1H- NH F
N
0025 Related compound A (USP): 2-([3-Methyl-4-(2,2,2-
trifluoroethoxy)-2-pyridyl]methylsulfonyl)benzimidazole
H
N
MM0474.03 Impurity D (EP): 1H-Benzimidazol-2-ol 615-16-7 100mg O
N
H
H
N
MM0474.03-
Impurity D (EP): 1H-Benzimidazol-2-ol 615-16-7 25mg O
0025 N
H
H
N
MM0474.05 Impurity E (EP): 1H-Benzimidazole-2-thiol 583-39-1 100mg SH
N
H
MM0474.05- N
Impurity E (EP): 1H-Benzimidazole-2-thiol 583-39-1 25mg SH
0025 N
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-335
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
O
MM0474.04-
4-Ethoxyacetophenone 1676-63-7 25mg
0025 O
NH F F
NH F F
MM0474.08-
Lansoprazole Sulphone N-Oxide 953787-54-7 25mg N
O
S
O N+
O
F
0025 O
F F
2-Chloromethyl-3-methyl-4-(2,2,2-trifluoro- Cl
O
F
HCl
ethoxy)pyridine Hydrochloride
MM0474.09 127337-60-4 100mg N
F F
MM0474.09- 2-Chloromethyl-3-methyl-4-(2,2,2-trifluoro- Cl
O
F
HCl
127337-60-4 25mg
0025 ethoxy)pyridine Hydrochloride N
NH F F
S
O
1-Methyl-12-thioxopyrido[1',2':3,4]imidazo- N
[1,2-a]benzimidazol-2(12H)-one
MM0474.13 1246819-06-6 100mg N
N
S
O
MM0474.13- 1-Methyl-12-thioxopyrido[1',2':3,4]imidazo- N
[1,2-a]benzimidazol-2(12H)-one
1246819-06-6 25mg N
0025 N
O
+
MM0474.14- N
2,3-Dimethyl-4-nitropyridine N-Oxide 37699-43-7 25mg O
+
0025 N
O
F
F
MM0474.15- O
HO F
[3-Methyl-4-(2,2,2-trifluoroethoxy)pyridin-2-yl]methanol 103577-66-8 25mg
0025 N
O
MM0877.16-
2-Etoxyacetophenone 2142-67-8 100mg
0100
O
Latanoprost
O
HO
MM3316.00 Latanoprost 130209-82-4 50mg
HO
OH
O
[(3aR,4R,5R,6aS)-4-[(E,3S)-3-Hydroxy-5-phenylpent-1-enyl]- O
MM3316.05- H H
0025 O
Phenylbenzoate
OH
O
(3aR,4R,5R,6aS)-4-[(E,3S)-3-Hydroxy-5-phenylpent-1-enyl]- H H
MM3316.06 856240-62-5 100mg
3,3a,4,5,6,6a-hexahydro-2H-cyclopenta[b]furan-2,5-diol OH
OH
OH
O
MM3316.06- (3aR,4R,5R,6aS)-4-[(E,3S)-3-Hydroxy-5-phenylpent-1-enyl]- H H
856240-62-5 25mg
0025 3,3a,4,5,6,6a-hexahydro-2H-cyclopenta[b]furan-2,5-diol OH
OH
Leachables
MM3900.02- O
Benzyl 2-Naphthyl Ether 613-62-7 100mg
0100
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-336
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
Leflunomide
N
H
O N
F F
methylisoxazole-4-carboxamide
Impurity C (EP): 5-Methyl-N-[3-(trifluoromethyl)- N
F F
MM0859.03- phenyl]isoxazole-4-carboxamide O H
N
F
Related compound C (USP): N-(3'-Trifluoromethylphenyl)-5-
61643-23-0 25mg
0025 O
methylisoxazole-4-carboxamide
N
Impurity D (EP): 5-Methylisoxazole-4-carboxylic O
OH
MM0859.04 42831-50-5 100mg
Acid
O
N
Impurity D (EP): 5-Methylisoxazole-4-carboxylic O
MM0859.04- OH
42831-50-5 25mg
0025 Acid
O
N
H
MM0859.05- Impurity E (EP): 3-Methyl-N-[4-(trifluoromethyl)- O
N
208401-20-1 25mg
0025 phenyl]isoxazole-4-carboxamide O F
F F
F
F
N F
Impurity F (EP): 5-Methyl-N-[2-(trifluoromethyl)- O H
N
MM0859.06 n/a 100mg
phenyl]isoxazole-4-carboxamide
O
F
F
N F
MM0859.06- Impurity F (EP): 5-Methyl-N-[2-(trifluoromethyl)- O H
N
n/a 25mg
0025 phenyl]isoxazole-4-carboxamide
O
N
MM0859.07- Impurity G (EP): 5-Methyl-N-(4-methylphenyl)- O H
N
724429-16-7 25mg
0025 isoxazole-4-carboxamide O
H
MM0859.08- Impurity H (EP): 2-Cyano-N-[4-(trifluoromethyl)- N
24522-30-3 25mg
0025 phenyl]acetamide O F
F F
Lenalidomide
O
MM3641.00-
Lenalidomide 191732-72-6 250mg N
N
O
0250 H
NH2 O
O
MM3641.01 Methyl 2-Methyl-3-nitrobenzoate 59382-59-1 100mg
+
N
O O
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-337
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
O
MM3641.01-
Methyl 2-Methyl-3-nitrobenzoate 59382-59-1 25mg
0025
+
N
O O
3-(4-Nitro-1,3-dihydro-1-oxo-2H-isoindol-2-yl)-2,6- N O
MM3641.02 827026-45-9 100mg N
H
piperidinedione (4-Nitro Analogue of Lenalidomide) N
+ O
O O
MM3641.02- 3-(4-Nitro-1,3-dihydro-1-oxo-2H-isoindol-2-yl)-2,6- N O
827026-45-9 25mg N
H
0025 piperidinedione (4-Nitro Analogue of Lenalidomide) N
+ O
O O
O
O O
O
MM3641.15-
Methyl 2-(Bromomethyl)-3-nitrobenzoate 98475-07-1 25mg Br
0025
+
N
O O
Br
MM3641.16- O
Methyl 2-(Bromomethyl)-6-nitrobenzoate 61940-21-4 25mg
0025 +
N O
O O
O
MM3641.20- O
Benzyl N-(2,6-Dioxo-3-piperidyl)carbamate 24666-55-5 25mg N O
H
0025 N
H
O
Lenvatinib Mesilate
O N
H 2N
MM3934.00- O O
Lenvatinib 417716-92-8 250mg O
0250 N N
H H
Cl
Lercanidipine Hydrochloride
H
N
O O
+O
N
O
H
N
dicarboxylate N
+O
H
N
0025 dicarboxylate N
+O
1,1-Dimethyl-2-[N-(3,3-diphenylpropyl)-N-methylamino]ethyl N
O O
N
MM3441.02 Methyl 2,6-Dimethyl-4-(3-nitrophenyl)pyridine-3,5- 887769-34-8 50mg O O
+O
N
dicarboxylate O
MM3441.04- O
O OH
MM0092.04- 1,4-Dihydro-2,6-dimethyl-4-(3-nitrophenyl)pyridine-3,5-
74936-72-4 25mg O O
0025 dicarboxylic Acid Methyl Ester
+O
N
O
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-338
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
H 2N
H 2N
MM0003.08- O
Methyl 3-Aminobut-2-enoate 14205-39-1 25mg
0025
O
MM3441.08- 2-Methyl-1-[N-methyl-N-(3,3-diphenylpropyl)amino]propan-2-
100442-33-9 100mg HO
N
0100 ol
H
N
O O
+ O
N
O
Letrozole
N N
MM1143.00-
Letrozole 112809-51-5 250mg N
0250 N
N
MM1143.02- dibenzonitrile
Related compound A (USP): 4,4'-(1H-1,3,4-triazol-1-
112809-52-6 25mg N
0025
ylmethylene)dibenzonitrile N N
N
MM1143.04-
4-(Bromomethyl)benzonitrile 17201-43-3 25mg
0025 Br
N
MM1143.05-
4-Fluorobenzonitrile 1194-02-1 25mg
0025
F
N N
N N
MM1143.09-
4,4'-Carbonyldibenzonitrile (4,4'-Dicyanobenzophenone) 32446-66-5 25mg
0025 O
N N
MM1143.12-
4,4'-Methylenedibenzonitrile 10466-37-2 25mg
0025
Br Br
MM1143.14-
4,4'-Dibromobenzophenone 3988-03-2 25mg
0025 O
N
MM1143.17-
4-Methylbenzonitrile 104-85-8 100mg
0100
N
MM0235.03 1H-1,2,4-Triazole 288-88-0 100mg HN
N
N
MM0235.03-
1H-1,2,4-Triazole 288-88-0 25mg HN
0025 N
Leucine
NH2
OH
MM1470.00 Leucine (L-Leucine) 61-90-5 250mg
O
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-339
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
Levamisole Hydrochloride
N S
Levetiracetam
O
MM1372.00- N
Levetiracetam 102767-28-2 250mg N H2
0250 O
O
N
MM1372.01 Impurity A (EP): (2RS)-2-(2-Oxopyrrolidin-1-yl)butanoic Acid 67118-31-4 100mg OH
O
O
MM1372.01- N
Impurity A (EP): (2RS)-2-(2-Oxopyrrolidin-1-yl)butanoic Acid 67118-31-4 25mg OH
0025 O
O
MM1372.02- N
Impurity B (EP): (2Z)-2-(2-Oxopyrrolidin-1-yl)but-2-enamide 358629-47-7 25mg N H2
0025 O
N
MM1372.03 Impurity C (EP): Pyridin-2-ol 72762-00-6 100mg
OH
MM1372.03- N
Impurity C (EP): Pyridin-2-ol 72762-00-6 25mg
0025 OH
O
MM1372.04- Impurity D (EP): (2R)-2-(2-Oxopyrrolidin-1-yl)butanamide N
103765-01-1 25mg N H2
0025 ((R)-Etiracetam) O
NH2
MM1372.10-
Impurity E (EP): (1R)-1-Phenylethan-1-amine 3886-69-9 100mg
0100
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-340
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
O
MM1372.07- H 2N
(S)-2-Aminobutanoic Acid 1492-24-6 100mg OH
0100
H
N O
MM0083.05 Pyrrolidin-2-one (2-Pyrrolidone) 616-45-5 100mg
O
MM0083.00- N
Piracetam 7491-74-9 250mg N H2
0250 O
N H2 O
H
MM1372.11- N
1867585-44-1 25mg NH2
(2R)-2-[(2R)-2-Aminobutanamido]butanamide
0025 O
Levocarnitine
MM0759.00- + O
Levocarnitine 541-15-1 250mg N
0250 OH O
(Crotonobetaine Hydrochloride)
Levocetirizine Dihydrochloride
O
Cl O
N OH
MM1035.00-
Levocetirizine Dihydrochloride 130018-87-0 250mg
N HCl
2
0250
Cl
NH
N
Cl
NH
N
MM1035.01-
(R)-1-[(4-Chlorophenyl)phenylmethyl]piperazine 300543-56-0 25mg
0025
Cl
N H2
MM1035.02-
(R)-(4-Chlorophenyl)phenylmethanamine 163837-57-8 100mg
0100
O
Cl O
N O
N
O O
S Cl
MM1035.10- N
N,N-Bis(2-chloroethyl)-p-toluenesulfonamide 42137-88-2 25mg
0025
Cl
Levodopa
O
OH
MM0262.00 Levodopa 59-92-7 500mg N H2
HO
OH
HO
N H2
MM0634.00- Impurity B (EP): (2S)-2-Amino-3-(4-hydroxyphenyl)propanoic OH
60-18-4 250mg
0250 Acid (Tyrosine) O
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-341
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
O
MM0262.01 1-(3,4-Dihydroxyphenyl)propan-2-one 2503-44-8 50mg HO
OH
OH
OH
OH
OH
MM0262.06-
4-Hydroxy-3-methoxymandelic Acid 55-10-7 25mg HO
O
0025
O
O
MM0262.09- O
3,4-Methylenedioxybenzaldehyde (Piperonal) 120-57-0 100mg
0100
O
O
MM0262.16-
N,N-Dimethyl-L-phenylalanine 17469-89-5 25mg OH
0025 N
O
MM0262.17- O
OH
(2S)-2-Amino-3-(3-methoxyphenyl)propanoic Acid 33879-32-2 25mg
0025 NH2
O
HCl
MM0262.18 Levodopa Methyl Ester Hydrochloride 1421-65-4 100mg N H2
HO
OH
MM0262.18- O
HCl
Levodopa Methyl Ester Hydrochloride 1421-65-4 25mg N H2
HO
0025 OH
O
MM0262.20 Levodopa Isopropyl Ester 110301-07-0 100mg NH2
HO
OH
MM0262.20- O
Levodopa Isopropyl Ester 110301-07-0 25mg NH2
HO
0025 OH
Levodropropizine
N OH
NH
Impurity B (EP) as Hydrochloride: 1-Phenyl- N HCl
MM1246.02 2210-93-7 100mg
piperazine Hydrochloride
NH
MM1246.02- Impurity B (EP) as Hydrochloride: 1-Phenyl- N HCl
2210-93-7 25mg
0025 piperazine Hydrochloride
O
+
N OH
O
+
N OH
MM1246.05-
Levodropropizine N-Oxide 152237-40-6 25mg N OH
0025
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-342
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
Levofloxacin Hemihydrate
N O
N N
117707-40-1 25mg F
OH
0025 Related compound A (USP): (S)-9-fluoro-3-methyl-10- O O
(piperazin-1-yl)-7-oxo-2,3-dihydro-7H-pyrido[1,2,3-de][1,4]
benzoxazine-6-carboxylic acid
O
Impurity C (EP): 4-[(3S)-6-Carboxy-9-fluoro-3-methyl-7-oxo- +
N O
MM0846.03- N N
2,3-dihydro-7H-pyrido[1,2,3-de][1,4]benzoxazin-10-yl]-1- 117678-38-3 25mg OH
0025 F
methylpiperazine 1-Oxide (Levofloxacin N-Oxide) O O
oxo-2,3-dihydro-7H-pyrido[1,2,3-de][1,4]benzoxazine-6-
carboxylic acid
Impurity G (EP) as Hydrochloride: (3S)-9-Fluoro-3-methyl-10-
[[2-(methylamino)ethyl]amino]-7-oxo-2,3-dihydro-7H-pyrido
O
H
MM0846.11- [1,2,3-de][1,4]benzoxazine-6-carboxylic Acid Hydrochloride N N
N HCl
H
1346603-62-0 25mg F
OH
methyl-10-[2-(methylamino)ethylamino]-7-oxo-7H-pyrido
[1,2,3-de][1,4]benzoxazine-6-carboxylic acid
Impurity H (EP): Ethyl (3S)-9-Fluoro-3-methyl-10-(4-
methylpiperazin-1-yl)-7-oxo-2,3-dihydro-7H-pyrido[1,2,3-de]
N O
177472-30-9 25mg F
O
0025 Related compound C (USP): (S)-ethyl 9-fluoro-2,3-dihydro-3- O O
methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7H-pyrido[1,2,3-de]-
1,4-benzoxazine-6-carboxylate
N O
N N
O O
N O
MM0846.06- N N
N O
N N
O O
N O
MM0846.07- N N
OH
N F
MM0846.13- (1S)-6,8-Difluoro-1-[2-hydroxy-1-methylethyl]-7-(4- N N
1036016-10-0 25mg OH
0025 methylpiperazin-1-yl)-4-oxoquinoline-3-carboxylic Acid F
O O
MM0846.14- (S)-9,10-Difluoro-2,3-dihydro-3-methyl-7-oxo-7H-pyrido[1,2,3- F N
106939-34-8 25mg O
0025 de]-1,4-benzoxazine-6-carboxylic Acid Ethyl Ester F
O O
Levomenthol
OH
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-343
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
Levomepromazine Hydrochloride
N N
MM0266.00 Levomepromazine Hydrochloride 1236-99-3 500mg S
HCl
Levomepromazine Maleate
O
N N OH
MM0019.00 Levomepromazine Maleate 7104-38-3 100mg S OH
O
O
NH
MM0019.02 Impurity A (EP): 2-Methoxyphenothiazine 1771-18-2 100mg S
MM0019.02- NH
Impurity A (EP): 2-Methoxyphenothiazine 1771-18-2 25mg S
0025
O
MM1439.00- OH
Maleic Acid 110-16-7 250mg
0250 OH
N N
MM0019.05 O-Desmethyllevomepromazine 81607-63-8 100mg S
OH
MM0019.05- N N
O-Desmethyllevomepromazine 81607-63-8 25mg S
0025
OH
N N
MM0019.07 N-Demethyllevomepromazine Hydrochloride 61733-92-4 100mg S
H HCl
MM0019.07- N N
N-Demethyllevomepromazine Hydrochloride 61733-92-4 25mg S
H HCl
0025
O
N N
MM0019.09 Levomepromazine Sulphone Hydrochloride 60119-90-6 100mg O S
HCl
O
O
MM0019.09- N N
Levomepromazine Sulphone Hydrochloride 60119-90-6 25mg O S
HCl
0025 O
O
+
MM0019.11- Levomepromazine Sulfone N-Oxide (Levomepromazine N N
2724689-26-1 25mg O S O
0025 N,S,S-Trioxide) O
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-344
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
Levonorgestrel
OH
H H
O
OH
OH
OH
OH
OH
55555-97-0 25mg
0025 pregn-4-en-20-yn-3-one (6 -Hydroxylevonorgestrel) O
H H
OH
OH
Ketolevonorgestrel) O
O
OH
OH
Impurity M (EP): 13-Ethyl-17-hydroxy-18,19-dinor-17 -
H H
MM0121.11 pregna-4,6-dien-20-yn-3-one ( 6-Levonorgestrel; 6,7- 51087-61-7 100mg
H H
Didehydrolevonorgestrel) O
OH
OH
MM0381.09- (1RS)-2-[(1,1-Dimethylethyl)amino]-1-[4-(benzyloxy)-3- H
N
(1RS)-2-[(1,1-Dimethylethyl)amino]-1-[4-hydroxy-3-
OH
H
(methoxymethyl)phenyl]ethanol N
MM0381.18-
Related compound C (USP): alpha-[(1,1-Dimethylethyl) 18910-70-8 25mg HO
0025
aminomethyl]-4-hydroxy-3-(methoxymethyl)- O
benzenemethanol
OH
H
N
MM3403.02- -[[(1,1-Dimethylethyl)amino]methyl]-2,2-dimethyl-4H-1,3-
54208-72-9 25mg O
0025 benzodioxin-6-methanol (Salbutamol Acetonide)
O
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-345
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
N -[[(1,1-Dimethylethyl)(phenylmethyl)amino]methyl]-2,2- OH
MM3403.03- N
e dimethyl-4H-1,3-benzodioxin-6-methanol (N- 1797114-57-8 25mg
0025 O
w Benzylsalbutamol Acetonide) O
Levosimendan
H
N N N
H
MM3946.00- O N
Levosimendan 141505-33-1 250mg N
0250 N
Levosulpiride
O O O
N
MM0941.00 Levosulpiride 23672-07-3 250mg H2 N
S
N
H
O
Levothyroxine Sodium
I
MM0694.00- I O
Levothyroxine Sodium
NH2
+
25416-65-3 100mg O Na H2 O
HO I
I O
0100
I
O
Impurity C (EP): [4-(4-Hydroxy-3-iodophenoxy)-3,5- O
MM0626.04 51-24-1 100mg HO I OH
diiodophenyl]acetic Acid (Triiodothyroacetic Acid) I
I
I O
Impurity D (EP): [4-(4-Hydroxy-3,5-diiodophenoxy)-3,5- O
MM0626.05 67-30-1 100mg HO I OH
diiodophenyl]acetic Acid (Tetraiodothyroacetic Acid) I
I
I O
MM0626.05- Impurity D (EP): [4-(4-Hydroxy-3,5-diiodophenoxy)-3,5- O
67-30-1 25mg HO I OH
0025 diiodophenyl]acetic Acid (Tetraiodothyroacetic Acid) I
NH2
iodophenyl]propanoic Acid 5817-39-0 25mg HO
OH
0025 (3,3',5'-Triiodo-L-Thyronine) I O
I O
I O
HN
MM0694.12 N-Acetyl-L-Thyroxine (N-Acetyllevothyroxine) 26041-51-0 100mg OH
HO I
I O
I O
I O
MM0694.12- HN
N-Acetyl-L-Thyroxine (N-Acetyllevothyroxine) 26041-51-0 25mg OH
HO I
0025 I O
I
HO
I
HO
MM0694.14-
3,5-Diiodo-4-hydroxybenzoic Acid 618-76-8 25mg OH
0025 I
O
I
I O
MM0694.16- 4-(4-Hydroxy-3-iodophenoxy)-3,5-diiodobenzoic Acid (3,3',5-
4618-45-5 25mg OH
HO I
0025 Triiodothyroformic Acid) O
I
I O
MM0694.17- 2-[4-(4-Hydroxy-3,5-diiodophenoxy)-3,5-diiodophenyl] O
176258-88-1 25mg HO I N H2
0025 acetamide (3,3',5,5'-Tetraiodothyroacetamide) I
I
MM0694.18- OH
2,6-Diiodophenol 28177-54-0 25mg
0025
I
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-346
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
0250 O
N H2
MM0102.02 Impurity A (EP): 2,6-Dimethylaniline 87-62-7 100mg
H
MM0102.08- Impurity C (EP): N-(2,6-Dimethylphenyl)- N
2198-53-0 25mg
0025 acetamide O
Hydrochloride)
Impurity D (EP) as Hydrochloride: N-(2,6-
MM0102.05- Dimethylphenyl)-2-(ethylamino)acetamide H
N
N HCl
7729-94-4 25mg H
0025 Hydrochloride (Monoethylglycinexylidide O
Hydrochloride)
Impurity E (EP) as Hydrochloride: 2,2'- H H
N N
acetamide] Hydrochloride
acetamide Hydrochloride
Impurity G (EP) as Hydrochloride: N-(2,6- H
MM0102.11- N
Dimethylphenyl)-2-[(1-methylethyl)amino]- 35891-87-3 25mg O
N
H
HCl
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-347
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
chloride
Impurity K (EP) as Hydrochloride: N-(2,6-Dimethyl- H
MM0102.14- N
phenyl)-2-(ethylmethylamino)acetamide Hydro- 50295-20-0 25mg O
N HCl
0025 chloride
H
N
N H2
MM0102.17 Glycinexylidide (2-Amino-N-(2,6-dimethylphenyl)acetamide) 18865-38-8 100mg
O
H
MM0102.17- N
N H2
Glycinexylidide (2-Amino-N-(2,6-dimethylphenyl)acetamide) 18865-38-8 25mg
0025 O
Cl
H
N
MM0102.18 2,2-Dichloro-N-(2,6-dimethylphenyl)acetamide 39084-88-3 100mg Cl
O
Cl
H
MM0102.18- N
2,2-Dichloro-N-(2,6-dimethylphenyl)acetamide 39084-88-3 25mg Cl
0025 O
Lidoflazine
F
Lidoflazine
N
N
MM3120.00 3416-26-0 50mg N O
Linagliptin
O
N N
N N
N
NH2
Lincomycin Hydrochloride
N OH
H
N
HCl H2O
O H O
MM0320.00 Lincomycin Hydrochloride Monohydrate 7179-49-9 250mg HO S
HO OH
Lindane
Cl
Cl Cl
Linezolid
O H
O N
O
N
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-348
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
(S)-5-(Aminomethyl)-3-(3-fluoro-4-morpholinophenyl) O
N
MM3300.01- oxazolidin-2-one (Desacetyllinezolid) O
168828-90-8 25mg F N
O
0025 Related compound C (USP): (S)-5-(aminomethyl)-3-(3-
NH2
fluoro-4-morpholinophenyl)oxazolidin-2-one
(R)-5-(Azidomethyl)-3-(3-fluoro-4-morpholinophenyl) O
N
MM3300.02- oxazolidin-2-one O
168828-84-0 25mg F N
O
0025 Related compound A (USP): (R)-5-(azidomethyl)-3-(3-fluoro- +
N N N
4-morpholinophenyl)oxazolidin-2-one
O
(S)-N-[[3-(3-Fluoro-4-morpholinophenyl)-2-oxooxazolidin-5-yl] N
O
MM3300.03- methyl]thioacetamide F N
O
216868-57-4 25mg
0025 Related compound B (USP): (S)-N-[3-(3-fluoro-4- H
N
morpholinophenyl)-2-oxooxazolidin-5-yl]methylthioacetamide S
O
+
N
O
O
F N
O
MM3300.04 Linezolid N-Oxide 189038-36-6 100mg
H
N
O
+
N
O
O
MM3300.04- F N
O
Linezolid N-Oxide 189038-36-6 25mg
0025 H
N
O
N
(5R)-3-(3-Fluoro-4-morpholinophenyl)-5-(hydroxymethyl) O
MM3300.05 168828-82-8 100mg F N
O
oxazolidin-2-one
OH
O
N
MM3300.05- (5R)-3-(3-Fluoro-4-morpholinophenyl)-5-(hydroxymethyl) O
168828-82-8 25mg F N
O
0025 oxazolidin-2-one
OH
(5R)-[3-(3-Fluoro-4-morpholinophenyl)-2-oxooxazolidin-5-yl] O
N
methyl Methanesulfonate O
MM3300.06- F N
O
Related compound D (USP): (R)-[3-(3-Fluoro-4- 174649-09-3 25mg
0025 O
O S
morpholinophenyl)-2-oxooxazolidin-5-yl]methyl
O
methanesulfonate
O
N
O
MM3300.07- F N
O
(R)-Linezolid 872992-20-6 25mg
0025 H
N
O
N
(5R)-5-(Chloromethyl)-3-[3-fluoro-4-(4-morpholinyl)phenyl]-2- O
MM3300.08 496031-57-3 100mg F N
O
oxazolidinone
Cl
O
N
MM3300.08- (5R)-5-(Chloromethyl)-3-[3-fluoro-4-(4-morpholinyl)phenyl]-2- O
496031-57-3 25mg F N
O
0025 oxazolidinone
Cl
O
N
O
2-[[(5S)-3-[3-Fluoro-4-(4-morpholinyl)phenyl]-2-oxo-5- F N
O O
MM3300.09 168828-89-5 100mg
oxazolidinyl]methyl]-1H-isoindole-1,3(2H)-dione N
O
N
O
MM3300.09- 2-[[(5S)-3-[3-Fluoro-4-(4-morpholinyl)phenyl]-2-oxo-5- F N
O O
168828-89-5 25mg
0025 oxazolidinyl]methyl]-1H-isoindole-1,3(2H)-dione N
O
N
O
MM3300.10- N
O
Desfluorolinezolid 556801-15-1 25mg
0025 H
N
O
N
MM3300.12- N-[(2S)-3-Amino-2-hydroxypropyl]-N-(3-fluoro-4- HCl
1391068-25-9 25mg F N NH2
0025 morpholinophenyl)acetamide Hydrochloride O
OH
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-349
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
O
N
O
MM3300.13- (5R)-[3-[3-Fluoro-4-(4-morpholinyl)phenyl]-2-oxo-5- F N
O
496031-56-2 25mg
0025 oxazolidinyl]methyl Acetate O
O
N
MM3300.16- N-[(2R)-3-(3-Fluoro-4-morpholinoanilino)-2-hydroxypropyl] F NH
333753-67-6 25mg OH
0025 acetamide
NH
O
N
O
MM3300.18 Benzyl 3-Fluoro-4-(4-morpholinyl)phenylcarbamate 168828-81-7 100mg F N O
H
O
N
MM3300.18- O
Benzyl 3-Fluoro-4-(4-morpholinyl)phenylcarbamate 168828-81-7 25mg F N O
0025 H
O
N
O
MM3300.19- (5S)-5-[[(1,1-Dimethylethyl)amino]methyl]-3-[3-fluoro-4-(4- F N O
1215006-08-8 25mg
0025 morpholinyl)phenyl]-2-oxazolidinone H
N
O
N
O
MM3300.20- N-(1,1-Dimethylethyl)-N-[[(5S)-3-[3-fluoro-4-(4-morpholinyl) F N O O
1215006-11-3 25mg
0025 phenyl]-2-oxo-5-oxazolidinyl]methyl]acetamide N
O
N
MM3300.24- N-(3-Phthalimido-2-(R)-hydroxypropyl)-3-fluoro-4-(4- O
874340-08-6 25mg F N
H
N
0025 OH
morpholinyl)aniline O
MM3300.23- O N N H2
3-Fluoro-4-(4-morpholinyl)aniline 93246-53-8 25mg
0025 F
Liothyronine Sodium
I
O
Liothyronine Sodium
N H2
MM0626.00 55-06-1 50mg O +
HO I Na
I O
O
MM0626.05 3,5-diiodophenyl]acetic Acid (Tetraiodothyroacetic 67-30-1 100mg HO I OH
Acid) I
O
3,5-diiodophenyl]acetic Acid (Tetraiodothyroacetic 67-30-1 25mg HO I OH
0025 Acid) I
I
O
N H2
MM0626.09 Liothyronine Methyl Ester 54914-53-3 100mg O
HO I
I O
I
O
MM0626.09- N H2
Liothyronine Methyl Ester 54914-53-3 25mg O
HO I
0025 I O
I
O
MM0626.10- N H2
I
O
MM0626.11- N H2
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-350
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
Lisdexamfetamine Dimesilate
N H2
MM1521.00- O H HCl
Lysine Hydrochloride (L-Lysine Hydrochloride) 657-27-2 250mg H2 N
0250 O
O
MM3626.01- O
HN O
N,N'-Bis(benzyloxycarbonyl)-L-lysine 405-39-0 25mg HO
0025 N O
H
O
O
2,5-Dioxopyrrolidin-1-yl (2S)-2,6-Bis(tert-
MM3626.03- O HN O O
O
butoxycarbonylamino)hexanoate (N,N'-Bis(tert- 30189-36-7 25mg N N O
H
O
0025 O
butoxycarbonyl)-L-lysine N-Succinimidyl Ester)
2,5-Dioxopyrrolidin-1-yl (2S)-2,6-Bis O
MM3626.04- O HN O O
(benzyloxycarbonylamino)hexanoate (N,N'-Bis 21160-83-8 25mg N
O
N O
0025 H
O
O
(benzyloxycarbonyl)-L-lysine N-Succinimidyl Ester)
Lisinopril Dihydrate
O
O OH
H
N
N
MM0598.00 Lisinopril Dihydrate 83915-83-7 100mg HO O
H2O
2 H 2N
O O
Impurity B (EP) as Hydrate: 4-Methylbenzene- S
OH H2O
MM0598.02 6192-52-5 100mg
sulphonic Acid Hydrate
Impurity C (EP): (2S)-2-[(3S,8aS)-3-(4-Aminobutyl)-
H
1,4-dioxohexahydropyrrolo[1,2-a]pyrazin-2(1H)- O
N
yl]-4-phenylbutanoic Acid (S,S,S-Diketopiperazine) N
O
MM0598.03
Related compound A (USP): (S)-2-(3S,8aS)-3-(4-
328385-86-0 25mg
HO O
aminobutyl)-1,4-dioxohexahydropyrrolo[1,2-alpha]pyrazin-2 H 2N
(1H)-yl-4-phenylbutanoic acid
H
O
Impurity D (EP): (2S)-2-[(3S,8aR)-3-(4-Aminobutyl)- N
N
MM0598.04 1,4-dioxohexahydropyrrolo[1,2-a]pyrazin-2(1H)- 219677-82-4 100mg O
H
O
Impurity D (EP): (2S)-2-[(3S,8aR)-3-(4-Aminobutyl)- N
MM0598.04- N
1,4-dioxohexahydropyrrolo[1,2-a]pyrazin-2(1H)- 219677-82-4 25mg O
O
N H
Impurity H (EP): (2S)-6-Amino-2-[[(1S)-1-carboxy-3- N
MM0598.07- OH
e 138247-43-5 25mg HO O
w
0025 phenylpropyl]amino]hexanoic Acid H 2N
MM0598.09- O
2-Oxo-4-phenylbutanoic Acid 710-11-2 25mg
0025
HO O
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-351
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
O
H
O N
OH
MM0598.10- O
N2-(Benzyloxycarbonyl)-N6-(tert-butoxycarbonyl)-L-lysine 2389-60-8 25mg H
0025 O N
Lobeline Hydrochloride
O
HCl
Lofepramine Hydrochloride
HCl Cl
Lofexidine Hydrochloride
Cl N
O
MM1898.00 Lofexidine Hydrochloride 21498-08-8 100mg N
H
HCl
Cl
Lomefloxacin Hydrochloride
HN F
HCl
N N
Lomustine
O
MM0923.01-
Impurity A (EP): 1,3-Bis(2-chloroethyl)urea 2214-72-4 25mg Cl
N N
Cl
0025 H H
2387-23-7 25mg
0025 Related compound C (USP): 1,3-Dicyclohexylurea N
H
N
H
Loperamide Hydrochloride
OH
N
N
Cl
OH
0025 diphenylbutanamide N
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-352
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
N O
OH Br
Impurity B (EP) as Bromide: 4-(4-Chlorophenyl)- +
N
MM0025.15 1,1-bis[4-(dimethylamino)-4-oxo-3,3-diphenyl- 2575516-63-9 100mg Cl
butyl]-4-hydroxypiperidinium Bromide N
N O
OH Br
Cl
OH
MM0025.04 Impurity C (EP): 4-(4-Chlorophenyl)piperidin-4-ol 39512-49-7 100mg
N
H
Cl
OH
MM0025.04-
Impurity C (EP): 4-(4-Chlorophenyl)piperidin-4-ol 39512-49-7 25mg
0025
N
H
OH
N
Impurity D (EP): 4-(4-Hydroxy-4-phenylpiperidin-
MM0025.05 37743-41-2 100mg
1-yl)-N,N-dimethyl-2,2-diphenylbutanamide
N
OH
N
MM0025.05- Impurity D (EP): 4-(4-Hydroxy-4-phenylpiperidin-
37743-41-2 25mg
0025 1-yl)-N,N-dimethyl-2,2-diphenylbutanamide
N
Cl
OH
Cl
OH
Cl
OH
O
MM0025.13 oxidopiperidin-1-yl]-N,N-dimethyl-2,2-diphenylbutanamide 109572-89-6 50mg
(Loperamide cis-N-Oxide) N
Cl
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-353
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
Cl
MM0025.07-
Ethyl Diphenylacetate 3468-99-3 25mg O
0025
O
O
MM0025.08-
, -Diphenyl- -butyrolactone 956-89-8 25mg O
0025
O
Dimethyl-(tetrahydro-3,3-diphenyl-2- Br
MM0025.10 +
furilidine)ammonium Bromide
37743-18-3 100mg N
O
MM0025.10- Dimethyl-(tetrahydro-3,3-diphenyl-2- Br
+
furilidine)ammonium Bromide
37743-18-3 25mg N
0025
Lopinavir
O
H
O
O
N
OH
N
H
O
MM1151.22- (2S)-3-Methyl-2-(2-oxotetrahydropyrimidin-1(2H)-yl)butanoic OH
192725-50-1 25mg N
0025 Acid O
N O
H
O
MM1151.23- O
2-(2,6-Dimethylphenoxy)acetic Acid 13335-71-2 25mg HO
0025
Loratadine
O
Cl
N O
MM0257.00-
Loratadine 79794-75-5 250mg
0250 N
N O
hydroxy-6,11-dihydro-5H-benzo[5,6]cyclo- OH
carboxylate
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-354
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
N O
MM0257.03- hydroxy-6,11-dihydro-5H-benzo[5,6]cyclo- OH
133284-74-9 25mg
0025 hepta[1,2-b]pyridin-11-yl]piperidine-1- N
carboxylate
Cl
Cl
O
Cl
ylidene)piperidine-1-carboxylate
Cl
O
Cl
Cl
Impurity D (EP): 8-Chloro-11-(piperidin-4-ylidene)-
MM0257.01- 6,11-dihydro-5H-benzo[5,6]cyclohepta-[1,2- NH
[1,2-b]pyridine
MM0257.05
Related compound B (USP): 8-Chloro-11-(1-
38092-89-6 100mg
N
methylpiperidin-4-ylidene)-6,11-dihydro-5H-benzo[5,6]
cyclohepta[1,2-b]pyridine
Impurity G (EP): 8-Chloro-11-(1-methylpiperidin-4- Cl
ylidene)-6,11-dihydro-5H-benzo[5,6]cyclohepta- N
MM0257.05- [1,2-b]pyridine
Related compound B (USP): 8-Chloro-11-(1-
38092-89-6 25mg
0025 N
methylpiperidin-4-ylidene)-6,11-dihydro-5H-benzo[5,6]
cyclohepta[1,2-b]pyridine
O
Cl
N
(11RS)-8-Chloro-11-hydroxy-11-(1-methylpiperidin- OH
Cl
N
MM0257.06- (11RS)-8-Chloro-11-hydroxy-11-(1-methylpiperidin- OH
O
Cl
N
MM0257.15-
N-Formyldesloratadine 117810-61-4 25mg
0025 N
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-355
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
NH
Deschlorodesloratadine Hydrochloride (6,11-Dihydro-11-
MM0257.19 (piperidin-4-ylidene)-5H-benzo[5,6]cyclohepta[1,2-b]pyridine n/a 100mg N
HCl
Hydrochloride)
NH
0025 Hydrochloride)
O
Cl
N O
MM0257.20- Ethyl 4-(2,8-Dichloro-5,6-dihydro-11H-benzo[5,6]cyclohepta
[1,2-b]pyridin-11-ylidene)piperidine-1-carboxylate
165739-64-0 25mg
0025 N
Cl
O
Cl
N O
O
Cl
N O
O
Cl
MM0257.24-
3-[2-(3-Chlorophenyl)ethyl]-2-pyridinecarboxamide 937642-75-6 25mg N
0025
O N H2
O
Cl
N O
O
MM0257.26-
Loratadine Epoxide 1189694-51-6 25mg
0025 N
Cl
N
N O
MM0257.25- N-Nitrosodesloratadine (8-Chloro-6,11-dihydro-11-(1-nitroso-
1246819-22-6 25mg
0025 4-piperidinylidene)-5H-benzo[5,6]cyclohepta[1,2-b]pyridin) N
Lorazepam
H O
N
OH
MM0071.00- N
Lorazepam 846-49-1 CS 250mg Cl
0250 Cl
N H2
Impurity A (EP): (2-Amino-5-chlorophenyl)(2-
MM0071.01- chlorophenyl)methanone Cl
O
MM0071.07- 2-oxo-2,3-dihydro-1H-1,4-benzodiazepin-3-yl O
N
Acetate (Lorazepam Acetate) 2848-96-6 CS 25mg Cl
O
0025 Related compound A (USP): 7-Chloro-5-(o-chlorophenyl)- Cl
1,3-dihydro-3-acetoxy-2H-1,4-benzodiazepin-2-one
H O
N
H O
N
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-356
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
H O
N
O
Impurity D (EP): (5RS)-7-Chloro-5-(2-chlorophenyl)- Cl N
MM0071.03 54699-91-1 100mg H
4,5-dihydro-1H-1,4-benzodiazepine-2,3-dione Cl
H O
N
O
MM0071.03- Impurity D (EP): (5RS)-7-Chloro-5-(2-chlorophenyl)- Cl N
54699-91-1 25mg H
0025 4,5-dihydro-1H-1,4-benzodiazepine-2,3-dione Cl
O
N
Impurity E (EP): 6-Chloro-4-(2-chlorophenyl)-
MM0071.02- quinazoline-2-carbaldehyde Cl
N
6-Chloro-4-(2-chlorophenyl)-2- N
OH
MM0071.04- quinazolinecarboxylic Acid Cl
N
quinazolinecarboxylic Acid
OH
N
6-Chloro-4-(2-chlorophenyl)-2-quinazoline-
MM0071.08- methanol Cl
N
H
N O
6-Chloro-4-(2-chlorophenyl)-2(1H)- Cl
N
quinazolinone
MM0071.09 23441-87-4 100mg
Cl
H
N O
MM0071.09- 6-Chloro-4-(2-chlorophenyl)-2(1H)- Cl
N
quinazolinone
23441-87-4 25mg
0025 Cl
Lormetazepam
O
N
OH
MM0072.00-
Lormetazepam 848-75-9 CS 250mg Cl N
0250 Cl
Losartan Potassium
OH
N N
N NH
N
Cl
MM0168.00 Losartan 114798-26-4 100mg N
OH
N N
+
N N K
N
OH
NH
MM0168.13- Impurity A (Pharmeuropa): (2-Butyl-4-chloro-1H- Cl
imidazol-5-yl)methanol
79047-41-9 25mg N
0025
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-357
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
N N
HN N
MM0168.14- Impurity B (EP): [2'-(1H-Tetrazol-5-yl)biphenyl- HO
160514-13-6 25mg
0025 4-yl]methanol
N N
Cl
Impurity C (EP): [2-Butyl-5-chloro-1-[[2'-(1H- N
HN N
imidazol-4-yl]methanol
O
5-carbaldehyde
N N
HN N
Impurity E (EP): 5-(4'-Methylbiphenyl-2-yl)-1H-
MM0168.05 120568-11-8 50mg
tetrazole
N N
HN N
MM0168.05- Impurity E (EP): 5-(4'-Methylbiphenyl-2-yl)-1H-
120568-11-8 25mg
0025 tetrazole
n/a 25mg N
0025 methyl]biphenyl-2-yl]-1H-tetrazole (Losartan
Isopropyl Ether)
MM0173.04-
Impurity G (EP) : Triphenylmethanol 76-84-6 25mg OH
0025
N
4-yl]methyl]-1H-imidazol-5-yl]methanol
N
0025 4-yl]methyl]-1H-imidazol-5-yl]methanol
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-358
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
0025 1-yl]methyl]biphenyl-2-yl]-1H-tetrazole N
O
tetrazol-5-yl)biphenyl-4-yl]methyl]-1H- HN
N N
N
MM0168.18- tetrazol-5-yl)biphenyl-4-yl]methyl]-1H- HN
N N
N
tetrazol-5-yl)biphenyl-4-yl]methyl]-1H- N
HN N
Cl
MM0168.10 imidazol-5-carbaldehyde 114798-36-6 100mg N
tetrazol-5-yl)biphenyl-4-yl]methyl]-1H- N
HN N
MM0168.10- Cl
imidazol-5-carbaldehyde 114798-36-6 25mg N
N NH
MM0168.06- tetrazol-5-yl]biphenyl-4-yl]methyl-4-chloro-
1H-imidazol-5-yl]methanol 230971-71-8 25mg OH
N
N N
N
N N
4-chloro-5-hydroxymethyl-1H-imidazol-1-yl)methyl]biphenyl-2-
yl-1H-tetrazol-1-yl)methyl]-4-chloro-1H-imidazol-1-ylmethyl)
biphenyl-2-yl]tetrazol, potassium salt
Impurity L (EP) as Potassium Salt: Potassium 5-[4'-[[2-Butyl-
4-chloro-5-[5-[4'-[[2-Butyl-4-chloro-5-(hydroxymethyl)-1H- +
N
imidazol-1-yl]methyl]biphenyl-2-yl]tetrazol-1-yl]methyl-1H- K N
N N
MM0168.32- imidazol-1-yl]methyl]biphenyl-2-yl]tetrazolide OH N N
N N
4-chloro-5-hydroxymethyl-1H-imidazol-1-yl)methyl]biphenyl-2- N
yl-1H-tetrazol-1-yl)methyl]-4-chloro-1H-imidazol-1-ylmethyl)
biphenyl-2-yl]tetrazol, potassium salt
Impurity M (EP): [2-Butyl-1-[[2'-[2-[[2-butyl-4-
chloro-1-[[2'-(1H-tetrazol-5-yl)biphenyl-4-
yl]methyl]-1H-imidazol-5-yl]methyl]-2H-
N N
N
N
H
MM0168.07- tetrazol-5-yl]biphenyl-4-yl]methyl]-4-chloro-
1H-imidazol-5-yl]methanol
N
OH
230971-72-9 25mg N
N
N
N Cl
N
4-chloro-5-hydroxymethyl-1H-imidazol-1-yl)methyl]biphenyl-2-
yl-2H-tetrazol-2-yl)methyl]-4-chloro-1H-imidazol-1-ylmethyl)
biphenyl-2-yl]tetrazol, potassium salt
Impurity M (EP) as Potassium Salt: Potassium 5-[4'-[[2-Butyl-
4-chloro-5-[5-[4'-[[2-butyl-4-chloro-5-(hydroxymethyl)-1H-
N N
+
K N
N
imidazol-1-yl]methyl]biphenyl-2-yl]tetrazol-2-yl]methyl-1H-
MM0168.33- imidazol-1-yl]methyl]biphenyl-2-yl]tetrazolide N
OH
212316-88-6 25mg N
N
N
N Cl
N
4-chloro-5-hydroxymethyl-1H-imidazol-1-yl)methyl]biphenyl-
2-yl-2H-tetrazol-2-yl)methyl]-4-chloro-1H-imidazol-1-ylmethyl)
biphenyl-2-yl]tetrazol, potassium salt
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-359
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
OH
O N N
2-Butyl-4-chloro-1-[[2'-(1H-tetrazol-5-yl)[1,1'-biphenyl]-4-yl] N
N NH
MM0168.01- Cl
methyl]-1H-imidazole-5-carboxylic Acid (Losartan Carboxylic 124750-92-1 25mg N
0025
Acid)
O
N N
HN N
MM0168.11- N
Losartan Butyl Ether n/a 25mg Cl
N
0025
O
N N
HN N
N
Cl
MM0168.12 Losartan Methyl Ether 114798-94-6 100mg N
O
N N
HN N
N
MM0168.12- Cl
Losartan Methyl Ether 114798-94-6 25mg N
0025
N N
HN N
N N
HN N
MM0168.21-
5-Phenyl-1H-tetrazole 18039-42-4 25mg
0025
OH
N
N
2-[4-[[2-Butyl-4-chloro-5-(hydroxymethyl)imidazol-1-yl]methyl] Cl
MM0168.22 114772-55-3 100mg N
phenyl]benzonitrile
OH
N
N
MM0168.22- 2-[4-[[2-Butyl-4-chloro-5-(hydroxymethyl)imidazol-1-yl]methyl] Cl
114772-55-3 25mg N
0025 phenyl]benzonitrile
N
Br
N
Br
MM0168.23-
2-(4-Bromomethylphenyl)benzonitrile 114772-54-2 25mg
0025
Cl N
MM0168.24- 3-[(4-Bromophenyl)methyl]-2-butyl-5-chloroimidazole-4- N
143722-29-6 25mg Br
0025 carbaldehyde
O
N N
HN N
MM0168.26- N
Cl
Losartan Ethyl Ether n/a 25mg N
0025
O N N
O N NH
MM0168.27- 2-Oxo-2-[[[2'-(1H-tetrazol-5-yl)[1,1'-biphenyl]-4-yl]methyl] O
N
H
914465-61-5 25mg
0025 amino]ethyl Pentanoate
O N N
HO N NH
MM0168.28- 2-Hydroxy-N-[[2'-(1H-tetrazol-5-yl)[1,1'-biphenyl]-4-yl]methyl] N
H
914465-63-7 25mg
0025 acetamide
O
N N
MM0168.31- 2-Butyl-4-chloro-1-[[2'-[2-(triphenylmethyl)-2H-tetrazol-5-yl] N N
Cl N
133910-00-6 25mg N
0025 [1,1'-biphenyl]-4-yl]methyl]-1H-Imidazole-5-carboxaldehyde
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-360
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
O
N
N
MM0168.38- 2-[4-[(2-Butyl-4-chloro-5-formylimidazol-1-yl)methyl]phenyl] Cl
124750-67-0 25mg N
0025 benzonitrile
5-[4'-[[2-Butyl-4-chloro-5-[[(triphenylmethyl)oxy]methyl]-1H-
O
MM0168.39- N N
N N
imidazol-1-yl]methyl]biphenyl-2-yl]-2-(triphenylmethyl) 1796930-34-1 25mg Cl
N
0025 N
tetrazole
N
MM0487.09A N O
N-Nitrosodimethylamine 0.2 mg/ml in Methanol 62-75-9 1ml
ME-00.20
N
MM0487.10A N O
N-Nitrosodiethylamine (NDEA) 0.1 mg/ml in Methanol 55-18-5 1ml
ME-00.10
Loteprednol Etabonate
Cl
O
O
HO O
MM3645.00 Loteprednol Etabonate 82034-46-6 250mg H
O
O
H H
O
Lovastatin
O
OH
MM0050.00 Lovastatin 75330-75-5 100mg H
O O
Hydroxy-6-oxotetrahydro-2H-pyran-2-yl]- O
(3R,5R)-7-[(1S,2S,6R,8S,8aR)-2,6- OH O
Na
+
Dimethyl-8-[[(2S)-2-methylbutanoyl]oxy]- H
OH
MM0050.01 75225-50-2 100mg O O
1,2,6,7,8,8a-hexahydronaphthalen-1-yl]-
3,5-dihydroxyheptanoic Acid Sodium Salt
(Lovastatin Hydroxy Acid Sodium Salt)
Impurity B (EP) as Sodium Salt: O
(3R,5R)-7-[(1S,2S,6R,8S,8aR)-2,6- OH O
Na
+
MM0050.01- Dimethyl-8-[[(2S)-2-methylbutanoyl]oxy]- H
OH
75225-50-2 25mg O O
0025 1,2,6,7,8,8a-hexahydronaphthalen-1-yl]-
3,5-dihydroxyheptanoic Acid Sodium Salt
(Lovastatin Hydroxy Acid Sodium Salt)
O
MM0050.03- Dimethyl-8-[2-[(2R)-6-oxo-3,6-dihydro-2H-
pyran-2-yl]ethyl]-1,2,3,7,8,8a-hexahydro- 109273-98-5 25mg H
O O
0025 naphthalen-1-yl (2S)-2-Methylbutanoate
(Dehydrolovastatin)
O
Lovastatin Diol Lactone ((4R,6R)-6-[2-[(1S,2S,6R,8S,8aR)- O
MM0158.14- 1,2,6,7,8,8a-Hexahydro-8-hydroxy-2,6-dimethyl-1- OH
H
79952-42-4 25mg OH
0025 naphthalenyl]ethyl]tetrahydro-4-hydroxy-2H-pyran-2-one)
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-361
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
Loxapine Succinate
N O
OH
MM1530.00 Loxapine Succinate 27833-64-3 250mg N
N
OH
Cl
O
O
N
3-Chloro-11-(4-methylpiperazin-1-yl)dibenzo[b,f][1,4]
oxazepine N
MM1530.01 3454-96-4 100mg N
Related compound A (USP): 3-Chloro-11-(4-
methylpiperazin-1-yl)dibenzo[b,f][1,4]oxazepine O
Cl
N
3-Chloro-11-(4-methylpiperazin-1-yl)dibenzo[b,f][1,4]
MM1530.01- oxazepine N
3454-96-4 25mg N
0025 Related compound A (USP): 3-Chloro-11-(4-
methylpiperazin-1-yl)dibenzo[b,f][1,4]oxazepine O
Cl
+O
N
N
MM1530.04 Loxapine N-Oxide 25967-34-4 100mg N
Cl
Loxoprofen Sodium
O
MM3940.00- O
Loxoprofen Sodium 80382-23-6 250mg O Na
+
0250
Lucanthone Hydrochloride
HCl
O
Lufenuron
F Cl
F O
MM3415.00- O O F
F F F F
Lufenuron 103055-07-8 250mg N
H
N
H
0250 Cl
F
Lurasidone Hydrochloride
H
H O
N S
Lynestrenol
OH
H H
MM1787.00 Lynestrenol 52-76-6 250mg
H H
Lysergide
O
N N
H
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-362
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
HO N
H
N
H
HO N
H
MM1346.03-
Lysergic Acid 82-58-6 25mg
0025
N
H
Lysine Clonixinate
O
OH O
H2 N
Cl
Lysine Hydrochloride
N H2
MM1521.00-
Lysine Hydrochloride (L-Lysine Hydrochloride) 657-27-2 250mg H2 N
O H HCl
0250 O
Macitentan
O O
S Br
N NH
H
MM3908.00-
Macitentan 441798-33-0 250mg N
N O
O N
0250 N
Br
Mafenide Acetate
O O
S O
Mafenide Hydrochloride
O O
S
MM3127.00 Mafenide Hydrochloride 138-37-4 100mg H 2N
N H2 HCl
NH2
Impurity D (EP): (2S)-2-Aminopentanedioic Acid (Glutamic HO OH
MM1333.00 56-86-0 250mg
Acid) O O
O
MM0567.05- HO
Impurity F (EP): Butanedioic Acid (Succinic Acid) 110-15-6 100mg OH
0100 O
NH2
MM0169.00- Impurity G (EP): (2S)-2,5-Diamino-5-oxopentanoic Acid (L- H 2N OH
56-85-9 250mg
0250 Glutamine) O O
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-363
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
MM0881.00-
Orotic Acid 65-86-1 250mg NH
0250
O OH
Magnesium Pidolate
NH2
Impurity A (EP): (2S)-2-Aminopentanedioic Acid (Glutamic HO OH
MM1333.00 56-86-0 250mg
Acid) O O
Maleic Acid
O
MM1439.00- OH
Maleic Acid 110-16-7 250mg
0250 OH
Malic Acid
O
HO
MM1332.00 Malic Acid 6915-15-7 250mg OH
O OH
O
MM0460.10- HO
Impurity A (EP): (E)-Butenedioic Acid (Fumaric Acid) 110-17-8 250mg OH
0250 O
MM1439.00- OH
Impurity B (EP): (Z)-Butenedioic Acid (Maleic Acid) 110-16-7 250mg
0250 OH
Maltitol
OH
HO OH
O
HO OH
HO
OH
Maltol
O
Maltose Monohydrate
OH
HO OH
H
O
O
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-364
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
Mandelic Acid
O
O
MM0792.06-
Methyl Mandelate 4358-87-6 25mg O
0025
OH
O
MM1376.05-
Isopropyl Mandelate 4118-51-8 25mg O
0025 OH
Mannitol
OH
OH
HO
MM0654.00 Mannitol 69-65-8 250mg OH
OH
HO
OH
OH
HO
MM1492.00 Impurity A (EP): D-Glucitol (D-Sorbitol) 50-70-4 250mg OH
OH
HO
Maprotiline Hydrochloride
N
MM0820.00 Maprotiline Hydrochloride 10347-81-6 250mg H HCl
Ethanoanthracen-9(10H)-yl)-N-[3-(9,10- N
MM0820.02 n/a 10mg
ethanoanthracen-9(10H)-yl)propyl]-N-
methylpropan-1-amine Hydrochloride
Impurity B (EP) as Hydrochloride: 3-(9,10- HCl
MM0820.02- Ethanoanthracen-9(10H)-yl)-N-[3-(9,10- N
n/a 25mg
0025 ethanoanthracen-9(10H)-yl)propyl]-N-
methylpropan-1-amine Hydrochloride
(Dehydromaprotiline Hydrochloride)
MM0820.04 38849-14-8 50mg
Related compound D (USP): 3-(9,10-dihydro-9,10-
ethanoanthracen-9-yl)-N-methylprop-2-en-1-amine
Impurity E (EP) as Hydrochloride: 3-(9,10-
N
MM0820.05 Ethanoanthracen-9(10H)-yl)-N,N- 23941-45-9 100mg HCl
dimethylpropan-1-amine Hydrochloride
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-365
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
Maraviroc
H H
F N
N
MM3904.00- F N
Maraviroc
H
N N
376348-65-1 250mg O
H
0250
Marbofloxacin
N O N
N N
Mebendazole
O
H
N O
benzoylbenzimidazole
Impurity B (EP): (2-Hydroxy-1H-benzimidazol-5- H
N
yl)phenylmethanone OH
N
Related compound B (USP): 5-benzoyl-1H-benzo[d]
MM0882.02 21472-33-3 50mg
O
imidazole-2(3H)-one
Impurity C (EP): (2-Amino-1-methyl-1H-benzimidazol-5-yl)
MM0882.03- phenylmethanone 66066-76-0 25mg
N
N H2
N
0025 Related compound C (USP): 2-Amino-5-benzoyl-1- O
methylbenzimidazole
Impurity D (EP): Methyl (5-Benzoyl-1-methyl-1H- O
benzimidazol-2-yl)carbamate N
N
H
O
methylbenzimidazol-2-ylcarbamate
Impurity E (EP): Ethyl (5-Benzoyl-1H-benzimidazol- O
H
MM0882.05- 2-yl)carbamate N
N
H
O
benzimidazol-2-yl)carbamate
Impurity F (EP): Methyl [5-(4-Methylbenzoyl)-1H- O
H
MM0882.06- benzimidazol-2-yl]carbamate N
N
H
O
benzimidazol-2-ylcarbamate
Mebeverine Hydrochloride
O
N
HCl
O
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-366
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
OH
MM0319.01 Impurity D (EP): 3,4-Dimethoxybenzoic Acid (Veratric Acid) 93-07-2 100mg
O
O
MM0319.01- OH
Impurity D (EP): 3,4-Dimethoxybenzoic Acid (Veratric Acid) 93-07-2 25mg
0025 O
O
O
MM0319.02-
4-Methoxyphenylacetone 100-06-1 25mg
0025
O
O
MM0487.18- N O
N-Nitroso-N-ethyl-4-aminobutyric Acid 54897-63-1 100mg N
0100 OH
Mebhydrolin Napadisilate
O
HO
N S O
O S
OH
O
2
O
+
N
MM1891.01-
Mebhydrolin N-Oxide 210408-26-7 25mg N
0025
Mebrofenin
O OH
H
N
Br O
O OH
H O
MM3594.01- N +
N
Mebrofenin N-Oxide n/a 25mg O OH
0025
Br O
Mechlorethamine Hydrochloride
Meclofenamate Sodium
O
+
O Na H 2O
MM3888.00- NH
Meclofenamate Sodium Monohydrate 67254-91-5 250mg Cl Cl
0250
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-367
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
Meclofenamic Acid
O
OH
Meclofenoxate Hydrochloride
O
O N
MM0044.00 Meclofenoxate Hydrochloride 3685-84-5 500mg O
HCl
Cl
O
O
MM0044.02 (4-Chlorophenoxy)acetic Acid 122-88-3 100mg OH
Cl
O
MM0044.02- O
(4-Chlorophenoxy)acetic Acid 122-88-3 25mg OH
0025 Cl
O
MM0044.05- O
O
(4-Chlorophenoxy)acetic Acid Ethyl Ester 14426-42-7 25mg
0025 Cl
O
MM0044.06- O
O
(4-Chlorophenoxy)acetic Acid Isopropyl Ester 41944-93-8 25mg
0025 Cl
0250 N
Cl
Cl
Cl
bis[4-[(4-chlorophenyl)phenylmethyl]piperazine] N
N
Cl
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-368
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
methyl]-piperazine Cl
346451-15-8 25mg N
0025 methyl]-piperazine Cl
Cl
NH
Impurity H (EP): 1-[(RS)-(4-Chlorophenyl)phenyl- N
MM0586.07- HN
N-(3-Methylbenzyl)piperazine Dihydrochloride 5321-61-9 25mg N
HCl
2
0025
Medazepam
Medrogestone
O
H
MM0869.00 Medrogestone 977-79-7 100mg
H H
O
Medronic Acid
O
MM3503.01 Impurity A (EP): Tris(1-methylethoxy)phosphane 116-17-6 100mg P
O O
O O O O
Impurity B (EP): Tetrakis(1-methylethyl) P P
MM3503.02 1660-95-3 100mg O O
Methylenediphosphonate
Medroxyprogesterone
O
OH
H
MM0635.00 Medroxyprogesterone 520-85-4 100mg H H
O
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-369
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
Medroxyprogesterone Acetate
O
O
MM0532.00- H O
Medroxyprogesterone Acetate 71-58-9 250mg H H
0250 O
H O
MM0532.01 dioxopregn-4-en-17-yl Acetate 984-47-4 100mg H H
(6 -Hydroxymedroxyprogesterone Acetate) O
OH
MM0532.01- H O
dioxopregn-4-en-17-yl Acetate 984-47-4 25mg H H
0025
(6 -Hydroxymedroxyprogesterone Acetate) O
OH
O
Impurity B (EP): 17-Hydroxy-6 -methylpregn-4- OH
ene-3,20-dione (Medroxyprogesterone) H
MM0635.00 520-85-4 100mg
Related compound B (USP): 17-Hydroxy-6alpha- H H
O
methylpregn-4-ene-3,20-dione
O
Acetate) O
0025 Acetate) O
dioxopregnan-17-yl acetate
O
O
Impurity G (EP): 6-Methyl-3,20-dioxopregna- H
O
MM0532.07 595-33-5 250mg
4,6-dien-17-yl Acetate (Megestrol Acetate) O
H H
302-23-8 25mg
0025 (Hydroxyprogesterone Acetate) H H
O
Medrylamine Maleate
O
O
O
Medrylamine Maleate
N OH
MM3123.00 60407-52-5 50mg OH
Mefenamic Acid
O
OH
MM0327.00-
Mefenamic Acid 61-68-7 250mg NH
0250
NH2
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-370
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
Cl
O
MM0217.14-
Impurity C (EP): 2-Chlorobenzoic Acid 118-91-2 25mg OH
0025
Cl
O
MM0278.01-
Impurity D (EP): Benzoic Acid 65-85-0 250mg OH
0250
O
MM0327.07-
Mefenamic Acid Methyl Ester 1222-42-0 25mg NH
0025
O
MM0327.08-
Mefenamic Acid Ethyl Ester 1226-33-1 25mg NH
0025
O
MM0327.09-
Mefenamic Acid Isopropyl Ester n/a 25mg NH
0025
O OH O
O O OH
Mefenamic Acid 1,3-Butylene Glycol Esters (Mixture of NH NH
MM0327.10 n/a 100mg
Isomers)
O
O
OH
MM0327.11 Mefenamic Acid 2,3-Butylene Glycol Ester 95093-55-3 100mg NH
O O
OH
O O
MM0327.12- Mefenamic Acid 1,2-Propylene Glycol Esters (Mixture of NH
OH
NH
n/a 25mg
0025 Isomers)
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-371
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
OH
O O
OH
O OH O
MM0327.13- Mefenamic Acid 1,2,3-Propanetriol Esters (Mixture of NH
OH
NH
n/a 25mg
0025 Isomers)
Mefloquine Hydrochloride
AND Enantiomer
F
F
F F F
N
F
MM1198.00 Mefloquine Hydrochloride 51773-92-3 250mg HCl
H
HO
H N
AND Enantiomer
Impurity C (EP) as Hydrochloride: (RS)-[2,8-Bis F
F
F F F
N
(trifluoromethyl)quinolin-4-yl][(2RS)-piperidin-2-yl]methanol F
MM1198.03 58560-52-4 100mg HCl
Hydrochloride (threo-Mefloquine Hydrochloride) H
HO
AND Enantiomer
Impurity C (EP) as Hydrochloride: (RS)-[2,8-Bis F
F
F F F
N
MM1198.03- (trifluoromethyl)quinolin-4-yl][(2RS)-piperidin-2-yl]methanol F
58560-52-4 25mg HCl
0025 Hydrochloride (threo-Mefloquine Hydrochloride) H
HO
F
F
F F F
N
MM1198.01 35853-41-9 100mg F
2,8-Bis(trifluoromethyl)-4-quinolinol
OH
F
F
F F F
MM1198.01- N
35853-41-9 25mg F
2,8-Bis(trifluoromethyl)-4-quinolinol
0025
OH
F
F
F F F
N
F
MM1198.02 2,8-Bis-(trifluoromethyl)-4-quinolinecarboxylic Acid 35853-50-0 100mg
O OH
F
F
F F F
N
MM1198.02- F
2,8-Bis-(trifluoromethyl)-4-quinolinecarboxylic Acid 35853-50-0 25mg
0025
O OH
AND Enantiomer
F F
N
F
MM1198.06- (1RS,3SR,8aSR)-1,3-Bis[2,8-bis(trifluoromethyl)-4-quinolyl]- H
F
H
O
n/a 25mg F
H
N
0025 3,5,6,7,8,8a-hexahydro-1H-oxazolo[3,4-a]pyridine
F
N
F F
F F F
Megestrol Acetate
O
O
H
MM0532.07 Megestrol Acetate 595-33-5 250mg H H
O
O
en-17-yl Acetate (Medroxyprogesterone 71-58-9 250mg H H
Acetate)
0250 O
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-372
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
O
Impurity D (EP): 6-Methylidene-3,20-dioxopregn-4-en-17-yl O
H
MM0532.05 Acetate (6-Methylene Hydroxyprogesterone Acetate) 32634-95-0 100mg O
H H
O
Related compound D (USP): 6-Methylene-3,20-dioxopregn-
O
Impurity D (EP): 6-Methylidene-3,20-dioxopregn-4-en-17-yl O
MM0532.05- H
Acetate (6-Methylene Hydroxyprogesterone Acetate) 32634-95-0 25mg O
H H
0025 O
Related compound D (USP): 6-Methylene-3,20-dioxopregn-
MM0532.09- O
Meglumine
H
N
OH
Melatonin
O
H
N
MM1373.00-
Melatonin 73-31-4 250mg O
0250
N
H
Methoxytryptamine) O
MM1373.01 608-07-1 100mg
Related compound A (USP): 2-(5-methoxy-1H-indol-3-yl) N
H
ethanamine
2-(5-Methoxy-1H-indol-3-yl)ethanamine (5- NH2
MM1373.01- Methoxytryptamine) O
608-07-1 25mg
0025 Related compound A (USP): 2-(5-methoxy-1H-indol-3-yl) N
H
ethanamine
Meloxicam
O O
S
N
MM0246.00- H
Meloxicam 71125-38-7 250mg N N
0250 OH O S
1,2-benzothiazine-3-carboxylate- 1,1-dioxide
Impurity A (EP): Ethyl 4-Hydroxy-2-methyl-
O O
1,2-benzothiazine-3-carboxylate- 1,1-dioxide
H 2N N
Impurity B (EP): 5-Methylthiazol-2-amine
MM0246.01
Related compound B (USP): 5-Methylthiazol-2-amine
7305-71-7 100mg S
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-373
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
H 2N N
MM0246.01- Impurity B (EP): 5-Methylthiazol-2-amine
Related compound B (USP): 5-Methylthiazol-2-amine
7305-71-7 25mg S
0025
O O
3-carboxamide 1,1-Dioxide OH O S
O O
benzothiazine-3-carboxamide 1,1-Dioxide OH O S
O O
Impurity E (EP): Methyl 4-Hydroxy-2-methyl- S
N
MM0084.02 2H-1,2-benzothiazine-3-carboxylate 1,1- 35511-15-0 100mg O
Dioxide OH O
O O
2H-1,2-benzothiazine-3-carboxylate-1,1-dioxide
Impurity F (EP): Isopropyl 4-Hydroxy-2-methyl-2H-
1,2-benzothiazine-3-carboxylate 1,1-Dioxide O O
S
MM0084.12- (1-Methylethyl 4-Hydroxy-2-methyl-2H-1,2- N
O
benzothiazine-3-carboxylate 1,1-Dioxide)
118854-48-1 25mg
0025
Related compound C (USP): Isopropyl 4-hydroxy-2-methyl- OH O
2H-1,2-benzothiazine-3-carboxylate-1,1-dioxide
O O
S
4-Hydroxy-2-methyl-2H-1,2-benzothiazine-3-carboxamide N
MM0084.09 24683-25-8 100mg NH2
1,1-Dioxide
OH O
O O
S
MM0084.09- 4-Hydroxy-2-methyl-2H-1,2-benzothiazine-3-carboxamide N
24683-25-8 25mg NH2
0025 1,1-Dioxide
OH O
O
O
S
1-Methylethyl (1,1-Dioxido-3-oxo-1,2-benzisothiazol-2(3H)-yl) N
MM0084.10 76508-37-7 100mg O
acetate O O
O
O
S
MM0084.10- 1-Methylethyl (1,1-Dioxido-3-oxo-1,2-benzisothiazol-2(3H)-yl) N
76508-37-7 25mg O
0025 acetate O O
O O
S
1-Methylethyl 4-Hydroxy-2H-1,2-benzothiazine-3-carboxylate NH
MM0084.11 76508-35-5 100mg O
1,1-Dioxide
OH O
O O
S
MM0084.11- 1-Methylethyl 4-Hydroxy-2H-1,2-benzothiazine-3-carboxylate NH
76508-35-5 25mg O
0025 1,1-Dioxide
OH O
O O
4-Methoxy-2-methyl-N-(5-methyl-1,3-thiazol-2-yl)-2H-1,2- S
N
MM0246.13- H
N N
benzothiazine-3-carboxamide 1,1-Dioxide (O- 1391051-96-9 25mg
0025 O O S
Methylmeloxicam; 4-Methoxymeloxicam)
O O
S
Methyl 4-Hydroxy-2H-1,2-benzothiazine-3-carboxylate 1,1- NH
MM0084.04 35511-14-9 100mg O
Dioxide
OH O
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-374
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
O O
S
MM0084.04- Methyl 4-Hydroxy-2H-1,2-benzothiazine-3-carboxylate 1,1- NH
35511-14-9 25mg O
0025 Dioxide
OH O
O
O
S
Methyl (1,1-Dioxido-3-oxo-1,2-benzisothiazol-2(3H)-yl) N
MM0084.07 6639-62-9 100mg O
acetate
O O
O
O
S
MM0084.07- Methyl (1,1-Dioxido-3-oxo-1,2-benzisothiazol-2(3H)-yl) N
6639-62-9 25mg O
0025 acetate
O O
O O
S
MM0084.27- OH
0025
2-Sulfobenzoic Acid 632-25-7 25mg OH
Melperone
O
O
MM0321.01- +
N
Melperone N-Oxide n/a 25mg O
0025 F
Melphalan
Cl
N HCl
Cl NH2
MM0824.02 Melphalan Hydrochloride 3223-07-2 100mg OH
H
MM0273.13 Impurity K (EP): N-Ethylethanamine (Diethylamine) 109-89-7 100mg N
Memantine Hydrochloride
NH2
OH
MM1045.01- 1-Hydroxy-3,5-dimethyladamantane
Related compound B (USP): 3,5-Dimethyladamantane-1-ol
707-37-9 25mg
0025
Cl
MM1045.04- 1-Chloro-3,5-dimethyladamantane
Related compound C (USP): 1-Chloro-3,5- 707-36-8 25mg
0025 dimethyladamantane
Br
1-Bromo-3,5-dimethyladamantane
MM1045.05-
Related compound D (USP): 1-Bromo-3,5- 941-37-7 25mg
0025
dimethyladamantane
MM1045.06- 1,3-Dimethyladamantane
702-79-4 25mg
0025 Related compound A (USP): 1,3-Dimethyladamantane
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-375
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
N-Formylmemantine NH
MM1045.07-
Related compound E (USP): N-3,5-Dimethyladamantan-1-yl 351329-88-9 25mg
0025
formamide
N H2
3-Methyladamantan-1-amine Hydrochloride
MM1045.08 (Desmethylmemantine Hydrochloride) 33103-93-4 100mg HCl
HN
MM1045.10-
N-Acetylmemantine 19982-07-1 25mg
0025
Menadione
O
Menthol Racemic
AND Enantiomer
OH
Mepacrine Hydrochloride
Cl
H
N
N
O
HCl
2
Cl
H O
N +
MM1695.02- N
N HCl
Mepacrine N-Oxide Dihydrochloride n/a 25mg 2
0025 O
Mepenzolate Bromide
+
N
O
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-376
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
Mephenesin
OH
O OH
MM0810.00 Mephenesin 59-47-2 500mg
Mephenesin Carbamate
OH
O O N H2
MM3135.00 Mephenesin Carbamate 533-06-2 50mg O
Mephentermine Hemisulphate
H
N O
Mepivacaine Hydrochloride
MM0368.00- H
0250 O
N H2
MM0102.02 Impurity A (EP): 2,6-Dimethylaniline 87-62-7 100mg
H
Impurity B (EP): (RS)-N-(2,6-Dimethylphenyl)piperidine-2- N
MM0368.08 15883-20-2 100mg N
carboxamide O
H
H
MM0368.08- Impurity B (EP): (RS)-N-(2,6-Dimethylphenyl)piperidine-2- N
15883-20-2 25mg N
0025 carboxamide O
H
H
Impurity C (EP): N-(2,6-Dimethylphenyl)- N
MM0368.03 39627-98-0 100mg N
pyridine-2-carboxamide O
H
MM0368.03- Impurity C (EP): N-(2,6-Dimethylphenyl)- N
39627-98-0 25mg N
0025 pyridine-2-carboxamide O
H
N
MM0368.06 Mepivacaine N-Oxide 1346597-75-8 100mg N
+
O
O
Meprednisone
O
OH
O OH
H H
O
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-377
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
Meprobamate
O O
H 2N O O NH2
MM0929.00 Meprobamate 57-53-4 CS 50mg
Meprotixol
N
OH
Meptazinol Hydrochloride
N
MM3132.00 Meptazinol Hydrochloride 59263-76-2 100mg OH
HCl
NH
Impurity A (EP): N-(4-Methoxybenzyl)pyridin-
MM0559.02 52818-63-0 100mg O N
2-amine
NH
MM0559.02- Impurity A (EP): N-(4-Methoxybenzyl)pyridin-
52818-63-0 25mg O N
0025 2-amine
NH2
NH2
MM0084.01-
Impurity C (EP): Pyridin-2-amine 504-29-0 25mg N
0025
+O O
N
MM0559.06- N
OH
0025 O
Mequinol
O
Mequitazine
AND Enantiomer
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-378
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
AND Enantiomer
+
N O
H
MM3131.01 Mequitazine N-Oxide n/a 100mg N
AND Enantiomer
N
H
MM3131.02 Mequitazine Sulfoxide 40765-34-2 100mg N
S
O
AND Enantiomer
N
MM3131.02- H
Mequitazine Sulfoxide 40765-34-2 25mg N
0025
S
O
AND Enantiomer
+ O
N
MM3131.04- H
Mequitazine Sulfoxide N-Oxide (Mequitazine N,S-Dioxide) 62705-13-9 25mg N
0025
S
O
AND Enantiomer
N O
+
MM3131.05- H
Mequitazine Sulfone N-Oxide (Mequitazine N,S,S-Trioxide) n/a 25mg N
0025
S
O O
Mercaptopurine
SH
H
MM1537.00- N
Mercaptopurine Monohydrate 6112-76-1 250mg N
H2 O
0250 N
N
N
HN
MM1047.01 Impurity A (EP): 1,7-Dihydro-6H-purin-6-one (Hypoxanthine) 68-94-0 100mg
N N
H
N
MM1047.01- HN
Impurity A (EP): 1,7-Dihydro-6H-purin-6-one (Hypoxanthine) 68-94-0 25mg
0025
N N
H
Meropenem Trihydrate
O
+
N
O
O
(4-Nitrophenyl)methyl (4R,5R,6S)-3- O
O
MM1327.03- N
O
Diphenoxyphosphoryloxy-6-[(1R)-1-hydroxyethyl]-4-methyl-7- 90776-59-3 25mg O
P
0025 HO H H O
O
oxo-1-azabicyclo[3.2.0]hept-2-ene-2-carboxylate
Mesalazine (Mesalamine)
O
MM0217.00- H 2N
Mesalazine 89-57-6 250mg OH
0250
OH
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-379
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
H 2N
H 2N
MM0042.01-
Impurity A (EP): 4-Aminophenol 123-30-8 25mg
0025 OH
MM0217.06-
Impurity C (EP): 2-Aminophenol 95-55-6 25mg OH
0025
NH2
OH
MM0217.07 Impurity D (EP): 3-Aminobenzoic Acid 99-05-8 100mg
NH2
MM0217.07- OH
Impurity D (EP): 3-Aminobenzoic Acid 99-05-8 25mg
0025
NH2
O
HO
MM0217.10 Impurity G (EP): 2,5-Dihydroxybenzoic Acid 490-79-9 100mg OH
OH
O
MM0217.10- HO
Impurity G (EP): 2,5-Dihydroxybenzoic Acid 490-79-9 25mg OH
0025
OH
MM0045.00- OH
Impurity H (EP): 2-Hydroxybenzoic Acid (Salicylic Acid) 69-72-7 250mg
0250
OH
O
Impurity I (EP): 2-Hydroxy-5-(phenyldiazenyl)benzoic N
N
OH
MM0217.12 3147-53-3 50mg
Acid (Phenylazosalicylic Acid) OH
H2 N
HCl
MM0093.17 Impurity K (EP) as Hydrochloride: Aniline Hydrochloride 142-04-1 100mg
Cl
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-380
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
MM0217.14-
Impurity L (EP): 2-Chlorobenzoic Acid 118-91-2 25mg OH
0025
Cl
O O
+
N
MM0217.15 Impurity M (EP): 2-Chloro-5-nitrobenzoic Acid 2516-96-3 100mg O OH
Cl
O O
+
MM0217.15- N
Impurity M (EP): 2-Chloro-5-nitrobenzoic Acid 2516-96-3 25mg O OH
0025 Cl
O O
+
Impurity N (EP): 2-Hydroxy-5-nitrobenzoic Acid O
N
OH
MM0217.16 96-97-9 100mg
(5-Nitrosalicylic Acid) OH
O O
+
MM0217.16- Impurity N (EP): 2-Hydroxy-5-nitrobenzoic Acid O
N
OH
96-97-9 25mg
0025 (5-Nitrosalicylic Acid) OH
H 2N
Impurity O (EP): 4-Aminobenzenesulfonic Acid (Sulfanilic OH
MM0227.04 121-57-3 100mg
Acid) S
O O
H 2N
MM0227.04- Impurity O (EP): 4-Aminobenzenesulfonic Acid (Sulfanilic OH
121-57-3 25mg
0025 Acid) S
O O
Salt Dihydrate)
O OH
OH
MM0217.02 5-Acetaminosalicylic Acid 51-59-2 100mg O
N
H
O OH
MM0217.02- OH
5-Acetaminosalicylic Acid 51-59-2 25mg O
0025
N
H
O
H 2N
MM0217.25 42753-75-3 100mg O
Mesalazine Methyl Ester
OH
O
MM0217.25- H 2N
42753-75-3 25mg O
Mesalazine Methyl Ester
0025 OH
O
H2 N
O
MM0217.26 Mesalazine Ethyl Ester 62773-65-3 100mg
OH
O
MM0217.26- H2 N
O
Mesalazine Ethyl Ester 62773-65-3 25mg
0025 OH
O
H2 N
O
MM0217.27 Mesalazine Isopropyl Ester 64240-87-5 50mg
OH
Mesna
O O
MM0345.00 Mesna 19767-45-4 250mg HS
S
O Na
+
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-381
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
NH2
MM0345.05- Impurity E (EP): 2-(4,6-Diamino-1,3,5-triazin-2-yl) N N O O
1391054-56-0 25mg
0025 sulfanylethanesulfonic Acid H 2N N S
S
OH
Mesoridazine Besilate
N N
MM0116.08- 10-[2-[(2RS)-1-Methylpiperidin-2-yl]ethyl]-2-(methylsulfinyl)- S
53926-89-9 25mg O
0025 10H-phenothiazine 5-Oxide (Mesoridazine 5-Sulfoxide)
S
O
N N
MM0116.11- 10-[2-[(2RS)-1-Methylpiperidin-2-yl]ethyl]-2-(methylsulfonyl)- O S
100574-22-9 25mg O
0025 10H-phenothiazine 5,5-Dioxide (Sulforidazine 5-Sulfone)
S
O O
+
N N
MM3617.02- Mesoridazine 5-Sulfoxide N-Oxide (Mesoridazine N,S5- S O
n/a 25mg O
0025 Dioxide)
S
O
Mesterolone
OH
H
MM0495.00 Mesterolone 1424-00-6 100mg H H
O
H
Mestranol
OH
H
MM1698.00 Mestranol 72-33-3 250mg H H
O
Metacresol
OH
Metacycline Hydrochloride
OH O OH O O
OH
N H2
O
Impurity A (EP): 4-Formylamino-1,5-dimethyl- H
N O
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-382
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
O
Impurity B (EP): 4-Amino-1,5-dimethyl-2-
MM0052.04 phenyl-1,2-dihydro-3H-pyrazol-3-one 83-07-8 100mg N
N H2
N
(Ampyrone)
O
MM0052.04- Impurity B (EP): 4-Amino-1,5-dimethyl-2-
phenyl-1,2-dihydro-3H-pyrazol-3-one 83-07-8 25mg N
N H2
N
0025 (Ampyrone)
(4-Methylaminophenazone Hydrochloride)
Impurity C (EP) as Hydrochloride: O H
N
MM0052.10- 4-Methylamino-1,5-dimethyl-2-phenyl-1,2- N
856307-27-2 25mg HCl
0025 dihydro-3H-pyrazol-3-one Hydrochloride N
(4-Methylaminophenazone Hydrochloride)
O
Impurity D (EP): 4-Dimethylamino-1,5-dimethyl- N
O
MM0052.11 phenyl-2,3-dihydro-1H-pyrazol-4-yl)amino]methanesulfonic 129-89-5 100mg N
N
O
phenyl-2,3-dihydro-1H-pyrazol-4-yl)amino]methanesulfonic 129-89-5 25mg N
N
0025 Acid Sodium Salt (4-N-Desmethylmetamizole Sodium Salt)
O H
N O
O H
N O
MM0052.01-
4-Acetylaminophenazone 83-15-8 25mg N
N
0025
O
MM0052.50- N
4-Benzylideneaminoantipyrine 83-17-0 25mg N
N
0025
Metapramine Fumarate
MM3977.01-
N-Methyliminostilbene (N-Methyl-2,2'-iminostilbene) 52249-32-8 25mg N
0025
Metaraminol Bitartrate
OH O OH
N H2
HO
OH O
OH
Metaxalone
H
N
O
MM3650.00- O
Metaxalone 1665-48-1 250mg O
0250
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-383
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
Metformin Hydrochloride
NH NH
H
Impurity A (EP): Cyanoguanidine H 2N N
MM0056.01
Related compound A (USP): 1-Cyanoguanidine
461-58-5 100mg N
NH
H
MM0056.01- Impurity A (EP): Cyanoguanidine H 2N N
Related compound A (USP): 1-Cyanoguanidine
461-58-5 25mg N
0025 NH
N H2
N H2
H 2N N NH2
H 2N N NH2
MM0056.04- Impurity D (EP): 1,3,5-Triazine-2,4,6-triamine N N
108-78-1 25mg
0025 (Melamine)
NH2
Methacholine Chloride
O
Methadone Hydrochloride
N
MM0531.00-
Methadone Hydrochloride 1095-90-5 CS 250mg HCl
0250 O
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-384
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
N
Impurity B (EP): (4RS)-4-(Dimethylamino)-2,2-
diphenylpentanenitrile (Didiavalo; Premethadone; Methadone
MM0531.09 125-79-1 CS 100mg
Nitrile) N
Related compound B (USP)
N
Impurity B (EP): (4RS)-4-(Dimethylamino)-2,2-
MM0531.09- diphenylpentanenitrile (Didiavalo; Premethadone; Methadone
125-79-1 CS 25mg
0025 Nitrile) N
Related compound B (USP)
N
Impurity C (EP) as Hydrochloride: (3RS)-4-(Dimethyl-
amino)-3-methyl-2,2-diphenylbutanenitrile Hydro- HCl
MM0531.04
chloride (Isodidiavalo Hydrochloride)
63867-26-5 50mg
N
MM0531.06-
Impurity E (EP): Diphenylacetonitrile 86-29-3 25mg
0025
MM0531.13- HCl
N,N,2-Trimethyl-3,3-diphenylpropan-1-amine Hydrochloride 63905-14-6 25mg
0025
Methamphetamine Hydrochloride
H
N
MM0964.00 Methamphetamine Hydrochloride 51-57-0 CS 100mg HCl
H
N
MM0964.03 rac-Methamphetamine Hydrochloride 300-42-5 CS 100mg HCl
H
MM0964.03- N
rac-Methamphetamine Hydrochloride 300-42-5 CS 25mg HCl
0025
Methapyrilene Hydrochloride
S
HCl
MM1680.01-
Methapyrilene N-Oxide 78761-79-2 25mg N N +
0025 N
O
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-385
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
Methaqualone Hydrochloride
N
N
MM1356.00 Methaqualone 72-44-6 CS 100mg
O
N
MM1356.02 Etaqualone (3-(2-Ethylphenyl)-2-methyl--one) 7432-25-9 100mg
O
MM1356.02- N
Etaqualone (3-(2-Ethylphenyl)-2-methyl--one) 7432-25-9 25mg
0025 O
Metharbital
H
O N O
Methenamine
N
O
MM1998.01- N+
Methenamine N-Oxide 62190-92-5 25mg
0025 N N
N
Methenolone
OH
H
MM1374.00 Methenolone 153-00-4 100mg H H
O
H
Methenolone Acetate
O
H H
O
H
OH
H
MM1374.00 Methenolone 153-00-4 100mg H H
O
H
Methenolone Enantate
O
H
O
H
OH
H
MM1374.00 Methenolone 153-00-4 100mg H H
O
H
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-386
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
Methionine
NH2
MM0358.00- OH
Methionine (L-Methionine) 63-68-3 250mg S
0250 O
NH2
Impurity A (EP): (2S)-2-Amino-4-[(RS)-methylsulfinyl] OH
MM0358.05 3226-65-1 100mg S
butanoic Acid (L-Methionine Sulfoxide) O O
NH2
MM0358.05- Impurity A (EP): (2S)-2-Amino-4-[(RS)-methylsulfinyl] OH
3226-65-1 25mg S
0025 butanoic Acid (L-Methionine Sulfoxide) O O
NH2
Impurity B (EP): (2S)-2-Amino-4-(methylsulfonyl)butanoic OH
MM0358.06 7314-32-1 100mg S
Acid (L-Methionine Sulfone) O O O
NH2
MM0358.06- Impurity B (EP): (2S)-2-Amino-4-(methylsulfonyl)butanoic OH
7314-32-1 25mg S
0025 Acid (L-Methionine Sulfone) O O O
DL-Methionine (Racemethionine)
NH2
MM0879.00- OH
DL-Methionine (Racemethionine) 59-51-8 250mg S
0250 O
Methocarbamol
OH
O O NH2
MM1061.00 Methocarbamol 532-03-6 250mg O
O
O
MM0354.09- O
4-[(2-Methoxyphenoxy)methyl]-1,3-dioxolan-2-one 2049-21-0 25mg O
0025
O
Methohexital
O N O
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-387
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
Methomyl
O
N
MM2523.00 Methomyl 16752-77-5 250mg O N
H
S
Methotrexate
O OH
O
OH
O
H 2N N N
NH2
Impurity A (EP) as Hydrochloride: (2,4-Diaminopteridin- N
N
OH HCl
MM0040.08 73978-41-3 100mg
6-yl)methanol Hydrochloride H 2N N N
NH2
MM0040.08- Impurity A (EP) as Hydrochloride: (2,4-Diaminopteridin- N
N
OH HCl
73978-41-3 25mg
0025 6-yl)methanol Hydrochloride H 2N N N
Aminopterin)
N H2 N
H
N O
MM0040.05 54-62-6 100mg N N
H
OH
6-yl)methylamino]benzamidopentanedioic acid
Impurity B (EP): (2S)-2-[[4-[[(2,4-Diaminopteridin-6-yl)methyl]
MM0040.05- amino]benzoyl]amino]pentanedioic Acid (4-Aminofolic Acid, O
O OH
Aminopterin)
N H2 N
H
N O
54-62-6 25mg N N
H
OH
0025 Related compound B (USP): (S)-2-4-[(2,4-diaminopteridin- H 2N N N
6-yl)methylamino]benzamidopentanedioic acid
Impurity C (EP): (2S)-2-[[4-[[(2-Amino-4-oxo-1,4-
dihydropteridin-6-yl)methyl]methylamino]benzoyl]amino] O
O OH
dihydropteridin-6-yl)methyl](methyl)aminobenzamido)
pentanedioic acid
O
Impurity E (EP): 2,4-Diamino-N10-methylpteroic Acid (APA)
MM0040.02- NH2 OH
N
Related compound E (USP): 4-[(2,4-Diaminopteridin-6-yl) 19741-14-1 25mg N N
0025 H2 N N N
methyl](methyl)aminobenzoic acid
O
Impurity G (EP) as Hydrochloride: (2S)-2-[[4-[[4-[[(2,4- NH2 N
MM0040.33- N
N
N
O OH
HCl
Diaminopteridin-6-yl)methyl]methylamino]benzoyl] n/a 25mg H 2N N N
O N
OH
0025 H
O
MM0040.25- N H2 N
H
N O
yl)methyl]methylamino]benzoyl]amino]pentanedioate 34378-65-9 25mg N N
O
0025 H 2N N N
O O
N
MM0621.09- N
6-Formylpterin 712-30-1 25mg
0025 H 2N N N
H
O O
N O
MM0040.13- NH2 N
H
N O
e Methotrexate Diethyl Ester 43170-88-3 25mg N N
O
H2 N N N
w
0025
NH2
MM0040.16- NH2 O O
N
2,4,5,6-Tetraaminopyrimidine Sulfate 5392-28-9 25mg S
HO OH
0025 H 2N N N H2
NH2
HO OH
MM1333.00 Glutamic Acid (L-Glutamic Acid) 56-86-0 250mg
O O
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-388
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
Methoxsalen
O
O O
MM0555.00 Methoxsalen 298-81-7 500mg O
Methoxyphenamine Hydrochloride
H
N
Methsuximide
O
N
MM3137.00 Methsuximide 77-41-8 100mg
O
Methyl Nicotinate
O
O
MM0553.00-
Impurity A (EP): Nicotinic Acid 59-67-6 250mg N OH
0250
Methyl Parahydroxybenzoate
O
MM0431.00- O
Methyl Parahydroxybenzoate 99-76-3 250mg
0250 HO
O
MM0045.01-
Impurity A (EP): 4-Hydroxybenzoic Acid 99-96-7 250mg OH
0250
HO
O
MM0498.00- Impurity B (EP): Ethyl 4-Hydroxybenzoate (Ethyl O
120-47-8 250mg
0250 Parahydroxybenzoate) HO
O
MM0432.00- Impurity C (EP): Propyl 4-Hydroxybenzoate O
94-13-3 250mg
0250 (Propyl Parahydroxybenzoate) HO
O
Impurity D (EP): Butyl 4-Hydroxybenzoate O
MM0496.00 94-26-8 500mg
(Butyl Parahydroxybenzoate) HO
O
MM0431.01 Sodium Methyl Parahydroxybenzoate 5026-62-0 500mg
+ O
Na
Methyl Salicylate
O
OH
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-389
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
OH
MM0045.11 Impurity B (EP): Phenol 108-95-2 100mg
O
MM0431.00- Impurity C (EP): Methyl 4-Hydroxybenzoate (Methyl O
99-76-3 250mg
0250 Parahydroxybenzoate)
HO
MM1063.01 O
Impurity D (EP): Methyl 4-Methoxybenzoate 121-98-2 100mg
O
O
MM1063.01- O
Impurity D (EP): Methyl 4-Methoxybenzoate 121-98-2 25mg
0025 O
OH
Methylbenzethonium Chloride
+
O N
Methylchloroisothiazolinone
Cl
S
MM0877.06- Methylchloroisothiazolinone (N-Methyl-5- N
26172-55-4 100mg
0100 chloroisothiazolone; 5-Chloro-2-methyl-4-isothiazolin-3-one)
O
Cl
S
MM3820.01- N
4,5-Dichloro-2-methylisothiazol-3-one 26542-23-4 25mg
0025 Cl
O
Methyldopa
O
OH
OH
2
Methyl (2S)-2-Amino-3-(3,4-dihydroxyphenyl)-2- O
MM1501.22- O
methylpropanoate Hydrochloride (Methyldopa Methyl Ester 115054-62-1 25mg H 2N HCl
HO
0025 OH
Hydrochloride)
Methylergometrine Maleate
O
HO N
Impurity A (EP): (6aR,9R)-7-Methyl-4,6,6a,7,8,9- H
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-390
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
HO N
Methylphenidate Hydrochloride
AND Enantiomer
O O
MM1031.00-
Methylphenidate Hydrochloride 23655-65-4 CS 250mg H
N
HCl
0250 H
AND Enantiomer
O NH2
MM1031.05- Impurity C (EP): (2RS)-2-Phenyl-2-[(2RS)-piperidin-2-yl] H
50288-62-5 25mg N
H
0025 acetamide
AND Enantiomer
Impurity E (EP) as Hydrochloride: Ethyl (2RS)-Phenyl[(2RS)- O O
H HCl
MM1031.09 piperidin-2-yl]acetate Hydrochloride (Ethylphenidate 19716-79-1 CS 100mg N
H
Hydrochloride)
AND Enantiomer
Impurity E (EP) as Hydrochloride: Ethyl (2RS)-Phenyl[(2RS)- O O
MM1031.09- H HCl
piperidin-2-yl]acetate Hydrochloride (Ethylphenidate 19716-79-1 CS 25mg N
0025 H
Hydrochloride)
O NH2
N
MM1031.08 Impurity F (EP): (2RS)-2-Phenyl-2-(pyridin-2-yl)acetamide 7251-52-7 100mg
O NH2
MM1031.08- N
Impurity F (EP): (2RS)-2-Phenyl-2-(pyridin-2-yl)acetamide 7251-52-7 25mg
0025
O OH
Ritalinic Acid H
N
MM1031.04 Related compound A (USP): alpha-Phenyl-2- 19395-41-6 100mg
piperidineacetic Acid
O OH
Ritalinic Acid H
MM1031.04- N
Related compound A (USP): alpha-Phenyl-2- 19395-41-6 25mg
0025 piperidineacetic Acid
O OH
Ritalinic Acid Hydrochloride H
N HCl
MM1031.11 Related compound A (USP): alpha-Phenyl-2-piperidineacetic 19395-40-5 100mg
Acid
O OH
Ritalinic Acid Hydrochloride H
MM1031.11- N HCl
Related compound A (USP): alpha-Phenyl-2-piperidineacetic 19395-40-5 25mg
0025 Acid
Cl N
MM1031.17 2-Chloropyridine 109-09-1 100mg
O O
MM1031.18- N
Methyl 2-Phenyl-2-(pyridin-2-yl)acetate 26483-64-7 25mg
0025
O
MM0160.03 Phenylacetic Acid 103-82-2 100mg
OH
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-391
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
MM0160.03- O
Phenylacetic Acid 103-82-2 25mg
0025 OH
MM0269.05- N
Phenylacetonitrile (Benzyl Cyanide) 140-29-4 100mg
0100
AND Enantiomer
Methylphenobarbital (Mephobarbital)
O N O
Methylprednisolone
O
OH
HO OH
MM0190.00- H
Methylprednisolone 83-43-2 250mg H H
0250 O
O
Impurity A (EP): 17,21-Dihydroxy-6 - O
OH
OH
MM0190.01- methylpregna-1,4-diene-3,11,20-trione H
91523-05-6 25mg
0025 Related compound A (USP): 17,21-Dihydroxy-6alpha- O
H H
methylpregna-1,4-diene-3,11,20-trione
O
O
Impurity J (EP): 11 ,17-Dihydroxy-6 -methyl-3,20- O
HO OH
MM0191.00- H
dioxopregna-1,4-dien-21-yl Acetate (Methylprednisolone 53-36-1 250mg H H
0250 O
Acetate)
O
OH
HO OH
MM0193.00- Impurity K (EP): 11 ,17,21-Trihydroxypregna-1,4-diene-3,20- H
50-24-8 250mg
0250 H H
dione (Prednisolone) O
Methylprednisolone Acetate
O
O
O
HO OH
MM0191.00-
Methylprednisolone Acetate 53-36-1 250mg H
H
H
0250 O
O
OH
HO OH
MM0190.00- Impurity B (EP): 11 ,17,21-Trihydroxy-6 -methylpregna-1,4- H
83-43-2 250mg H H
0250 diene-3,20-dione (Methylprednisolone) O
O
O
O
MM0194.00- Impurity E (EP): 11 ,17-Dihydroxy-3,20-dioxopregna-1,4- HO OH
H
52-21-1 250mg
0250 dien-21-yl Acetate (Prednisolone Acetate) H H
O
H
O
O
O +
O Na
Methylprednisolone Hydrogen HO
H
OH
O
O
MM0192.00
Succinate Sodium Salt
2375-03-3 request H H
O
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-392
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
O
OH
HO OH
MM0190.00- H
Impurity A (EP): Methylprednisolone 83-43-2 250mg H H
0250 O
O
O
O
HO OH
MM0191.00-
Impurity C (EP): Methylprednisolone Acetate 53-36-1 250mg H
H
H
0250 O
N-Methylpyrrolidone
N O
MM3004.00 N-Methylpyrrolidone 872-50-4 250mg
Methylsulfonal
O O O O
S S
MM3149.00 Methylsulfonal 76-20-0 100mg
Methyltestosterone
OH
H
MM0558.00 Methyltestosterone 58-18-4 250mg
H H
O
OH
MM0323.00- H
Testosterone 58-22-0 250mg
0250 H H
O
Methylthiouracil
H
N S
Metixene Hydrochloride
MM0125.01-
Impurity A (EP): 9H-Thioxanthene 261-31-4 25mg
0025 S
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-393
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
O
Impurity B (EP): 9H-Thioxanthen-9-one
MM0125.02 492-22-8 100mg
(Thioxanthone) S
O
MM0125.02- Impurity B (EP): 9H-Thioxanthen-9-one
492-22-8 25mg
0025 (Thioxanthone) S
H 2N O
0250
Impurity A (EP): 4-(Acetylamino)-5-chloro-N-
O
[2-(diethylamino)ethyl]-2-methoxybenzamide O
Cl
N
N
MM0073.03 H
Related compound A (USP): 4-acetamido-5-chloro-N-[2-
5608-13-9 100mg N O
H
(diethylamino)ethyl]-2-methoxybenzamide
Impurity A (EP): 4-(Acetylamino)-5-chloro-N-
O
MM0073.03- [2-(diethylamino)ethyl]-2-methoxybenzamide O
Cl
N
N
H
Related compound A (USP): 4-acetamido-5-chloro-N-[2-
5608-13-9 25mg N O
0025 H
(diethylamino)ethyl]-2-methoxybenzamide
Impurity B (EP): Methyl 4-(Acetylamino)-5- O
chloro-2-methoxybenzoate O
Cl
O
MM0073.04- chloro-2-methoxybenzoate O
Cl
O
O
MM0073.02- Impurity C (EP): 4-Amino-5-chloro-2- Cl
OH
7206-70-4 25mg
0025 methoxybenzoic Acid
H 2N O
methoxybenzoate O O
MM0073.05
Related compound D (USP): methyl 4-acetamido-2-
4093-29-2 100mg
N O
H
methoxybenzoate
Impurity D (EP): Methyl 4-(Acetylamino)-2- O
MM0073.05- methoxybenzoate O O
O
Impurity F (EP): 4-Amino-5-chloro-N-[2- Cl
N
N
MM0073.06 38339-95-6 100mg
(diethylamino)ethyl]-2-hydroxybenzamide H 2N OH
H
O
MM0073.06- Impurity F (EP): 4-Amino-5-chloro-N-[2- Cl
N
N
38339-95-6 25mg
0025 (diethylamino)ethyl]-2-hydroxybenzamide H 2N OH
H
(Metoclopramide N-Oxide)
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-394
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
H2 N OH
O
MM0073.09-
Methyl 4-Amino-2-hydroxybenzoate 4136-97-4 25mg O
0025 H2 N OH
Methyl 4-(Acetylamino)-2- O O
MM0073.10
hydroxybenzoate
4093-28-1 100mg
N OH
H
hydroxybenzoate
4093-28-1 25mg
0025 N OH
H
Metolazone
O O O
S
MM1306.00 Metolazone 17560-51-9 250mg H 2N N
Cl N
H
Metomidate Hydrochloride
N
O
N
MM3173.00 Metomidate Hydrochloride 35944-74-2 100mg O HCl
Metopimazine
N N
O
S
O O
NH
S
O O
NH
MM1010.03- S
2-Methylsulfonyl-10H-phenothiazine 23503-68-6 25mg
0025
S
O O
Metoprolol Fumarate
OH O
H
2
O
OH
Metoprolol Succinate
OH O
MM0279.00- H
2
O
OH
0250
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-395
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
methoxyethyl)phenoxy]-propan-2-ol
Impurity A (EP): (2RS)-1-(Ethylamino)-3-[4-(2-
methoxyethyl)phenoxy]propan-2-ol
OH
H
MM0027.04- O N
OH
MM0027.01-
Impurity B (EP): 4-(2-Methoxyethyl)phenol 56718-71-9 25mg
0025 O
OH
Impurity F (EP): (2RS)-1-[(1-Methylethyl)amino]- O
H
N
MM0027.08 7695-63-8 100mg
3-phenoxypropan-2-ol
OH
MM0027.08- Impurity F (EP): (2RS)-1-[(1-Methylethyl)amino]- O
H
N
7695-63-8 25mg
0025 3-phenoxypropan-2-ol
OH
OH
MM0027.09-
Impurity G (EP): 2-(4-Hydroxyphenyl)ethanol 501-94-0 25mg
0025 HO
2-ol
[(1-methylethyl)amino]propan-2-ol
MM0027.11 933468-54-3 100mg
OH
MM0027.11- (2RS)-1-(4-Ethenylphenoxy)-3- O
H
N
[(1-methylethyl)amino]propan-2-ol
933468-54-3 25mg
0025
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-396
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
methoxyethyl)phenoxy]propan-2-ol
(2RS)-1-[4-[(EZ)-2-Methoxyethenyl]- OH
H
O N
MM0027.13 phenoxy]-3-[(1methylethyl)amino]propan- 82961-02-2 100mg O
2-ol
MM0027.13- (2RS)-1-[4-[(EZ)-2-Methoxyethenyl]- OH
H
O N
phenoxy]-3-[(1methylethyl)amino]propan- 82961-02-2 25mg O
0025 2-ol
Impurity M (EP) as Dihydrochloride: 1,3-Bis[(1- H
N
OH
H
N
MM0027.28 73313-36-7 100mg HCl
methylethyl)amino]propan-2-ol Dihydrochloride 2
OH
Impurity N (EP): (2RS)-3-[(1-Methylethyl)amino]- HO
H
N
MM0027.16 6452-57-9 100mg
propane-1,2-diol
1486464-40-7 25mg O
HCl
O
Metoprolol Tartrate
OH
H
O N
HO
OH
O OH
OH O
MM0279.00- H
Metoprolol Succinate
O N HO
OH
98418-47-4 250mg O
2
O
0250
Impurity A (EP): (2RS)-1-(Ethylamino)-3-[4-(2-
methoxyethyl)phenoxy]propan-2-ol
OH
H
O N
methoxyethyl)phenoxy]-propan-2-ol
Impurity A (EP): (2RS)-1-(Ethylamino)-3-[4-(2-
methoxyethyl)phenoxy]propan-2-ol
OH
H
MM0027.04- O N
OH
MM0027.01-
Impurity B (EP): 4-(2-Methoxyethyl)phenol 56718-71-9 25mg
0025 O
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-397
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
OH
Impurity D (EP): (2RS)-3-[4-(2-Methoxyethyl)- O OH
MM0027.06 62572-90-1 100mg
phenoxy]propane-1,2-diol O
OH
MM0027.06- Impurity D (EP): (2RS)-3-[4-(2-Methoxyethyl)- O OH
62572-90-1 25mg
0025 phenoxy]propane-1,2-diol O
OH
Impurity F (EP): (2RS)-1-[(1-Methylethyl)amino]- O
H
N
MM0027.08 7695-63-8 100mg
3-phenoxypropan-2-ol
OH
MM0027.08- Impurity F (EP): (2RS)-1-[(1-Methylethyl)amino]- O
H
N
7695-63-8 25mg
0025 3-phenoxypropan-2-ol
OH
OH
MM0027.09-
Impurity G (EP): 2-(4-Hydroxyphenyl)ethanol 501-94-0 25mg
0025 HO
2-ol
OH
MM0027.11- (2RS)-1-(4-Ethenylphenoxy)-3- O
H
N
933468-54-3 25mg
0025 [(1-methylethyl)amino]propan-2-ol
methoxyethyl)phenoxy]propan-2-ol
(2RS)-1-[4-[(EZ)-2-Methoxyethenyl]- OH
H
O N
MM0027.13 phenoxy]-3-[(1methylethyl)amino]propan- 82961-02-2 100mg O
2-ol
MM0027.13- (2RS)-1-[4-[(EZ)-2-Methoxyethenyl]- OH
H
O N
phenoxy]-3-[(1methylethyl)amino]propan- 82961-02-2 25mg O
0025 2-ol
Impurity M (EP) as Dihydrochloride: 1,3-Bis[(1- H
N
OH
H
N
MM0027.28 73313-36-7 100mg HCl
methylethyl)amino]propan-2-ol Dihydrochloride 2
OH
Impurity N (EP): (2RS)-3-[(1-Methylethyl)amino]- HO
H
N
MM0027.16 6452-57-9 100mg
propane-1,2-diol
1486464-40-7 25mg O
HCl
O
MM0027.02
propane
56718-70-8 100mg
O
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-398
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
1-Chloro-3-[4-(2-methoxyethyl)-
OH
phenoxy]propan-2-ol O Cl
(2-methoxyethyl)phenoxy]-propane
OH
4,4'-(2-Hydroxy-1,3-propandiyldioxy)-bis[(2-methoxyethyl) O O
benzene]
OH
MM0027.22 3-Chloropropane-1,2-diol 96-24-2 100mg Cl OH
OH
MM0027.25-
2-Methoxyethylphenol 330976-39-1 100mg
0100 O
1-[2-(2-Methoxyethyl)phenyoxy]-2,3- O O
epoxypropane
MM0027.26 89507-60-8 50mg
O
OH
MM0027.27- 4-[2-[2-Hydroxy-3-(isopropylamino)-
2732276-87-6 25mg N O
0025 propoxy]ethyl]phenol H
OH
OH
O O
2,2'-(2-Hydroxy-1,3-propandiyldioxy)-bis[(2-methoxyethyl)
MM0027.31 n/a 50mg
benzene] (1,3-Bis[2-(2-methoxyethyl)phenoxy]propan-2-ol) O O
OH
H
MM0027.32- O N
1-[4-[2-Hydroxy-3-[(1-methylethyl)amino]propoxy]phenyl]-2- HCl
68416-39-7 25mg O
0025 methoxyethanone Hydrochloride O
OH
MM0027.34- N-Desisopropylmetoprolol (1-Amino-3-[4-(2-methoxyethyl) O NH2
74027-60-4 25mg
0025 O
phenoxy]-2-propanol)
O
O
MM0027.35 1-[4-(2-Methoxyethyl)phenoxy]propan-2-one 1155083-53-6 100mg
O
Metrifonate
Cl Cl O
MM3417.01- Methyl (RS)-(2,2,2-Trichloro-1-hydroxyethyl)phosphonate P OH
684-31-1 25mg Cl
0025 Acid (Desmethylmetrifonate) O
OH
Metronidazole
O
O N+
MM0012.00- OH
Metronidazole 443-48-1 250mg N
0250
N
O
+ NH
MM0012.02 Impurity A (EP): 2-Methyl-4-nitroimidazole 696-23-1 100mg N
O N
O
MM0012.02- + NH
Impurity A (EP): 2-Methyl-4-nitroimidazole 696-23-1 25mg N
0025 O N
O
+ NH
MM0012.05 Impurity B (EP): 4-Nitroimidazole 3034-38-6 100mg N
O N
O
MM0012.05- + NH
Impurity B (EP): 4-Nitroimidazole 3034-38-6 25mg N
0025 O N
OH
Impurity C (EP): 2-(4-Nitro-1H-imidazol-1-yl)- O
N
+ N
MM0012.06 5006-69-9 100mg
ethanol O N
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-399
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
OH
MM0012.06- Impurity C (EP): 2-(4-Nitro-1H-imidazol-1-yl)- O
N
+ N
5006-69-9 25mg
0025 ethanol O N
O
O N+
Impurity D (EP): 2-(5-Nitro-1H-imidazol-1-yl)- OH
MM0012.07 5006-68-8 100mg N
ethanol
N
O
O N+
MM0012.07- Impurity D (EP): 2-(5-Nitro-1H-imidazol-1-yl)- OH
5006-68-8 25mg N
0025 ethanol
N
OH
Impurity E (EP): 2-(2-Methyl-4-nitro-1H- O
N
+ N
MM0012.01 705-19-1 100mg
imidazol-1-yl)ethanol O N
OH
MM0012.01- Impurity E (EP): 2-(2-Methyl-4-nitro-1H- O
N
+ N
705-19-1 25mg
0025 imidazol-1-yl)ethanol O N
O
O +
O
O +
MM0012.08- Impurity F (EP): 2-[2-(2-Methyl-5-nitro-1H- N
O
16156-94-8 25mg N OH
0025 imidazol-1-yl)ethoxy]ethanol N
O
O N+
Impurity G (EP): 2-(2-Methyl-5-nitro-1H- OH
MM0012.09 1010-93-1 100mg N
imidazol-1-yl)acetic Acid O
N
O
O N+
MM0012.09- Impurity G (EP): 2-(2-Methyl-5-nitro-1H- OH
1010-93-1 25mg N
0025 imidazol-1-yl)acetic Acid O
N
O
O N+
1-(2-Hydroxyethyl)-2-hydroxymethyl-5-nitro- OH
N
imidazole (Hydroxymetronidazole)
MM0012.04 4812-40-2 100mg
N OH
O
O N+
MM0012.04- 1-(2-Hydroxyethyl)-2-hydroxymethyl-5-nitro- OH
N
imidazole (Hydroxymetronidazole)
4812-40-2 25mg
0025
N OH
O
O N+
N
MM0012.10- N
2-[2-(2-Methyl-4-nitro-1H-imidazol-1-yl)ethoxy]ethanol 19765-12-9 25mg
0025
O
HO
O
N O N
+
Metronidazole Benzoate
O
O +
N
MM0278.00-
Metronidazole Benzoate 13182-89-3 250mg N
O
0250 O
N
O
O N+
MM0012.00- Impurity A (EP):2-(2-Methyl-5-nitro-1H-imidazol-1-yl)ethanol OH
443-48-1 250mg N
0250 (Metronidazole)
N
O
Impurity B (EP): 2-Methyl-4-nitroimidazole (2-Methyl-5- + NH
MM0012.02 696-23-1 100mg N
nitroimidazole) O N
O
MM0012.02- Impurity B (EP): 2-Methyl-4-nitroimidazole (2-Methyl-5- + NH
696-23-1 25mg N
0025 nitroimidazole) O N
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-400
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
O
MM0278.01-
Impurity C (EP): Benzenecarboxylic Acid (Benzoic Acid) 65-85-0 250mg OH
0250
2-(2-Methyl-4-nitro-1H-imidazol-1-yl)- O
+ N
O
ethyl Benzoate
MM0278.04 87009-72-1 100mg N
O
O N
MM0278.04- 2-(2-Methyl-4-nitro-1H-imidazol-1-yl)- O
+ N
O
ethyl Benzoate
87009-72-1 25mg N
O
0025 O N
Metyrapone
O
N
MM1694.00 Metyrapone 54-36-4 100mg N
Mevastatin
O
O
+
Na
OH O
MM0377.01-
Mevastatin Acid Sodium Salt 99782-89-5 25mg H
O O
OH
0025
Mexiletine Hydrochloride
NH2
MM0146.00- O
HCl
Mexiletine Hydrochloride 5370-01-4 250mg
0250
OH
MM0146.01 Impurity A (EP): 2,6-Dimethylphenol 576-26-1 100mg
MM0146.01- OH
Impurity A (EP): 2,6-Dimethylphenol 576-26-1 25mg
0025
O
Impurity B (EP): 1-(2,6-Dimethylphenoxy)propan- O
MM0146.02 53012-41-2 100mg
2-one
Mianserin Hydrochloride
N
N
N
N
Impurity A (EP): [2-[(2RS)-4-Methyl-2-phenyl-
MM0147.01 57321-32-1 100mg
piperazin-1-yl]phenyl]methanol
OH
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-401
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
N
N
MM0147.01- Impurity A (EP): [2-[(2RS)-4-Methyl-2-phenyl-
57321-32-1 25mg
0025 piperazin-1-yl]phenyl]methanol
OH
NH2
NH2
MM0147.04-
Impurity C (EP): (2-Aminophenyl)methanol 5344-90-1 25mg OH
0025
Miconazole Nitrate
Cl
O
MM0281.00- Cl
Miconazole Nitrate 22832-87-7 250mg O
HO N
+
O
0250 N
Cl Cl
N
Cl
Cl
MM0074.00 Miconazole 22916-47-8 250mg
O
N
Cl Cl
N
Cl
Impurity A (EP): (1RS)-1-(2,4-Dichlorophenyl)-
MM0281.01 24155-42-8 100mg N
2-(1H-imidazol-1-yl)ethanol Cl OH
N
Cl
MM0281.01- Impurity A (EP): (1RS)-1-(2,4-Dichlorophenyl)-
24155-42-8 25mg N
0025 2-(1H-imidazol-1-yl)ethanol Cl OH
N
Cl
24169-02-6 250mg
0250 ethyl]-1H-imidazole Nitrate (Econazole O
N
O
Cl
Nitrate) N
Dichlorobenzyl)oxy]-2-(2,4-dichloro-
O
MM0281.03 phenyl)ethanamine Nitrate n/a 100mg Cl
HO N
+
O
O
Related compound C (USP): 2-[(2,4-Dichlorobenzyl)oxy]-2- Cl Cl
N H2
(2,4-dichlorophenyl)ethan-1-amine
Impurity C (EP) as Nitrate: (2RS)-2-[(2,4- Cl
MM0281.03- Dichlorobenzyl)oxy]-2-(2,4-dichloro-
O
phenyl)ethanamine Nitrate n/a 25mg Cl
HO N
+
O
O
0025 Related compound C (USP): 2-[(2,4-Dichlorobenzyl)oxy]-2- Cl Cl
N H2
(2,4-dichlorophenyl)ethan-1-amine
Cl
Nitrate) Cl
N
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-402
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
Dichlorobenzyl)oxy]-2-(2,4-dichloro- O
Cl
phenyl)ethyl]-1H-imidazole Nitrate
+
HO N
MM0281.06 27220-35-5 100mg O O
Cl N
(2,4-dichlorophenyl)ethyl-1H-imidazole
Impurity F (EP) as Nitrate: 1-[(2RS)-2-[(3,4- Cl
MM0281.06- Dichlorobenzyl)oxy]-2-(2,4-dichloro- O
Cl
phenyl)ethyl]-1H-imidazole Nitrate
+
HO N
27220-35-5 25mg O O
0025 Related compound F (USP): 1-2-[(3,4-dichlorobenzyl)oxy]-2- Cl
N
Cl N
(2,4-dichlorophenyl)ethyl-1H-imidazole
Cl
phenyl)ethyl]-1H-imidazole Nitrate Cl
N
Cl
Cl
imidazole Nitrate N
Cl
Chlorobenzyl)oxy]-2-(2,4-dichloro- Cl
O
+
MM0281.09 phenyl)ethyl]-1H-imidazole Nitrate 24169-00-4 100mg O
HO N
O
(2,4-dichlorophenyl)ethyl-1H-imidazole N
MM0281.09- Chlorobenzyl)oxy]-2-(2,4-dichloro- Cl
O
+
phenyl)ethyl]-1H-imidazole Nitrate 24169-00-4 25mg O
HO N
O
0025 Related compound I (USP): 1-2-[(2-Chlorobenzyl)oxy]-2- Cl
N
(2,4-dichlorophenyl)ethyl-1H-imidazole N
Cl
Cl
MM0281.10 1-(2,4-Dichlorobenzoylmethyl)imidazole 46503-52-0 100mg
O
N
Cl
MM0281.10- Cl
1-(2,4-Dichlorobenzoylmethyl)imidazole 46503-52-0 25mg
0025
O
N
Cl
MM0281.11- N-[2-(2,4-Dichlorophenyl)-2-[(2,4-dichlorophenyl)- Cl
methoxy]ethyl]formamide
911805-54-4 25mg
0025 O
HN
Cl Cl
O
Cl
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-403
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
Midazolam
N
MM1106.00-
Midazolam 59467-70-8 CS 250mg Cl N
0250
F
N O
N OH
MM1106.11- Impurity C (EP): 8-Chloro-6-(2-fluorophenyl)-1-methyl-4H-
59468-44-9 25mg Cl N
0025 imidazo[1,5-a][1,4]benzodiazepine-3-carboxylic Acid F
H
N NH2
H O
N
H O
N
N
Impurity H (EP): 6-Chloro-4-(2-fluorophenyl)-2- Cl
MM1106.08 119401-13-7 100mg
methylquinazoline F
N
MM1106.08- Impurity H (EP): 6-Chloro-4-(2-fluorophenyl)-2- Cl
119401-13-7 25mg
0025 methylquinazoline F
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-404
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
MM1106.13- 1-[4-Chloro-2-(2-fluorobenzoyl)phenyl]-2-methyl-1H- O
n/a 25mg Cl O
0025 imidazole-5-carboxaldehyde
F
N
O
MM1106.15- 3-[4-Chloro-2-(2-fluorobenzoyl)phenyl]-2-methyl-3H-
151921-06-1 25mg Cl O OH
0025 imidazole-4-carboxylic Acid
F
Midazolam Hydrochloride
N
Midazolam Maleate
N
N O
OH
MM3404.00 Midazolam Maleate 59467-94-6 CS 250mg Cl N
OH
F O
O O OH
O
+
N
Midazolam Maleic Acid Addukt (3-Carboxy-2-[8-chloro-6-(2-
MM1106.14- N
fluorophenyl)-1-methyl-4H-imidazo[1,5-a][1,4] 2531288-23-8 25mg
0025 Cl N
benzodiazepine-2-ium-2-yl]propanoate)
F
Midodrine Hydrochloride
2-Amino-1-(2,5-dimethoxyphenyl)ethanol OH
O NH2
MM3328.01 Related compound A (USP): 2-amino-1-(2,5- 3600-87-1 100mg
O
dimethoxyphenyl)ethanol
2-Amino-1-(2,5-dimethoxyphenyl)ethanol OH
MM3328.01- O NH2
Related compound A (USP): 2-amino-1-(2,5- 3600-87-1 25mg
0025 O
dimethoxyphenyl)ethanol
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-405
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
Mifepristone
N
OH
H
O
O
+
N
OH
H
O
O
+
N
OH
MM1007.02-
Mifepristone N-Oxide 91934-98-4 25mg H
0025 H
O
H
MM1007.03 Estra-4,9-diene-3,17-dione 5173-46-6 100mg
H
O
MM1007.03- H
Estra-4,9-diene-3,17-dione 5173-46-6 25mg
0025 H
O
MM1274.02- Spiro[1,3-dioxolan-2,3'-estra-5'(10'),9'(11')-dien]-17'-one H
5571-36-8 25mg O H
0025 (Estra-5(10),9(11)-diene-3,17-dione 3-Ethylene
O
Milnacipran Hydrochloride
AND Enantiomer
O
Milrinone
H
N O
H
6-Methyl-2-oxo-5-(4-pyridyl)-1H-pyridine-3-carboxamide N O
N O
(3,4'-bipyridine)-5-carboxamide
H
6-Methyl-2-oxo-5-(4-pyridyl)-1H-pyridine-3-carboxamide N O
MM1539.01- NH2
Related compound A (USP): 1,6-Dihydro-2-methyl-6-oxo 80047-24-1 25mg
0025 N O
(3,4'-bipyridine)-5-carboxamide
Minoxidil
N N N H2
MM0521.00 Minoxidil 38304-91-5 500mg N
+
O
NH2
Cl N NH2
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-406
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
Cl N NH2
Cl N NH2
N H2
Cl N NH2
MM0521.02-
Impurity B (EP): 6-Chloropyrimidine-2,4-diamine 156-83-2 25mg N
0025
N H2
2,4-diamine NH2
N N N H2
MM0521.06 5-Chloro-6-(piperidin-1-yl)pyrimidine-2,4-diamine 1784008-01-0 100mg N
Cl
NH2
N N N H2
MM0521.06-
5-Chloro-6-(piperidin-1-yl)pyrimidine-2,4-diamine 1784008-01-0 25mg N
0025 Cl
NH2
MM0521.07- N N
[2-Cyano-1-(piperidin-1-yl)ethylidene]cyanamide 56488-00-7 25mg N
0025
N
MM0521.08- N O
3-Oxo-3-(piperidin-1-yl)propanenitrile 15029-30-8 25mg
0025
N
Mirabegron
N H2
S N
MM3776.00-
Mirabegron 223673-61-8 250mg O
N
H
OH
0250 N
H
N H2
S N
MM3776.01-
2-Aminothiazole-4-acetic Acid 29676-71-9 25mg O
0025
OH
Mirtazapine
MM1005.00- N
Mirtazapine 85650-52-8 250mg N
0250
N
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-407
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
O
Impurity A (EP): (14bRS)-2-Methyl-1,2,3,4,10- N
+
O
MM1005.02- Impurity A (EP): (14bRS)-2-Methyl-1,2,3,4,10- N
+
hexahydropyrazino[2,1-a]pyrido[2,3-c][2]benzazepine
tetrahydrobenzo[c]pyrazino[1,2-a]pyrido[3,2-f]azepin-10 N
(14bH)-one
Impurity F (EP): (14bRS)-2-Methyl-1,3,4,14b-
tetrahydropyrazino[2,1-a]pyrido-[2,3-c][2]benzazepin-10(2H)-
MM1005.06- one (10-Oxomirtazapine) O
N
(14bH)-one
MM1005.07-
1-Methyl-3-phenylpiperazine 5271-27-2 25mg N
0025 HN
OH
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-408
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
N Cl
N Cl
MM1005.11-
2-Chloropyridine-3-carbonitrile (2-Chloronicotinonitrile) 6602-54-6 25mg
0025
N
Mitomycin
O
H
H 2N O N
O
H 2N O
O
MM1308.01- NH2
Impurity A (EP): (E)-3-Phenylprop-2-enamide (Cinnamamide) 22031-64-7 25mg
0025
Mitoxantrone Hydrochloride
H
N
HO NH O OH
HO NH O OH
N
H
Moclobemide
O O
MM0250.00-
Moclobemide 71320-77-9 250mg N
H
N
0250 Cl
O
OH
N
MM0250.02 4-Chloro-N-(2-hydroxyethyl)benzamide 7400-54-6 100mg H
Cl
O
MM0250.02- OH
N
4-Chloro-N-(2-hydroxyethyl)benzamide 7400-54-6 25mg H
0025 Cl
O O
MM0250.03- +
N
Moclobemide N-Oxide 64544-24-7 25mg N
H O
0025 Cl
O
MM0250.05- O
Methyl 4-Chlorobenzoate 1126-46-1 25mg
0025
Cl
O
MM0250.06- NH2
4-Chlorobenzamide 619-56-7 25mg
0025
Cl
Modafinil
O O
S
NH2
MM0540.00 Modafinil 68693-11-8 250mg
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-409
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
O O
S
Impurity C (EP): Methyl [(RS)-(Diphenylmethyl)sulfinyl]- O
MM0540.03 63547-25-1 50mg
acetate
O
2-[(Diphenylmethyl)sulfenyl]acetamide S
NH2
MM0540.04 Related compound C (USP): 2-[(diphenylmethyl)sulfenyl] 68524-30-1 50mg
acetamide
Bis(diphenylmethyl) Ether O
Related compound D (USP): Bis(diphenylmethyl)ether
MM0599.14 574-42-5 50mg
Bis(diphenylmethyl)disulfide S
S
MM0540.06 Related compound E (USP): Bis(diphenylmethyl)disulfide 1726-02-9 50mg
Moexipril Hydrochloride
(S)-tert-Butyl 2-[(S)-2-[(S)-1-Ethoxy-1-oxo-4-phenylbutan-2-
ylamino]propanoyl]-6,7-dimethoxy-1,2,3,4-
O
tetrahydroisoquinoline-3-carboxylate Maleate (Moexipril tert- O O
MM3425.01- NH OH
O OH
Butyl Ester Maleate) 103733-40-0 25mg N O
O
0025 O
O
O
Related compound C (USP): (S)-tert-butyl 2-(S)-2-[(S)-1-
ethoxy-1-oxo-4-phenylbutan-2-ylamino]propanoyl-6,7-
dimethoxy-1,2,3,4-tetrahydroisoquinoline-3-carboxylate
(S)-2-[(S)-1-Ethoxy-1-oxo-4-phenylbutan-2-ylamino]propanoic
O
Acid ((2S)-2-[[(1S)-1-(Ethoxycarbonyl)-3-phenylpropyl]amino] H
N
OH
MM0010.05 propanoic Acid) 82717-96-2 100mg O O
Molsidomine
O
O O
N
N
MM0267.00 Molsidomine 25717-80-0 250mg N
+
N
O
O
N
MM0267.03 Impurity B (EP): 4-Nitrosomorpholine 59-89-2 100mg N
O
O
MM0267.03- N
Impurity B (EP): 4-Nitrosomorpholine 59-89-2 25mg N
0025
O
N
N
Impurity C (EP): (2E)-(Morpholin-4-ylimino)- N
MM0267.01 26179-71-5 100mg
acetonitrile O
N
N
MM0267.01- Impurity C (EP): (2E)-(Morpholin-4-ylimino)- N
26179-71-5 25mg
0025 acetonitrile O
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-410
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
HN
MM0267.06 Impurity E (EP): Morpholine 110-91-8 100mg
O
H
N
MM0267.10- O O
1,3-Oxazolidin-2,4-dione 2346-26-1 25mg
0025
O
O
HO
MM0267.11 4-(Hydroxyacetyl)morpholine 51068-78-1 100mg N
O
O
MM0267.11- HO
4-(Hydroxyacetyl)morpholine 51068-78-1 25mg N
0025 O
Mometasone Furoate
Cl
O O
MM1272.00- HO O
Mometasone Furoate 83919-23-7 250mg H O
0250 Cl H
O
Cl
MM1272.04- O
0025 H H
carboxylate O
O O
dioxopregna-1,4-diene-11 ,17-diyl Bis(furan- 1370190-33-2 25mg H O
0025
2-carboxylate) O
Cl H
Cl
O O
Furan-2-carboxylate
0025 O
O
Cl
O
OH
O O
OH
O
HO OH
MM1272.12- Impurity M (EP): 9-Chloro-11 ,17-dihydroxy-16 - H
57780-86-6 25mg
0025 methylpregna-1,4-diene-3,20-dione Cl H
O
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-411
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
O O
O S
Impurity N (EP): 9-Chloro-11 ,17-dihydroxy-16 -methyl-3,20- O
MM1272.13- HO OH
dioxopregna-1,4-dien-21-yl Methanesulfonate (Icometasone 352315-75-4 25mg H
0025 Cl H
21-Mesylate) O
O
Impurity O (EP): 9-Chloro-11 ,17-dihydroxy-16 -methyl-3,20- O
MM1272.14- HO OH
dioxopregna-1,4-dien-21-yl Acetate (Icometasone 21- 24916-91-4 25mg H
0025 Cl H
Acetate) O
Cl
O
O O
O S
Impurity R (EP): 9-Chloro-11 -hydroxy-16 -methyl-21- O O
MM1272.17- HO O
[(methylsulfonyl)oxy]-3,20-dioxopregna-1,4-dien-17-yl Furan- 1370190-08-1 25mg H O
0025 Cl H
2-carboxylate O
Cl
O O
Impurity S (EP): 9,21-Dichloro-11 -hydroxy-16 -methyl-3,20-
MM1272.18- HO O
H O
dioxopregna-1,4-dien-17-yl Furan-2-carboxylate (16-epi- 2231764-75-1 25mg
0025 Cl H
Mometasone Furoate) O
Cl
O O
HO O
MM1272.24- H O
6- -Hydroxy Mometasone Furoate 132160-74-8 25mg Cl H
0025 O
OH
O
O Ca
2+
O
O Mg
2+
Montelukast Sodium
O +
Na
Cl N S
O
O
Cl N S
OH
HO
O
Cl N S
OH
HO
MM0698.15-
Montelukast Dicyclohexylamine 577953-88-9 25mg
0025 H
N
OH
OH
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-412
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
O
H
Cl N S
OH
MM0698.12- H
0025 O OH
Cl
O
Cl N S
O
HO
MM0698.16 Montelukast Methyl Ester 855473-51-7 100mg
O
Cl N S
O
HO
MM0698.17 Montelukast Ethyl Ester 1044705-96-5 100mg
O
Cl N S
O
MM0698.18- HO
Montelukast Isopropyl Ester n/a 25mg
0025
Cl N OH
(1R)-1-[3-[(E)-2-(7-Chloro-2-quinolyl)vinyl]phenyl]-3-[2-(1-
HO
MM0698.21 150026-75-8 100mg
hydroxy-1-methylethyl)phenyl]propan-1-ol
Cl N OH
MM0698.21- (1R)-1-[3-[(E)-2-(7-Chloro-2-quinolyl)vinyl]phenyl]-3-[2-(1-
HO
150026-75-8 25mg
0025 hydroxy-1-methylethyl)phenyl]propan-1-ol
Cl N OH
MM0698.22- (1S)-1-[3-[(E)-2-(7-Chloro-2-quinolyl)ethenyl]phenyl]-3-[2-(1-
HO
287930-77-2 100mg
0100 hydroxy-1-methylethyl)phenyl]propan-1-ol
Cl N OH
MM0698.22- (1S)-1-[3-[(E)-2-(7-Chloro-2-quinolyl)ethenyl]phenyl]-3-[2-(1-
HO
287930-77-2 25mg
0025 hydroxy-1-methylethyl)phenyl]propan-1-ol
O
MM0698.23- 1-(Mercaptomethyl)cyclopropaneacetic Acid (2-[1-
162515-68-6 25mg HS
0025 (Sulfanylmethyl)cyclopropyl]acetic Acid) OH
MM0698.34- (E)-1-[3-[2-(7-Chloroquinolin-2-yl)ethenyl]phenyl]-2-propen-1- Cl N OH
149968-10-5 25mg
0025 ol
HO
MM0698.38- O
[1-[(Benzyloxy)methyl]cyclopropyl]methanol 177200-76-9 100mg
0100
Morinamide Hydrochloride
O
Moroxydine Hydrochloride
NH NH
Morphine Hydrochloride
N
HO O OH
HO O OH
OH
H2O
MM0442.00 41444-62-6 CS 100mg O
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-413
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
2,2'-Bismorphine) N
2,2'-Bismorphine)
0025 N
HO N
N
HO O O
H
N
HO O O
MM0037.02- H
H
N
H
MM0037.14 6-Acetylmorphine 2784-73-8 CS 100mg
O
HO O O
MM0037.14- H
6-Acetylmorphine 2784-73-8 CS 25mg
0025 O
HO O O
MM0037.15- O H
HO OH
MM0037.17- H
Heroin (Diacetylmorphine) 561-27-3 CS 50mg
0050 O O
O O O
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-414
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
MM0037.24- H O O
Morphine Sulphate
N
O
HO O OH
2
OH
H2O
MM0442.00 41444-62-6 CS 100mg O
2,2'-Bismorphine) N
2,2'-Bismorphine)
0025 N
HO N
Moxifloxacin Hydrochloride
H
O
N HCl
MM0885.00- H
H
N N
Moxifloxacin Hydrochloride 186826-86-8 250mg OH
0250 F
O O
dihydro-7-[(4aS,7aS)-octahydro-6H-pyrrolo[3,4-b]pyridin-6-yl]-4- O O
oxo-3-quinolinecarboxylic acid
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-415
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
OH
1-Cyclopropyl-6,7-difluoro-1,4-dihydro-8-hydroxy-4-oxo-3- F N
MM0885.01 154093-72-8 100mg
quinolinecarboxylic Acid OH
F
O O
OH
MM0885.01- 1-Cyclopropyl-6,7-difluoro-1,4-dihydro-8-hydroxy-4-oxo-3- F N
154093-72-8 25mg
0025 quinolinecarboxylic Acid OH
F
O O
Ester)
H
O
MM0885.10- N
HH N N
Moxifloxacin Ethyl Ester 1403836-23-6 25mg O
0025 F
O O
H
O
MM0885.11- N
HH N N
Moxifloxacin Isopropyl Ester 1585176-91-5 25mg O
0025 F
O O
1-Cyclopropyl-6,7-difluoro-1,4-dihydro-8-methoxy-4-oxo-3- F N
MM0885.13 112811-72-0 100mg OH
quinolinecarboxylic Acid F
O O
MM0885.13- 1-Cyclopropyl-6,7-difluoro-1,4-dihydro-8-methoxy-4-oxo-3- F N
112811-72-0 25mg OH
0025 quinolinecarboxylic Acid F
O O
1-Cyclopropyl-6,7,8-trifluoro-1,4-dihydro-4-oxoquinoline-3- F N
MM0885.14 94695-52-0 100mg
carboxylic Acid OH
F
O O
MM0885.14- 1-Cyclopropyl-6,7,8-trifluoro-1,4-dihydro-4-oxoquinoline-3- F N
94695-52-0 25mg
0025 carboxylic Acid OH
F
O O
O
MM0885.16- 1-Cyclopropyl-6,7-difluoro-8-methoxy-4-oxo-1,4- F N
112811-71-9 25mg O
0025 dihydroquinoline-3-carboxylic Acid Ethyl Ester F
O O
MM0885.17- 1-Cyclopropyl-6,7-difluoro-1,4-dihydro-4-oxoquinoline-3- F N
93107-30-3 25mg
0025 carboxylic Acid OH
F
O O
O
MM0885.19- 1-Cyclopropyl-8-ethoxy-6,7-difluoro-1,4-dihydro-4-oxo-3- F N
172602-83-4 25mg O
0025 quinolinecarboxylic Acid Ethyl Ester F
O O
O
MM0885.20- 7-Amino-1-cyclopropyl-6-fluoro-1,4-dihydro-8-methoxy-4-oxo- H 2N N
172426-88-9 25mg OH
0025 3-quinolinecarboxylic Acid F
O O
H
O
MM0885.22- N
H N N
H HCl
(R,R)-Moxifloxacin Hydrochloride 1394029-14-1 25mg F
OH
0025 O O
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-416
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
Moxisylyte Hydrochloride
O
O N
Moxonidine
N Cl
HN
MM1278.00- N
Moxonidine 75438-57-2 250mg N N
H
0250 O
N Cl
Impurity A (EP): 4,6-Dichloro-N-(imidazolidin-2- HN
N Cl
MM1278.01- Impurity A (EP): 4,6-Dichloro-N-(imidazolidin-2- HN
N Cl
MM1278.07- N
4,6-Dichloro-2-methylpyrimidin-5-amine 39906-04-2 25mg NH2
0025
Cl
Mupirocin
O OH
OH OH O
O O
O
2+
Ca H 2O
O 2
MM3467.00 Mupirocin Calcium Dihydrate 115074-43-6 250mg OH
O
OH OH O
2
Mupirocin Calcium
O O
O OH
Mycophenolate Mofetil
O OH
MM1001.00- O
0250
Impurity E (EP): Methyl (4E)-6-(4-Hydroxy-6-methoxy-7- O OH
O
enoate
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-417
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
(4-Hydroxy-6-methoxy-7-methyl-3-oxo-1,3-
O O
O +
N
O
MM1001.07 224052-51-1 100mg O O
dihydroisobenzofuran-5-yl)-4-methylhex-4- O
enoate N-Oxide
Impurity H (EP): 7-Hydroxy-5-methoxy-4-methyl-
6-[2-[(2RS)-2-methyl-5-oxotetrahydrofuran-2- O OH
MM1001.08- yl]ethyl]isobenzofuran-1(3H)-one O O
O
Related compound B (USP): (RS)-7-hydroxy-5-methoxy-4-
26675-76-3 25mg O
0025
methyl-6-[2-(5-methyl-2-oxo-tetrahydrofuran-5-yl)ethyl]-3H-
isobenzofuranyl-1-one
O OH
O
O
MM1001.09 Ethyl Mycophenolate 32483-51-5 100mg O
O
O OH
MM1001.09- O
O
Ethyl Mycophenolate 32483-51-5 25mg O
O
0025
O OH
O
MM1001.10- O
Isopropyl Mycophenolate 40336-80-9 25mg O
O
0025
HO
MM1001.11- N
2-(4-Morpholinyl)ethanol 622-40-2 100mg O
0100
Mycophenolate Sodium
O OH
O
MM1001.08- 2-methyl-5-oxotetrahydrofuran-2-yl]ethyl]-2-benzofuran-1 O
Methyl (4E)-6-(4-Hydroxy-6-methoxy-7-methyl-3-oxo-1,3- O
O
MM1001.05 O
dihydroisobenzofuran-5-yl)-4-methylhex-4-enoate
31858-66-9 100mg O
O OH
31858-66-9 25mg O
0025 dihydroisobenzofuran-5-yl)-4-methylhex-4-enoate O
O OH
O
O
MM1001.09 Ethyl Mycophenolate 32483-51-5 100mg O
O
O OH
MM1001.09- O
O
Ethyl Mycophenolate 32483-51-5 25mg O
O
0025
O OH
MM1001.10- O
O
Isopropyl Mycophenolate 40336-80-9 25mg O
O
0025
Nabumetone
O
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-418
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
OH
Impurity C (EP): (2RS)-4-(6-Methoxynaphthalen-
MM0153.04 65726-24-1 100mg
2-yl)-butan-2-ol O
OH
MM0153.04- Impurity C (EP): (2RS)-4-(6-Methoxynaphthalen-
65726-24-1 25mg
0025 2-yl)-butan-2-ol O
O
Impurity D (EP): (E)-4-(6-Methoxynaphthalen-
MM0153.05 127053-22-9 100mg
2-yl)-but-3-en-2-one O
O
MM0153.05- Impurity D (EP): (E)-4-(6-Methoxynaphthalen-
127053-22-9 25mg
0025 2-yl)-but-3-en-2-one O
O
MM0153.07- Impurity F (EP): 6,6'-Dimethoxy-2,2'-
29619-45-2 25mg
0025 binaphthalenyl O
(6-Methoxy-2-naphthyl)acetic Acid OH
Acid, -Demethylnaproxen)
(6-Methoxy-2-naphthyl)acetic Acid OH
MM0152.01-
((6-Methoxynaphthalen-2-yl)acetic 23981-47-7 25mg O
O
0025 Acid, -Demethylnaproxen)
Nadolol
Naepaine Hydrochloride
O
H
Naepaine Hydrochloride
N
O HCl
MM3146.00 614-42-6 100mg H 2N
Nafcillin Sodium
HO
O
O
HN
MM0392.02 Penilloic Acids of Nafcillin 940306-33-2 100mg H
N
S
HO
O
O
MM0392.02- HN
Penilloic Acids of Nafcillin 940306-33-2 25mg H
N
S
0025
O
O
OH
O
MM0026.04 6-Aminopenicillanic Acid 551-16-6 100mg N
H 2N S
H
O
OH
MM0026.04- O
6-Aminopenicillanic Acid 551-16-6 25mg N
0025 S
H 2N
H
O OH
O
MM0392.04 2-Ethoxynaphthoic Acid 2224-00-2 100mg
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-419
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
O OH
MM0392.04- O
2-Ethoxynaphthoic Acid 2224-00-2 25mg
0025
Naftazone
O
MM1046.00- N
Naftazone 15687-37-3 250mg NH
0250 O NH2
O O
N N
MM1046.01- 3-Bis[(1-oxo-2-naphthylidene)amino]urea (Naftazone Impurity N N
H H
n/a 25mg O
0025 Blue)
O OH
O
Nalbuphine Hydrochloride
HO O OH
O
+
N
HO O OH
O
+
N
MM0341.02-
Nalbuphine N-Oxide Hydrochloride n/a 25mg HO HCl
0025
HO O OH
Nalidixic Acid
N N
MM3144.00 Nalidixic Acid 389-08-2 250mg OH
O O
N N
MM3144.01 Nalidixic Acid Methyl Ester 63475-29-6 100mg O
O O
N N
MM3144.01-
Nalidixic Acid Methyl Ester 63475-29-6 25mg O
0025
O O
MM3144.02- N N
MM3144.03- N N
Nalorphine Hydrochloride
N
HO O OH
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-420
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
HO O O
H
N
Impurity A (EP) as Hydrochloride: 4,5 -Epoxy-3,14-
HO HCl
MM0673.03 dihydroxymorphinan-6-one Hydrochloride (Noroxymorphone 52446-24-9 100mg
Hydrochloride) HO O O
H
N
O +
N
HO O O
O +
N
MM0272.03-
Naloxone N-Oxide 112242-14-5 25mg HO
0025
HO O O
Naltrexone Hydrochloride
N
HO O O
HO
MM0233.04 Naltrexone 16590-41-3 250mg
HO O O
H
N
Impurity B (EP) as Hydrochloride: 4,5 -Epoxy-3,14-
HO HCl
MM0673.03 dihydroxymorphinan-6-one Hydrochloride (Noroxymorphone 52446-24-9 100mg
Hydrochloride) HO O O
H
N
Impurity B (EP) as Hydrochloride: 4,5 -Epoxy-3,14-
MM0673.03- HO HCl
dihydroxymorphinan-6-one Hydrochloride (Noroxymorphone 52446-24-9 25mg
0025
Hydrochloride) HO O O
N
7-Naltrexone (7,8-Didehydronaltrexone; (5 )-17-
HO
MM0233.08 (Cyclopropylmethyl)-7,8-didehydro-4,5-epoxy-3,14- 123086-68-0 25mg
dihydroxymorphinan-6-one) HO O O
Nandrolone
OH
H H
MM0660.00 Nandrolone 434-22-0 250mg
H H
O
19-Norandrost-4-ene-3,17-dione H H
MM0660.01
(Estr-4-ene-3,17-dione)
734-32-7 100mg
H H
O
MM0660.01- 19-Norandrost-4-ene-3,17-dione H H
(Estr-4-ene-3,17-dione)
734-32-7 25mg
0025 H H
O
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-421
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
OH
H
MM0123.15 Estradiol 3-Methyl Ether 1035-77-4 100mg
H H
O
OH
MM0123.15- H
Estradiol 3-Methyl Ether 1035-77-4 25mg
0025 H H
O
Nandrolone Decanoate
O
O
H
H
H
O
OH
Nandrolone Phenpropionate
O
H H
O
Naphazoline Hydrochloride
HN
MM0075.00- N
Naphazoline Hydrochloride 550-99-2 250mg HCl
0250
Hydrochloride (Naphthylacetylethylenediamine N
H
NH2
HCl
Hydrochloride)
MM0075.06 73664-32-1 100mg
Related compound A (USP): N-(2-Aminoethyl)-2-
(naphthalen-1-yl)acetamide
Impurity A (EP) as Hydrochloride: N-(2-
Aminoethyl)-2-(naphthalen-1-yl)acetamide O
HCl
Hydrochloride)
73664-32-1 25mg
0025
Related compound A (USP): N-(2-Aminoethyl)-2-
(naphthalen-1-yl)acetamide
O
OH
Impurity B (EP): (Naphthalen-1-yl)acetic Acid
MM0075.02 86-87-3 100mg
(1-Naphthylacetic Acid)
OH
MM0075.02- Impurity B (EP): (Naphthalen-1-yl)acetic Acid
86-87-3 25mg
0025 (1-Naphthylacetic Acid)
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-422
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
Naphazoline Hydrochloride)
O
O
MM0075.05 Ethyl (1-Naphthyl)acetate 2122-70-5 100mg
N H2
(Naphthalen-1-yl)acetamide
MM0075.07
(1-Naphthylacetamide)
86-86-2 100mg
N H2
MM0075.07- (Naphthalen-1-yl)acetamide
(1-Naphthylacetamide)
86-86-2 25mg
0025
Naphazoline Nitrate
HN
N O
MM0286.00 Naphazoline Nitrate 5144-52-5 500mg HO N
+
Hydrochloride (Naphthylacetylethylenediamine N
H
NH2
HCl
MM0075.06
Hydrochloride)
73664-32-1 100mg
Related compound A (USP): N-(2-Aminoethyl)-2-
(naphthalen-1-yl)acetamide
Impurity A (EP) as Hydrochloride: N-(2-
Aminoethyl)-2-(naphthalen-1-yl)acetamide O
HCl
Hydrochloride)
73664-32-1 25mg
0025
Related compound A (USP): N-(2-Aminoethyl)-2-
(naphthalen-1-yl)acetamide
O
OH
Impurity B (EP): (Naphthalen-1-yl)acetic Acid
MM0075.02 86-87-3 100mg
(1-Naphthylacetic Acid)
OH
MM0075.02- Impurity B (EP): (Naphthalen-1-yl)acetic Acid
86-87-3 25mg
0025 (1-Naphthylacetic Acid)
O
MM0075.05 Ethyl (1-Naphthyl)acetate 2122-70-5 100mg
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-423
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
N H2
(Naphthalen-1-yl)acetamide
MM0075.07
(1-Naphthylacetamide)
86-86-2 100mg
N H2
MM0075.07- (Naphthalen-1-yl)acetamide
(1-Naphthylacetamide)
86-86-2 25mg
0025
Naproxen
OH
MM0152.00 Naproxen 22204-53-1 500mg O
O
(5-Chloronaproxen) Cl
(5-Bromonaproxen) Br
(5-Iodonaproxen) I
2-yl)propanoic acid
Impurity G (EP): (2R)-2-(6-Methoxynaphthalen-2-yl)
MM0152.25- propanoic Acid ((R)-Naproxen) OH
2-yl)propanoic acid
OH
Impurity H (EP): 6-Methoxynaphthalen-2-ol
MM0152.14 5111-66-0 100mg
(Hydroxynerolin) O
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-424
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
OH
MM0152.14- Impurity H (EP): 6-Methoxynaphthalen-2-ol
5111-66-0 25mg
0025 (Hydroxynerolin) O
23981-47-7 25mg O
0025 yl)acetic Acid ( -Demethylnaproxen) O
Br
Br
MM0152.17-
Impurity N (EP): 2-Bromo-6-methoxynaphthalene 5111-65-9 25mg
0025 O
OH
MM0152.19 rac-Naproxen 23981-80-8 100mg O
O
MM0152.19- OH
rac-Naproxen 23981-80-8 25mg O
0025 O
O
MM0152.20 Naproxen Isopropyl Ester 156967-24-7 100mg O
O
MM0152.20- O
Naproxen Isopropyl Ester 156967-24-7 25mg O
0025 O
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-425
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
O OH
Naproxen 1,3-Butylene Glycol Esters (Mixture of Regio- and O
OH
MM0152.22- O
Naproxen 2,3-Butylene Glycol Ester n/a 25mg O
0025 O
OH
O
O
Naproxen 1,2-Propylene Glycol Esters (Mixture of Regio- and O
OH
O OH
O
Naproxen 1,2,3-Propanetriol Esters (Mixture of Regio- and O
OH
O OH
O
MM0152.24- Naproxen 1,2,3-Propanetriol Esters (Mixture of Regio- and O
n/a 25mg
0025 Stereoisomers) O
OH
O
O OH
MM0152.28- N
2-(6-Methoxy-2-naphthyl)acetonitrile 71056-96-7 25mg O
0025
Naratriptan Hydrochloride
H
N
H
N
H
N
3-(1-Methylpiperidin-4-yl)-1H-indole
MM0299.09 Related compound A (USP): 3-(1-Methylpiperidin-4-yl)-1H- 17403-07-5 100mg
indole
N
H
N
3-(1-Methylpiperidin-4-yl)-1H-indole
MM0299.09-
Related compound A (USP): 3-(1-Methylpiperidin-4-yl)-1H- 17403-07-5 25mg
0025
indole
N
H
N
N-Methyl-1H-indole-5-ethanesulfonamide (2-(1H-Indol-5-yl)- H
MM0299.10 98623-50-8 100mg N
S
N-methylethanesulfonamide) O O
H
N
MM0299.10- N-Methyl-1H-indole-5-ethanesulfonamide (2-(1H-Indol-5-yl)- H
98623-50-8 25mg N
S
0025 N-methylethanesulfonamide) O O
Nateglinide
O
H
N
MM0847.00 Nateglinide 105816-04-4 100mg O
OH
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-426
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
O
H
Impurity E (EP): N-[(trans-4-Ethylcyclohexyl)carbonyl]-D- N
OH
MM0847.04 105746-45-0 50mg
phenylalanine (Nateglinide Ethyl Analog) O
MM0847.09- (1-Methylethyl)cyclohexyl]carbonyl]-D-phenylalanyl-D- H
N
O
OH
n/a 25mg
0025 phenylalanine Dicyclohexylammonium Salt (Nateglinide IPP O
N
H
O
NH2
NH2
MM0314.03-
Phenylalanine 150-30-1 25mg OH
0025 O
O
H
MM0847.10- N
O
Nateglinide Methyl Ester 105746-47-2 25mg O
0025
O
H
MM0847.11- N
O
Nateglinide Isopropyl Ester n/a 25mg O
0025
Nebivolol Hydrochloride
AND Enantiomer
OH OH
Nebivolol Hydrochloride
H H H
O N O
O
MM0947.01- O
OH
6-Fluoro-3,4-dihydro-2H-1-benzopyran-2-carboxylic Acid 99199-60-7 25mg
0025 F
OH
MM0947.02- (1S,2R)-2-(2-Benzylamino-1-hydroxyethyl)-6-fluorochromane H H
N O
129050-27-7 25mg
0025 F
Nefazodone Hydrochloride
N
N N
O
N +
MM0591.02- N N
N N Cl
Nefazodone N-Oxide 2724726-95-6 25mg O
O
0025
Nefopam Hydrochloride
O
MM1189.00 Nefopam Hydrochloride 23327-57-3 100mg HCl
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-427
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
Neohesperidin-dihydrochalcone
OH
O O OH O
HO
HO O
O
OH
OH
O
OH
OH
Neostigmine Bromide
O
Neostigmine Metilsulfate
O O O
Nevirapine
N N N
MM1146.00-
Nevirapine Anhydrous 129618-40-2 250mg
0250
N
H
O
dipyrido[3,2-b:2',3'-e][1,4]diazepin-6-one
MM1146.02
Related compound B (USP): 5,11-Dihydro-4-methyl-6H-
287980-84-1 100mg
N
H
dipyrido[3,2-b:2',3'-e][1,4]diazepin-6-one O
Cl N
MM1146.04-
3-Amino-2-chloro-4-methylpyridine 133627-45-9 25mg
0025 H 2N
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-428
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
N Cl
Cl
2-Chloro-N-(2-chloro-4-methyl-3-pyridinyl)-3- H
N
MM1146.05 133627-46-0 100mg N
pyridinecarboxamide O
N Cl
Cl
MM1146.05- 2-Chloro-N-(2-chloro-4-methyl-3-pyridinyl)-3- H
N
133627-46-0 25mg N
0025 pyridinecarboxamide O
O
+
N N N
MM1146.06-
Nevirapine N10-Oxide 1027324-99-7 25mg
0025
N
H
O
O
+
N N N
MM1146.07-
Nevirapine N1-Oxide 162255-73-4 25mg
0025
N
H
O
Niaouli Oil
O
Nicardipine Hydrochloride
H
N
O O
N
+O
HCl
N
O
H
N
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-429
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
H
N
O O +
N
O O O
MM0465.04 Nicardipine N-Oxide n/a 100mg
+O
N
O
H
N
O O +
MM0465.04- N
O O O
Nicardipine N-Oxide n/a 25mg
0025 +O
N
O
Nicergoline
Br
H
N
MM0115.00-
Nicergoline 27848-84-6 250mg N
O
O N
0250 O
4,7-dimethyl-4,6,6a,7,8,9,10,10a-octahydro- N
N
O N
MM0115.02 38536-28-6 50mg
indolo[4,3-fg]quinolin-9-yl]methyl 5-Chloro- O
O
pyridine-3-carboxylate (Chloronicergoline)
Impurity C (EP): [(6aR,9R,10aS)-10a-Methoxy- H
N
4,7-dimethyl-4,6,6a,7,8,9,10,10a-octahydro- N
OH
MM0115.04 35155-28-3 100mg
indolo[4,3-fg]quinolin-9-yl]methanol O
(Methylmethoxylumilysergol)
Impurity C (EP): [(6aR,9R,10aS)-10a-Methoxy- H
N
MM0115.04- 4,7-dimethyl-4,6,6a,7,8,9,10,10a-octahydro- N
OH
35155-28-3 25mg
0025 indolo[4,3-fg]quinolin-9-yl]methanol O
(Methylmethoxylumilysergol)
Br
Br
O
H +
N
MM0115.09- N
Methylmethoxylumilysergol N-Oxide n/a 25mg OH
0025 O
Niclosamide
O
+
Cl N
O O
MM0361.00 Niclosamide 50-65-7 250mg Cl
N
H
OH
Nicoboxil
O
O
O N
MM3800.00 Nicoboxil 13912-80-6 100mg
Nicorandil
O
O +O
MM0924.00 Nicorandil 65141-46-0 100mg N
H
N
O
N
Nicotinaldehyde Thiosemicarbazone
H
N N H2
MM1801.00 Nicotinaldehyde Thiosemicarbazone 555-90-8 100mg N N
S
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-430
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
Nicotinamide (Niacinamide)
O
MM0552.00-
Nicotinamide 98-92-0 250mg N NH2
0250
O
MM0552.03- N
Impurity C (EP): Pyridine-2-carboxamide (Picolinamide) 1452-77-3 25mg NH2
0025
O
MM0552.02- Impurity E (EP): Pyridine-3-carboxamide 1-Oxide O +
1986-81-8 25mg N NH2
0025 (Nicotinamide N-Oxide)
O
MM0552.01-
Isonicotinamide 1453-82-3 25mg NH2
0025 N
O
+
MM0552.05 1-Methylnicotinamide Iodide 6456-44-6 100mg N NH2 I
O
MM0552.05- +
1-Methylnicotinamide Iodide 6456-44-6 25mg N NH2 I
0025
O
MM0553.00-
Nicotinic Acid 59-67-6 250mg N OH
0250
O
OH
MM0553.13 Nicotinuric Acid 583-08-4 100mg N N
H
O
O
MM0553.13- OH
Nicotinuric Acid 583-08-4 25mg N N
H
0025 O
O
MM0552.06-
N-Methylnicotinamide 114-33-0 25mg N N
0025 H
O
MM0552.07- N NH2
6-Aminonicotinamide 329-89-5 25mg
0025 H2 N
Nicotine
MM0517.00-
Nicotine [for single use] 54-11-5 100mg N N
100
OH O
N N HO H 2O
OH
MM1522.00 Nicotine Ditartrate Dihydrate 6019-06-3 250mg O OH
2
2
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-431
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
3-[(1S,2S)-1-Methyl-1-oxidopyrrolidin-2-yl]pyridine (Nicotine +
MM0517.08 51095-86-4 50mg N N
cis-N'-Oxide) O
N N O
MM0517.14 (5RS)-5-(Pyridin-3-yl)pyrrolidin-2-one ((RS)-Norcotinine) 17708-87-1 100mg H
MM0517.14- N N O
(5RS)-5-(Pyridin-3-yl)pyrrolidin-2-one ((RS)-Norcotinine) 17708-87-1 25mg H
0025
MM0517.15- N
3-(1H-Pyrrol-2-yl)pyridine (ß-Nornicotyrine) 494-98-4 25mg N
0025 H
N
MM0517.16 (RS)-1-Methyl-3-nicotinoylpyrrolidine ((RS)-MNP) 125630-26-4 100mg
N
O
H
Pseudooxynicotine Dihydrochloride (4-(Methylamino)-1-(3- N
N
HCl
MM0517.17 66093-90-1 100mg 2
pyridyl)butan-1-one Dihydrochloride)
O
MM0517.17- H
Pseudooxynicotine Dihydrochloride (4-(Methylamino)-1-(3- N
N
HCl
66093-90-1 25mg 2
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-432
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
Mixed
(1RS,2S)-Nicotine N,N'-Dioxide (3-[(1RS,2S)-1-Methyl-1- O &1
MM0517.19 2055-29-0 100mg + +
N N
oxidopyrrolidin-2-yl]pyridine 1-Oxide)
O
O OH
OH
2
H 2O
2
O
MM0553.05- Impurity A (EP): 6-Methylpyridine-3-carboxylic Acid (6-
3222-47-7 25mg N OH
0025 Methylnicotinic Acid)
N OH
Impurity B (EP): 2,2'-Bipyridine-5,5'-dicarboxylic
MM0553.06 1802-30-8 100mg
Acid (6,6'-Dinicotinic Acid) HO N
N OH
MM0553.06- Impurity B (EP): 2,2'-Bipyridine-5,5'-dicarboxylic
1802-30-8 25mg
0025 Acid (6,6'-Dinicotinic Acid) HO N
MM0553.07- N
Impurity C (EP): 5-Ethyl-2-methylpyridine 104-90-5 100mg
0100
O
MM0553.08- N OH
Impurity D (EP): Pyridine-2,5-dicarboxylic Acid 100-26-5 25mg HO
0025
O
N
Impurity E (EP): Pyridine-4-carboxylic Acid OH
MM0553.03 55-22-1 100mg
(Isonicotinic Acid)
O
N
MM0553.03- Impurity E (EP): Pyridine-4-carboxylic Acid OH
55-22-1 25mg
0025 (Isonicotinic Acid)
O
O
+
N
MM0553.11 Impurity H (EP): 3-Nitropyridine 2530-26-9 100mg N O
O
+
MM0553.11- N
Impurity H (EP): 3-Nitropyridine 2530-26-9 25mg N O
0025
O
+
N
N O
MM0553.12-
Impurity I (EP): 3,5-Dinitropyridine 940-06-7 25mg
0025
+
N
O O
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-433
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
O
OH
MM0553.13 Nicotinuric Acid 583-08-4 100mg N N
H
O
O
MM0553.13- OH
Nicotinuric Acid 583-08-4 25mg N N
H
0025 O
O
MM0533.02-
Isopropyl Nicotinate 553-60-6 100mg N O
0100
MM0553.14- N
3-Ethylpyridine 536-78-7 100mg
0100
HO
O
MM0553.15- N OH
6-Hydroxynicotinic Acid 5006-66-6 25mg
0025
HO
Nifedipine
H
N
O O
MM0003.00-
Nifedipine 21829-25-4 250mg O O
O
+
0250 N
O
O
Impurity C (EP) as E/Z-Mixture: Methyl (E/Z)-2-(2- O
MM0003.07 39562-27-1 100mg +
Nitrobenzylidene)-3-oxobutanoate O N
O
O
MM0003.07- Impurity C (EP) as E/Z-Mixture: Methyl (E/Z)-2-(2- O
39562-27-1 25mg +
0025 Nitrobenzylidene)-3-oxobutanoate O N
O
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-434
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
H 2N
H 2N
MM0003.08-
Impurity D (EP): Methyl 3-Aminobut-2-enoate 14205-39-1 25mg O
0025
O
O
O
+
N
MM0003.03 2-Nitrobenzaldehyde 552-89-6 100mg O
O
O
+
MM0003.03- N
2-Nitrobenzaldehyde 552-89-6 25mg O
0025
N
O
2-Hydroxymethyl-5-(methoxycarbonyl)-6-methyl-4-(2- O
MM0003.06- O O
nitrophenyl)pyridine-3-carboxylic Acid Lactone (Hydroxy 34785-00-7 25mg O
+
0025 N
O
Dehydro Nifedipine Lactone)
O O
MM0003.10-
Methyl Acetoacetate 105-45-3 100mg
0100 O
H
N
O O
Dimethyl 2,6-Dimethyl-4-(3-nitrophenyl)-1,4-dihydropyridine-
MM0092.01 21881-77-6 100mg O O
3,5-dicarboxylate (m-Nifedipine) O
+
N
O
H
N
O O
MM0092.01- Dimethyl 2,6-Dimethyl-4-(3-nitrophenyl)-1,4-dihydropyridine-
21881-77-6 25mg O O
0025 3,5-dicarboxylate (m-Nifedipine)
+ O
N
O
Niflumic Acid
F F
OH
N Cl
N Cl
N OH
F F
Impurity B (EP): 2-Hydroxy-N-[3-(trifluoro- H
N
MM0850.05 72633-64-8 100mg F
methyl)phenyl]pyridine-3-carboxamide O
N OH
F F
MM0850.05- Impurity B (EP): 2-Hydroxy-N-[3-(trifluoro- H
N
72633-64-8 25mg F
0025 methyl)phenyl]pyridine-3-carboxamide O
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-435
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
F F
F
MM0161.06 Impurity C (EP): 3-(Trifluoromethyl)aniline 98-16-8 100mg
N H2
F F
F F
F F
MM0850.02-
Niflumic Acid Isopropyl Ester n/a 25mg N NH
0025
O
F F
MM0850.09-
Niflumic Acid Ethyl Ester 51703-19-6 25mg N NH
0025
O
Nifuratel
O
O
O
MM1021.00 Nifuratel 4936-47-4 50mg O
N
+ O
N
N
S
Nifuroxazide
OH
MM0574.00- O
H
Nifuroxazide 965-52-6 250mg O
N
+ O
N
N
O
0250
OH
Impurity A (EP): 4-Hydroxybenzohydrazide H
N
MM0574.01 5351-23-5 100mg H 2N
(p-Hydroxybenzohydrazide) O
OH
MM0574.01- Impurity A (EP): 4-Hydroxybenzohydrazide H
N
5351-23-5 25mg H 2N
0025 (p-Hydroxybenzohydrazide) O
O
MM0431.00- Impurity B (EP): Methyl 4-Hydroxybenzoate (Methyl O
99-76-3 250mg
0250 Parahydroxybenzoate)
HO
ISO 17034 | ISO 17025 | Edition 01/2023 | Visit us at lgcstandards.com/mikromol or email to mikromol@lgcgroup.com A-436
Pharmaceutical APIs and impurities
Product Code Product CAS No. CS Unit
Nifursol
O
O OH O +
+ N
N N
O N O O