Issue 2 • 2016

Reference Materials for

Jet Fuel Analysis
Discover the Comprehensive Product Range of
Paragon Scientific Ltd

pg. 3

Hexabromocyclododecane Standards
New Certified Indoor Air Calibration Set
New Analytical Standard for Vincamine
Drug Interference Mixes
New European Reference Materials (ERMs) on the Market
Feature Article CRMs for Jet Fuel Testing from Paragon Scientific Ltd
3 Reference Materials for Jet Fuel Analysis
Discover the Comprehensive Product Range of
Paragon Scientific Ltd
Dr. Matthias Nold
Standards
6 Hexabromocyclododecane Standards
New Analytical Standards for the Main Diastreomers of HBCD
8 New Certified Indoor Air Calibration Set Dear Customer,
Offers Increased Component Stability for Indoor Air Analysis In order to offer you the most comprehensive choice of analytical
10 New Certified Reference Materials for ICH Q3D, standards and certified reference materials on the market, our
USP and Ph. Eur. 5.20 product range has been greatly expanded over the years. With
TraceCERT® ICP Solution Mixes for numerous ISO/IEC 17025 and ISO Guide 34 accredited sites, we
Elemental Impurities Testing have immense in-house knowledge of the manufacturing of
12 Trusting Your Results Means Trusting certified reference materials, reflected by a number of well-known
Your Reference Material brands such as Cerilliant, TraceCERT® and Supelco.
New Product Additional to the Organic TraceCERT® In addition, we also make standards and certified reference materials
CRM Portfolio
of renowned third party suppliers, such as pharmacopoeias (USP, PhEur) or metrological
13 New Analytical Standard for Vincamine institutes (IRMM, NIST, NRC), easily available to you through our ordering system.
…and Other Additions to the Phytochemical Standards Range
We are proud to include the products of UKAS-accredited CRM manufacturer Paragon
14 Drug Interference Mixes Scientific as part of our offering. Paragon Scientific Ltd has more than two decades of
Certified Reference Solutions for Interference Testing experience in the production and certification of certified reference materials for the
17 The New IC Group of High-Quality IC-Certified petrochemical industry. In the feature article of this issue of Analytix, Paul Whitehurst
Reference Standards from Paragon Scientific Ltd will provide valuable insight into certified reference materials
IC TraceCERT® Carbohydrates and Sugar Alcohols for jet fuel testing. I also invite you to read the other articles of this issue to familiarize
yourself with our broad comprehensive product offerings of analytical reagents,
Labware standards and certified reference materials.
18 NEW Timestrip® Indicators
The Smart Way to Measure Time and Temperature

NPC With kind regards,

19 New European Reference Materials (ERMs)
on the Market
The IRMM has Released New CRMs for a Specific
Cancer Marker and Radioactivity in Food
21 NIST Standard Reference Materials®
of Ferrous Metals
More than 100 new SRMs for steel, alloy,
and cast iron analysis are available now. Dr. Matthias Nold
Senior Product Manager Analytical Standards
matthias.nold@sial.com

Analytix is published five times per year by Sigma-Aldrich Chemie GmbH,

Industriestrasse 25, CH-9471 Buchs SG, Switzerland.
Sigma-Aldrich Corp. is a subsidiary of Merck KGaA, Darmstadt, Germany.
Publisher: Sigma-Aldrich Marketing Operations Europe
Editor: Daniel Vogler

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Feature Article 3

Reference Materials for Jet Fuel Analysis

Discover the Comprehensive Product Range of Paragon Scientific Ltd

Paul Whitehurst, Paragon Scientific Ltd

pw@paragon-sci.com
Paragon Scientific is a recognized expert in the production of
premium quality Calibration Standards and Certified Reference
Materials (CRMs), as demonstrated by their ISO Guide 34 and
ISO/IIEC 17025 accreditations from UKAS (The United Kingdom
The Aniline Point Certified Reference Material listed below is for the
Accreditation Service).
calibration and verification of measuring equipment used in testing
As part of their commitment to continually developing products and petroleum and derivative products for aniline point according to
remaining at the forefront of the analytical industry, Paragon Scientific ASTM D611, IP 2, and ISO 2977, and is certified under ISO Guide 34
has developed a range of Calibration Standards and Certified Reference accreditation.
Materials specifically manufactured and certified for use in the analysis
and testing of jet fuel. These products cover many of the property Cat. No. Test Method Certified Value Package Size
characteristics required for jet fuel analysis, as specified in world jet CRMUAPKR ASTM D611, IP 2, 58.48 °C 250 mL
fuel specifications by issuing agencies (for example, Jointly Operated ISO 2977
Systems (AFQRJOS), ASTM Standard Specification ASTM D1655,
British Ministry of Defense Standard DEF-STAN, the International Air Color Reference Standards
Transportation Association (IATA) and engine manufacturers, etc). The color of jet fuel serves as an indicator of product quality and
Jet fuel analysis depends on credible test data needed to monitor jet processing performance throughout the industry. Therefore, the
fuel composition, volatility, fluidity, combustion, corrosion, thermal determination of color is important for quality control purposes, to
stability, contaminants, additives and other groups of characteristics. check for any contamination or degradation. Darkening of the fuel or
The quality of the test data is only as good as the Calibration Standard a change of color may indicate that the fuel has been contaminated
or Certified Reference Material used to calibrate/verify the measuring and is out of specification.
equipment.
Paragon Scientific’s premium Calibration Standards and Certified
Reference Materials are intended for analytical and testing laboratories
to calibrate/verify measuring equipment, evaluate test procedures,
and for quality control purposes for many of the jet fuel property
characteristics such as Aniline Point, Color, Density, Distillation, FIA
Aromatics, Flash Point, Freezing Point, Smoke Point, Sulfur, Total Acidity
and Viscosity.

Paragon Scientific offers Saybolt Color standards, ideal for validating

the appearance of jet fuel. The Calibration Standards listed below are
Aniline Point Certified Reference Material
for routine calibration of color measuring equipment and verification
Determining the aniline point is useful in characterizing pure of test data, and are certified under ISO/IEC 17025 and
hydrocarbons and in analyzing hydrocarbon mixtures. It is particularly ISO Guide 34 accreditation.
informative when used in combination with other physical properties,
as the aniline point serves to provide an estimate of the aromatic
hydrocarbon content of mixtures.

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4 Analytix | 2: 2016

Cat. No. Test Method Certified Value Package Size measurements can indicate the possible presence of highly volatile
134040 ASTM D6045, D156 -10 500 mL and flammable materials in a relatively non-volatile or non-flammable
material. An abnormally low flash point on a sample of kerosene
134050 ASTM D6045, D156 0 500 mL
could indicate a contamination of the product.
134060 ASTM D6045, D156 +12 500 mL
134070 ASTM D6045, D156 +25 500 mL
Paragon Scientific offers a range of primary Flash Point Certified
Reference Materials for the verification of laboratory instruments used
Density Certified Reference Material in testing petroleum and derivative products for flash point according
The determination of density is a fundamental property measurement, to IP 170, ISO 13736 and ASTM D56. These products are certified
particularly in regard to characterizing both light and heavy petroleum under ISO Guide 34 accreditation.
products. Determination of the density or relative density of petroleum Cat. No. Test Method Certified Value Package Size
and its products is necessary for the conversion of measured volumes CRMU-ABKR Abel Flash IP 170, 41.2 °C 250 mL
to volumes at the standard temperature of 15 °C, which is standard ISO 13736
practice throughout the petroleum industry. CRMU-TAKR TAG Flash ASTM D56 40.4 °C 250 mL
The Density Certified Reference Material listed below is for the
verification of laboratory equipment used in testing petroleum and Freezing Point Certified Reference Material
derivative products for density according to ASTM D4052, IP 365, Maximum freezing point values are set for all aviation fuels as a guide
and ISO 12185. This product is certified under ISO/IEC 17025 and to the lowest temperatures at which the fuel can be used without the
ISO Guide 34 accreditation. risk of solidified hydrocarbon crystals forming. Verifying the freezing
Cat. No. Test Method Certified Value Package Size
point of jet fuel is fundamental for use throughout the industry, since
the presence of hydrocarbon crystals could lead to fuel starvation
CRMUDEKR ASTM D4052, IP 365, 0.79672 g/mL 250 mL
ISO 12185
through clogged fuel lines or filters.
Freezing Point Certified Reference Materials from Paragon Scientific
Distillation Certified Reference Material are ideal for the verification of laboratory instruments used in testing
The distillation range of jet fuel is an important quality characteristic, petroleum and derivative products for freezing point according to
particularly in providing information on safety and performance of ASTM D2386 and IP 16. This product is certified under ISO Guide 34
the material, as well as insight into the composition and behavior of accreditation.
the fuel during storage and use. Cat. No. Test Method Certified Value Package Size
The Distillation Certified Reference Material listed below is for the CRMU-FRKR ASTM D2386, IP 16 -53.4 °C 250 mL
verification of laboratory instruments used in testing petroleum and
derivative products for Distillation according to ASTM D86, IP 123, and Mercaptan Sulfur Certified Reference Material
ISO 3405. This product is certified under ISO Guide 34 accreditation. Determination of the sulfur content of jet aviation fuel is an important
Cat. No. Test Method Certified Value Package Size quality characteristic, particularly for the use of manufacturing control
CRMUDIKR ASTM D86, IP 123, 148.1 °C – 260.3 °C 250 mL
purposes. Mercaptan sulfur has notable traits which need to be
ISO 3405 mitigated, including: an objectionable odor, an adverse effect on fuel
system elastomers, and a tendency to be corrosive to fuel system
FIA Aromatics Certified Reference Material components.
Information on aromatic hydrocarbon types is an important quality Paragon Scientific offers a Certified Reference Material for the
characteristic of jet fuel, particularly in the refinery and manufacturing calibration and verification of laboratory instruments used in testing
processes. This analysis is not only useful for indicating the quality of jet petroleum, and derivative products for mercaptan sulfur content
fuel overall, but is also useful in characterizing the quality of petroleum according to ASTM D3227, IP 342, and ISO 3012. This product is
fractions as blending components for motor and aviation fuels. certified under ISO Guide 34 accreditation.
Paragon can offer an ISO Guide 34 FIA Aromatics Certified Reference Cat. No. Test Method Certified Value Package Size
Material for the calibration and verification of laboratory instruments CRMUSUKR ASTM D3227, IP 342, 0.00093 % wt 250 mL
used in testing petroleum and derivative products for Hydrocarbon ISO 3012
Types in Liquid Petroleum Products by Fluorescent Indicator Adsorption
according to ASTM D1319 and IP 156. This product is certified under Total Acidity Certified Reference Material
ISO Guide 34 accreditation. The level of acidity is an important characteristic in the composition
Cat. No. Test Method Certified Value Package Size of jet fuel. Some acids can be naturally occurring in aviation turbine
CRMU-FIKR ASTM D1319, IP 156 16.53% Volume 250 mL
fuels or are present due to acid treatment during the refinery process.
While significant acid contamination is unlikely, due to the number of
Flash Point Certified Reference Materials checks that occur throughout the refining process, trace amounts of
Flash point is one of a number of properties that must be considered acid may be present and are undesirable as they may cause corrosion
in assessing the overall flammability hazard of a material and is of of the metal parts the fuel comes into contact with or impair the
particular importance in shipping and safety regulations. Flash point water separation characteristics of the fuel.

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Feature
Standards
Article 5

As part of Paragon Scientific’s Fuels Testing range, the Certified

Reference Material listed below is for the calibration and verification
of laboratory instruments used in testing petroleum and derivative
products for acidity in turbine engine fuel according to ASTM D3242
and IP 354. This product is certified under ISO Guide 34 accreditation.
Cat. No. Test Method Certified Value Package Size
CRMUADKR ASTM D3242, IP 354 0.0083 mg KOH/g 250 mL

Smoke Point Certified Reference Material

Determination of the smoke point of jet aviation fuel is an important
quality characteristic. Generally, a fuel with high aromatic content
emits a smokier flame, and a high smoke point material means that
the fuel will have a low smoke-producing tendency.
As part of Paragon Scientific’s Fuels Testing range, the Certified
Reference Material listed below is for the calibration and verification
of laboratory instruments used in testing petroleum and derivative
products for smoke point according to ASTM D1322, IP 57, IP 598, and
ISO 3014. This product is certified under ISO Guide 34 accreditation.
Cat. No. Test Method Certified Value Package Size
CRMUSPKR ASTM D1322, IP 57, 24.25 mm 250 mL
IP 598, ISO 3014

Viscosity Standards In regard to the measurement of jet fuel, low-temperature viscosity

In order to provide traceability for a viscosity measurement, Viscosity standards will be most applicable to the verification of jet fuel viscosity
Standards play a crucial role in determining accurate results. These measurements. Paragon Scientific’s low-temperature viscosity standards
standards are used to verify a viscometer’s constant. The determination are for the verification of glass capillary viscometers and other viscosity
of kinematic viscosity is an important property, primarily for safety measuring equipment where operating temperature is controlled
reasons. If the fuel’s viscosity is too high then the spray droplets, when precisely – ideal for the analysis of jet fuel. These products are certified
injected into the combustion section of the engine, will not be fine under ISO 17025 and ISO Guide 34 accreditation.
enough, causing problems when re-lighting the engine when in flight.

Cat. No. Test Method -20 °C Kinematic Viscosity mm2/s (cSt) -40 °C Kinematic Viscosity mm2/s (cSt) Package Size
JF1L ASTM D445, IP71 Section 1, ISO 3104 3.727 7.186 500 mL
JF1H ASTM D445, IP71 Section 1, ISO 3104 5.766 13.02 500 mL

Please note: certified values stated are nominal and can vary from batch to batch.

Why Choose Paragon Scientific? All of Paragon’s products have been manufactured to the highest
High quality Calibration Standards and Certified Reference Materials certified integrity and premium quality on a global level. Every
are only available from organizations with a robust quality system certificate provides the lowest level of uncertainty of measurement
such as Paragon Scientific. ISO/IEC 17025 and ISO Guide 34 and is fully traceable to international methodology. With an excellent
accreditation, also called the “Gold Standard”, provides credibility to reputation across the industry, Paragon provides excellent customer
the production and testing of Certified Reference Materials (CRMs) service, technical support, and prompt delivery to all its customers.
by the producer. In addition, the end users can be confident that The complete Paragon Scientific product line of Calibration Standards
they can rely upon the Certified Reference Material for accurate and and Certified Reference Materials is available from Sigma-Aldrich and
reliable measurement results. includes over 600 products such as Viscosity Standards, Viscometers,
Paragon Scientific produces the most highly accredited Calibration Density Standards, Flash Point Standards, Total Acid Number (TAN)
Standards and Certified Reference Materials, in many cases under Standards, Total Base Number (TBN) Standards, Color Standards, and
dual accreditation from UKAS in accordance with ISO 17025 and Distillation Standards, among others.
ISO Guide 34. For the complete portfolio, visit our website at
sigma-aldrich.com/paragon

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6 Analytix | 2: 2016

Hexabromocyclododecane Standards
New Analytical Standards for the Main Diastreomers of HBCD

Matthias Nold, Product Manager Analytical Standards

matthias.nold@sial.com
The brominated flame retardant hexabromocyclododecane (HBCD)
has been widely used in industry, mainly in thermal insulation
polystyrene foams and textile coatings. In addition to being present
in huge quantities in many buildings, the compound is also released
into the environment and can be found in biological samples
throughout the world. An EU risk assessment came to the conclusion
that HBCD has PBT (persistent, bioaccumulative and toxic) properties.
As a consequence, it was decided to include HBCD in REACH
Annex XIV as an SVHC (substance of very high concern). Since the
so-called “sunset date” of August 21, 2015, HBCD is only permitted
for authorized applications in the European Union. In addition,
since 2013, the compound has been included in Annex A of the
Stockholm Convention on Persistent Organic Pollutants (POPs). The
U.S. Environmental Protection Agency (EPA) has also classified HBCD
as a chemical of concern. In Japan, the compound has been banned
from importation and production since 2014. Despite the restrictions
on HBCD, it will still take several years until it is fully replaced by
alternative flame retardants, and it will still be present in existing
buildings, so monitoring of the compound in industrial goods and in
the environment will be necessary. Thus, reliable reference standards
are needed.
Cat. No. Description Package Size
There are sixteen possible stereoisomers of HBCD, but in the technical 51691 Hexabromocyclododecane 50 mg
mixture, the three isomers α, β and γ hexabromocyclododecane are (mixture of isomers)
predominantly present. The three isomers have different biological 30373 (±)-α-Hexabromocyclododecane 25 mg
activities. We offer analytical chromatography standards for all three
01986 (±)-β-Hexabromocyclododecane 25 mg
isomers as well as for the technical mixture of isomers (see Figure 1
73709 (±)-γ-Hexabromocyclododecane 25 mg
and Table 1).
Table 1. Main Stereoisomers of Hexabromocyclododecane.

In addition to these four HBCD standards, we offer an extensive range

Br Br Br Br
of standards and certified reference materials for substances of very
Br Br high concern. There are currently twelve TraceCERT® CRMs for SVHCs
available, manufactured under ISO/IEC 17025 and ISO Guide 34 double
Br Br accreditation and certified by quantitative NMR (qNMR) (see also
page 12). These products are marked with an asterisk in Table 2. The
Br Br Br Br table shows all TraceCERT CRMs as well as new additions of analytical
standards for SVHCs.
(±)-α-Hexabromocyclododecane (±)-γ-Hexabromocyclododecane
You can find an up-to-date list of standards and CRMs for SVHCs on
the web at sigma-aldrich.com/svhc
Br Br
Br

Br
Br Br

(±)-β-Hexabromocyclododecane

Figure 1. The Three Main Isomers of Hexabromocyclododecane.

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Feature
Standards
Article 7

Package
Cat. No. Description Comment Size
NEW! 08267* Acrylamide Candidate List 100 mg
07671* Anthracene Candidate List 100 mg
79997 Azodicarboxamide Candidate List 50 mg
42438* Benzyl butyl phthalate BBP Latest application date: 08/21/2013; Sunset date: 02/21/2015 50 mg
67261* Bis (2-ethyl(hexyl)phthalate) (DEHP) Latest application date: 08/21/2013; Sunset date: 02/21/2015 100 mg
NEW! 18139* 4,4'-Diaminodiphenylmethane Latest application date: 02/21/2013; Sunset date: 08/21/2014 50 mg
18281* Dibutylphthalat (DBP) Latest application date: 08/21/2013; Sunset date: 02/21/2015 50 mg
59832* Dipentyl phthalate (DPP) Candidate List 50 mg
43540* Diisobutyl phthalate (DIBP) Candidate List 100 mg
01913* 2-Ethoxyethyl acetate Candidate List 100 mg
NEW! 80444 Heneicosafluoroundecanoic acid Candidate List 50 mg
08483 Hexahydro-4-methylphthalic anhydride, mixture of cis and trans Candidate List 50 mg
NEW! 08485 Methoxyacetic acid Candidate List 100 mg
56614* Michler’s ketone Candidate List 100 mg
06084 Nitrobenzene Candidate List 1mL
NEW! 04029* 4-Nonylphenol Candidate List 50 mg
47794 1,2,3-Trichloropropane Candidate List 100 mg
96382* Tris(2-chloroethyl) phosphate Candidate List 100 mg
Table 2. Selection of Analytical Standards and CRMs (marked with *) for ECHA Substances of Very High Concern.

For a complete list, please visit sigma-aldrich.com/svhc

Are You Familiar

with Our IR Product Line
from Specac®?
We offer products for high performance
measurements within IR spectroscopy.
Our selection includes:
• Quest™ and Golden Gate™ ATR units and
dedicated supplies
• IR liquid sample cells and parts
• Lab pellet presses
• Film makers

For up-to-date product information,

please visit sigma-aldrich.com/specac

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8 Analytix | 2: 2016

New Certified Indoor Air Calibration Set

Offers Increased Component Stability for Indoor Air Analysis

Philip Pryor, Scientist R&D One new indoor air standard (40353-U) is unique due to the
philip.pryor@sial.com combination of several diverse functional groups in solution. This
Kathleen Kiefer, Senior Scientist R&D calibration standard was initially prepared in a methanol:water (97:3)
kathy.keifer@sial.com solvent system. Long-term real-time stability data indicated this
Indoor air pollution is a term often used to describe organic chemicals formulation to be unstable. Due to excess methanol, a nucleophilic
that are released as gases (volatile organic compounds- VOCs) from reaction occurred with nonanal and decanal, to form acetal by-
certain solids or liquids. VOCs are carbon-based compounds that products as shown in Figure 1.
evaporate at room temperature. They may or may not have an odor. These reactions occurred during long-term storage and indicated
Indoor air pollution may be present in any building or home. The that the mixture needed to be reformulated. The new standard
sources for this poor air quality include the combustion of oil, gas, consists of a two-part set. The set is composed of a 48-component
kerosene, coal, wood, tobacco products, building materials and primary solution and a two-component secondary mix of ethyl
furnishings, and household cleaning and maintenance products. Some and butyl acetate in acetonitrile. The primary solution solvent
examples of the VOCs present in buildings and homes are: acetone, percentage was modified to methanol:water (95:5) and a proprietary
benzene, dichloromethane, toluene, and xylene. Concentrations in stabilizing agent was added. Stability is enhanced by the water
the air of these VOCs are often higher in buildings and homes than acting as both an acid and base which forms a methoxide anion.
occurs outdoors. The water molecules protonate the methoxide anion and extinguish
This poor air quality may have adverse effects on human health and the reaction before the process of acetal formation can begin. The
is known as sick building syndrome. Sick building syndrome is when proprietary stabilizer and water also inhibit the formation of C9 and
the occupants of a building or home experience health issues that C10 acetals. However, it is important to note that if the standard is
correlate to the time spent in the building. Long- and short-term stored above 40 °C, heat catalysis will be capable of inducing acetal
exposure to VOCs may lead to increased health risks. Due to these formation. The standards must be stored at the recommended
potential health issues, guidelines and target compound lists have temperature to reach the indicated shelf-life.
been developed for methods TO-14, TO-15, and TO-17. Our indoor air standards are all certified according to ISO/IEC 17025
In response to the growing health concerns of indoor air pollution, we and Guide 34 in a double-accredited laboratory. Products 40353-U
have has developed a number of indoor air calibration standards. The and 4M7537-U are validated by GC/MS while 40369-U is validated
analytical values for these certified reference materials are derived from by capillary GC/FID. Certificates for these products include a value
rigorous calculations for each component (homogeneity, concentration for the gravimetric concentration, analytical concentration, and
determination, and stability assessment) to verify concentration and expanded uncertainty for each analyte. These standards provide the
shelf-life. essential traceability required for quantitative measurements and
enable analysts to demonstrate the accuracy of their results, execute
instrument calibration, or verify their method requirements.

O CH3OH H3CO OCH3

R H -H2O R H

Figure 1. Reaction of Analytes with Methanol:Water (97:3).

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Feature
Standards
Article 9

Cat. No. Description Composition Concentration Package Size

40353-U 40-Component Indoor 1000 μg/mL in methanol: 1×1 mL
Air Standard water (95:5)
Acetone Ethanol 2-Propanol
Benzene 2-Ethyltoluene Styrene
Bromodichloromethane 3 Ethyltoluene Tetrachloroethylene
1-Butanol 4-Ethyltolutene Tetradecane
2-Butanone Heptane 1,2,4,5-Tetramethylbenzene
Chloroform Hexane Toluene
Dibromochloromethane Hexadecane Trichloroethylene
Decane (R)-(+)-Limonene Tridecane
Decanal 4-Methyl-2-pentanone 1,2,3-Trimethylbenzene
1,4-Dichlorobenzene Nonanal 1,2,4-Trimethylbenzene
1,2- Dichloroethane Nonane 1.3.5-Trimethylbenzene
Dichloromethane Octane 2,2,4-Trimethylpentane
1,2-Dichloropropane Pentadecane Undecane
2,4- Dimethylpentane (1S)--α Pinene o-Xylene
Dodecane (-)-β-Pinene m-Xylene
Ethylbenzene 1-Propanol p-Xylene
40369-U Ethyl Acetate/Butyl Acetate 1000 μg/mL in Acetone 1×1 mL
Solution
Ethyl Acetate
Butyl Acetate
40397-U Indoor Air Calibration Set 1000 μg/mL in Acetonitrile 2×1 mL
40353-U 48-component Indoor
Air Standard
40369-U Ethyl Acetate/Butyl
Acetate Solution

New Certified
Reference Materials
for Marine Biotoxins
Manufactured by the
National Research
Council of Canada (NRC)
Provided as CRM Solutions
or Matrix Materials

For more information, visit

sigma-aldrich.com/marinetoxins

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10 Analytix | 2: 2016

New Certified Reference Materials for ICH Q3D, USP

and Ph. Eur. 5.20
TraceCERT® ICP Solution Mixes for Elemental Impurities Testing

Matthias Nold, Product Manager Analytical Standards (Q3D) published by the Conference on Harmonization (ICH) in
matthias.nold@sial.com December 2014 as “step 4”. 1
Pharmaceutical products may be contaminated by elemental In the ICH Q3D guideline, every listed element has been assigned a
impurities, such as residues of reagents used in their synthesis or class – 1, 2A, 2B or 3 – based on its toxicity. Also taken into account
by contamination during their processing. Therefore, elemental is the type of patient exposure to the drug (oral, parenteral or by
impurities need to be monitored. Currently, the corresponding inhalation) and whether the element was intentionally added during
pharmacopoeia chapters (USP 232 and Ph. Eur. 5.20) are being revised drug production. In this case, a risk assessment is needed.
based on harmonization with the Guideline for Elemental Impurities
Parental Exposure Concentration

Elemental Impurities Mix Elemental Impurities Mix

Single-element CRM Solutions
Inhalation Exposure (in mg/kg)

according to ICH Q3D oral according to ICH Q3D parenteral (new)

ICH Q3D1

Limits

Standard 1 Standard 2 Standard 3 Standard 1 Standard 2 Standard 3 1 mg/L 1000 10,000

Element

ICH Q3D Class

Oral Exposure

Cat. No. Cat. No. Cat. No. Cat. No. Cat. No. Cat. No. each mg/L mg/L
19041 73108 69729 89118 89922 07368 each each
in 12% in 10% in 5% HNO3 in 12% HNO3 in 10% HCl in 5% HNO3
HNO3 hydrochloric and and
acid HF <0.5% <0.5% HF

Ag 2B 15 1 0.7 150 mg/L 10 mg/L 69389 12818 91543

As 1 1.5 1.5 0.2   15 mg/L 15 mg/L 75016 1969 67904
Au 2B 10 10 0.1 100 mg/L 100 mg/L – 38168 –
Ba 3 140 70 30   140 mg/L   70 mg/L 75017 59943 75187
Cd 1 0.5 0.2 0.2   5 mg/L   2 mg/L 12313 51994 90006
Co 2A 5 0.5 0.3   50 mg/L   5 mg/L 41798 30329 1488
Cr 3 1100 110 0.3 1100 mg/L 110 mg/L 72995 74582 93104
Cu 3 300 30 3   300 mg/L   30 mg/L 41621 68921 94459
Hg 1 3 0.3 0.1   30 mg/L   3 mg/L – 28941 75111
Ir 2B 10 1 0.1 100 mg/L   10 mg/L – – –
Li 3 55 25 2.5   55 mg/L   25 mg/L 39185 12292 90766
Mo 3 300 150 1   300 mg/L 150 mg/L 4488 68780 –
Ni 2A 20 2 0.5 200 mg/L 20 mg/L 72631 28944 19013
Os 2B 10 1 0.1 100 mg/L   10 mg/L – – –
Pb 1 0.5 0.5 0.5   5 mg/L   5 mg/L 75015 41318 39082
Pd 2B 10 1 0.1 100 mg/L   10 mg/L 42396 77091 50719
Pt 2B 10 1 0.1 100 mg/L   10 mg/L 49763 19078 74554
Rh 2B 10 1 0.1 100 mg/L   10 mg/L – 4736 –
Ru 2B 10 1 0.1 100 mg/L   10 mg/L – – –
Sb 3 120 9 2   120 mg/L   9 mg/L – 73495 91482
Se 2B 15 8 13 150 mg/L 80 mg/L 56544 50002 98838
Sn 3 600 60 6   600 mg/L   60 mg/L 63564 92615 42991
Tl 2B 0.8 0.8 0.8   8 mg/L   8 mg/L – 51873 5295
V 2A 10 1 0.1 100 mg/L 10 mg/L 75593 18399 44712
Table 1. Concentration Limits (in mg/kg) According to ICH Q3D and Suitable Multi-Element and Single-Element CRM Solutions

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Feature
Standards
Article 11

Most of the elements are also available as single-component solution

CRMS, which are also listed in Table 1.
All TraceCERT CRMs for ICP are characterized by the following
features:
• Unique level of accuracy and lot-specific values
• Produced in our double-accredited laboratory that fulfills
ISO/IEC 17025 and ISO Guide 34 and traceable to at least two
independent references (NIST, BAM or SI unit kg)
• Sophisticated packaging and comprehensive documentation,
including proper uncertainty calculation, expiration date and
storage information
• Packaged in opaque and gas-tight aluminum foil bags for extended
stability. Certificates are included and list up to 70 trace impurities
For more information and to view sample certificates, please visit
sigma-aldrich.com/inorganiccrm

References:
For each listed element, a level for the Permitted Daily Exposure (PDE) [1] ICH Q3D limits from Step 4 version, December 16th 2014 Option 1
is defined. (drug products with a daily dose ≤10 grams). USP and the European
Based on the PDE, the maximum content limits for drug products Pharmacopoeia commission have communicated that these limits will be
adopted in corresponding USP general chapter <232> and Ph. Eur. 5.20.
are calculated. This results in maximum levels allowed in a drug,
depending on the type of intake. Table 1 lists the corresponding
limits for each type of intake: oral, parenteral and inhalation. The
values are given in mg/kg and are valid for drug products with an
intake of ≤10 grams per day.
ICH Q3D does not include any recommendation on instrumental
methods to be used for monitoring the elements; however,
ICP-OES/MS and atomic absorption spectrometry (AAS) are certainly
the most common ones and are listed in both USP <233> and
Ph. Eur. 2.4.20 as suitable techniques.
Last summer, we launched three TraceCERT element mixes suitable for
calibration of ICP-OES, ICP-MS, or AAS instruments. The element ratios
correspond to the oral concentrations of the ICH Q3D guideline mix I
covers class 1, 2A and some of the 2B class elements; mix II covers the
remaining 2B class elements; and mix III covers all class 3 elements.
Due to big differences in the concentrations, it is not feasible to offer
all elements in a single mix.
Recently, we launched a second series of three mixes covering the
parenteral concentration ratios. The compositions of all six mixes
currently available are also listed in Table 1.

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12 Analytix | 2: 2016

Trusting Your Results Means Trusting

Your Reference Material
New Product Additions to the Organic TraceCERT® CRM Portfolio

Matthias Nold, Product Manager Analytical Standards An alternative to this laborious procedure is to use a direct relative
matthias.nold@sial.com method: a method where the chemical structure of the analyte has
Nowadays, the ISO/IEC 17025 accreditation has become almost no influence on the quantitative result. An example of an analytical
indispensable for analytical testing laboratories as proof of the method fulfilling this is quantitative nuclear magnetic resonance
competence of a laboratory. Customers, authorities, and other spectroscopy (qNMR). While NMR has been one of the most important
laboratories can trust the results of an accredited lab as being qualitative methods for structure elucidation of organic compounds for
reliable and comparable to values measured by other accredited labs the past 40 years, its quantitative use has gained increasing importance
worldwide. All aspects that are relevant to achieving reliable testing over the past decade. 2 It is currently a recognized and established
results, such as management system, method validation and training technique for quantification. The primary advantage of NMR is that
of the staff, are covered by ISO/IEC 17025.1 the signal integrals are only dependent on the number of atom
One very crucial aspect is the quality of the reference material used nuclei (in case of 1H-NMR protons) that lead to the signal. Therefore,
for calibration. ISO 17025 states that if possible, reference materials two completely different chemical molecules can be quantitatively
should be traceable to SI units or CRMs of internationally recognized compared with very high precision.
sources. In the past, the lack of availability of certified reference The Sigma-Aldrich Merck site in Buchs (Switzerland) achieved ISO/IEC
materials with this level of traceability led to a certain leniency on this 17025 accreditation for qNMR measurements in 2009. Measurement
point. However, as the number of available CRMs grows rapidly, we uncertainties down to 0.1% are achieved by this lab. 3 In combination
believe that in the coming years, auditors will increasingly bring this with ISO Guide 34, we are able to manufacture, under double
aspect into focus – only by using a truly traceable reference material accreditation, organic neat CRMs with traceability to NIST SRM. The
is a laboratory capable of generating traceable results. portfolio of organic TraceCERT products comprises over 250 products
However, the fact that most analytical techniques are structure- and continues to grow at a rapid pace. The portfolio comprises the
dependent makes the task of manufacturing traceable CRMs a very most commonly tested analytes in food and environmental analysis,
challenging one. For example, when using HPLC with UV, DAD, ranging from pesticides, PAHs, plasticizers, and fatty acids to amino
or Fluorescence detection, a traceable reference of the very same acids and natural products. The list below shows recent product
compound would always be needed. However, due to the infinite additions. A complete product listing can be found at
number of organic compounds, for most molecules, no reliable sigma-aldrich.com/organiccrm
reference material can be found. Therefore, the content of an organic
material is usually determined by measuring all potential impurities Cat. No. Description Package Size
(such as related compounds, water, residue solvents, and inorganic 43811 γ-Aminobutyric acid 50 mg
impurities) and calculating the content by subtracting the impurity 64148 Brombutid 50 mg
values from a total of 100%. With this method, if applied properly, 78567 Leucomalachite Green 100 mg
indirect traceability to SI can be achieved. However, it implies that no 16677 Metronidazole 50 mg
potential impurities have been overlooked and that related impurities 50550 Pyrocatechin 100 mg
measured by chromatographic method have the same response as 04029 4-tert-Octylphenol 50 mg
the target analyte.
87780 Solvent Yellow 124 25 mg
05099 Tricaprin 50 mg
Table 1. New product additions to the TraceCERT product range

CH3

N
CH3 O H3C O
H3C CH3
N
N N O CH3
H CH3
Br H3C CH3 H3 C
N N
CH3 CH3 CH3
Brombutid Leucomalachite Green Solvent Yellow 124

Figure 1. Selected Chemical Structures of new TraceCERT CRMs.

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Feature
Standards
Article 13

New Analytical Standard for Vincamine

…and Other Additions to the Phytochemical Standards Range

Matthias Nold, Product Manager Analytical Standards

matthias.nold@sial.com
The alkaloid Vincamine, constituent of the plant vinca minor, was first
isolated and described in the 1950s. It is commercially used as a drug
to increase blood flow and oxygen supply to the brain.
We recently introduced a new analytical standard for Vincamine.
The specification of this product includes, besides a chromatographic
purity, a quantitative NMR (qNMR) value.

H
N
N
OH
H3CO

O CH3
Vincamine

This product, along with the other new additions listed here, is
adding to the large portfolio of analytical standards and certified
reference materials for constituents of medicinal plants comprising
more than 600 products so far.
Cat. No. Description Package Size
You can find a complete listing of these products, including a list of
49975 Acacetin 10 mg
the most common medicinal plants and their active ingredients by
plant genus, on our website at sigma-aldrich.com/medicinalplants. 30729 2CR-Cinchonin 50 mg
You can also download or order a comprehensive brochure including 42866 Dihydromyricetin 10 mg
product listings and selected chromatographic applications. 42776 Ginsenoside Rh4 5 mg
55836 Quercetin 3-O-rutinoside-7-O-glucoside 10 mg
75778 Vincamine 50 mg
Table 1. New Analytical Standards of Active Ingredients and Marker
Substances for the Analysis of Herbal Medicinal Drugs.

Discover a New Class • Secondary standards manufactured by HWI Analytik

• Key components quantified traceable to primary
of Plant Extract pharmaceutical reference standards
(content assignment by qNMR)
Reference Materials • HPLC method and chromatogram with peak
assignment of components

Find products lists and an example certificate at

sigma-aldrich.com/plantextracts

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14 Analytix | 2: 2016

Drug Interference Mixes

Certified Reference Solutions for Interference Testing

Maximilian Magana, Technical Marketing Specialist

max_magana@cerilliant.com
Derrell Johnson, Manager, New Product Strategy and Tactical Marketing
derrell_johnson@cerilliant.com
Clinical Laboratory Improvement Amendments (CLIA) regulations
require manufacturers of diagnostics and laboratory-developed tests
(LDTs) to determine the effect of interfering substances during design,
method development ,and validation. 1, 3 The presence of interfering
substances, which often includes drugs and their metabolites,
impacts measurement accuracy of the analyte of interest. 1 Interfering
compounds originate from many sources, including sample matrices,
contaminants inadvertently introduced during handling or sample
preparation, or samples from patients on multiple drug regimens. 2, 3
The importance of identifying interfering substances is critical
for numerous testing applications ranging from therapeutic drug
monitoring, (confirmatory drug testing and forensic and toxicological
analysis) to pharmacokinetic studies and metabolomics. Interference
testing is performed during the development and validation Visit sigma-aldrich.com/cerilliant to view Cerilliant’s extensive
of analytical methods to eliminate inaccurate quantification or catalog offering of solution Certified Reference Materials.
misclassification/misidentification of target analytes. Register at sigma-aldrich.com/registercerilliant to receive news on
Cerilliant offers seven interference mixes containing more than the latest reference standards introduced by Cerilliant.
50 of the most routinely monitored over-the-counter (OTC) and
References:
prescription drugs. These mixes may be ordered separately or
[1] Burd EM. Validation of Laboratory-Developed Molecular Assays for Infectious
together as a kit for added convenience. Cerilliant’s drug interference
Diseases. Clin Microbiol Rev, 2010, 23(3), 550–576.
mixes are intended for qualitative use only in the evaluation of
[2] Krouwer JS. Interference Testing: Why Following Standards Is Not Always
interferences between the mix components and target analytes the Right Thing to Do. J Diabetes Sci Technol, 2012, 6(5), 1182–1184.
of interest in a testing laboratory’s analytical method. [3] McEnroe RJ, Burritt MF, Powers DM, Rheinheimer DW, Wallace BH. Interference
Testing in Clinical Chemistry; Approved Guideline—Second Edition. 2005,
25(27), 1–120.

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Feature
Standards
Article 15

Cerilliant® Drug Interference Mixes (For Qualitative Use Only)

Cat. No. Description
I-023 Drug Interference Mix 1
8 Components in Methanol, 1 mL/ampoule
Acetaminophen 1000 μg/mL Naproxen 1000 μg/mL
Caffeine 1000 μg/mL (-)-Nicotine 1000 μg/mL
(-)-Cotinine 1000 μg/mL Phentermine   100 μg/mL
Ibuprofen 1000 μg/mL R,R-(-)-Pseudoephedrine   100 μg/mL

I-024 Drug Interference Mix 2

5 Components in Methanol, 1 mL/ampoule
Gabapentin 100 μg/mL Valproic acid 100 μg/mL
Pregabalin 100 μg/mL Vigabatrin 100 μg/mL
Salicylic acid 100 μg/mL
I-025 Drug Interference Mix 3
6 Components in Acetonitrile, 1 mL/ampoule
Aripiprazole 100 μg/mL (+)-Propoxyphene   50 μg/mL
Lacosamide 100 μg/mL Rufinamide 100 μg/mL
Oxcarbazepine 100 μg/mL Warfarin 1000 μg/mL

I-026 Drug Interference Mix 4

12 Components in Methanol, 1 mL/ampoule
Alprazolam 100 μg/mL Fluconazole 100 μg/mL
Cimetidine 100 μg/mL Hydrochlorothiazide 100 μg/mL
Citalopram HBr 100 μg/mL (as free base) Lamotrigine 100 μg/mL
Clopidogrel bisulfate 100 μg/mL (as free base) Levothyroxine   5 μg/mL
Clonazepam 100 μg/mL Methylphenidate HCl 100 μg/mL (as free base)
Dextromethorphan   50 μg/mL Omeprazole 100 μg/mL

I-027 Drug Interference Mix 5

10 Components in Methanol, 1 mL/ampoule
Carbamazepine 100 μg/mL Phenytoin 100 μg/mL
Levetiracetam 100 μg/mL Sertraline HCl 100 μg/mL (as free base)
Metformin HCl 100 μg/mL (as free base) Topiramate 100 μg/mL
Phenobarbital 100 μg/mL Zolpidem tartrate 100 μg/mL
(R)-Phenylephrine HCl 100 μg/mL (as free base) Zonisamide 100 μg/mL
I-028 Drug Interference Mix 6
8 Components in Methanol, 1 mL/ampoule
Amlodipine besylate    5 μg/mL (as free base) Cetirizine diHCl   50 μg/mL (as free base)
Atorvastatin calcium salt 100 μg/mL (as free base) Dimenhydrinate 100 μg/mL
Azithromycin 100 μg/mL (as free base) Lisinopril 100 μg/mL (as free base)
Bupivacaine HCl 100 μg/mL (as free base) Loratidine 100 μg/mL

I-029 Drug Interference Mix 7

6 Components in Methanol, 1 mL/ampoule
Montelukast sodium 100 μg/mL (as free base) Prednisone   50 μg/mL
Pioglitazone HCl 100 μg/mL (as free base) Procainamide HCl 100 μg/mL (as free base)
Prednisolone 100 μg/mL Simvastatin 100 μg/mL

I-030 Drug Interference Mix Kit

1 ampoule of each of the listed standards
7 ampoules per kit
I-023 Drug Interference Mix 1
I-024 Drug Interference Mix 2
I-025 Drug Interference Mix 3
I-026 Drug Interference Mix 4
I-027 Drug Interference Mix 5
I-028 Drug Interference Mix 6
I-029 Drug Interference Mix 7

15
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16 Analytix | 2: 2016

Interested in Proficiency Testing (PT) or

External Quality Assessment (EQA)?

Pharmaceutical
PT Solutions

Visit our website

for the latest news
sigma-aldrich.com/pt

Interested in Proficiency Testing (PT) or

External Quality Assessment (EQA)?
Register today!

PT Reporting System

Register your laboratory,

submit your PT results,
manage your reports, and much more.
sigma-aldrich.com/pt

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Feature
Standards
Article 17

The New IC Group of High-Quality IC-Certified

Reference Standards
IC TraceCERT® Carbohydrates and Sugar Alcohols

Magdalena Ulman, Product Manager Analytical Reagents

magdalena.ulman@sial.com

Cat. No. Product Name Composition

69222 Glucose Standard for IC C6H12O6 in water
72669 Fructose Standard for IC C6H12O6 in water
72622 Lactose Standard for IC C12H22O11 in water
69631 Sucrose Standard for IC C12H22O11 in water
72637 Galactose Standard for IC C6H12O6 in water
69755 Sorbitol Standard for IC C6H14O6 in water
69714 Mannitol Standard for IC C6H14O6 in water
72619 Glycerol Standard for IC HOCH2CH(OH)CH2OH
in water
72561 Xylitol Standard for IC HOCH2[CH(OH)]3CH2OH
in water

Please visit our website for more information:

sigma-aldrich.com/ic
References:
[1] Brown, S. R.; Schnute, W. C.; Miller, M.; and Wang, J. (L.) Specific and Selective
Ion chromatography is a well-established method for the analysis of Detection for Food and Beverage Analysis by Ion Chromatography-Mass
ionic compounds in the food and beverages consumed by people Spectrometric Detection. Thermo Fisher Scientific 2011.
every day. Sugar is a carbohydrate that occurs naturally in many [2] Bruce, J. The Analysis of Sugars Using Ion Chromatography, Metrohm (UK)
kinds of food such as milk, fruits, vegetables, cereals, and grains. 2002.
Sugar is also an important nutrient that supplies energy to the body. [3] Suksom, W.; Wannachai, W.; Boonchiangma, S.; Chanthai, S.; Srijaranai, S.
Fructose is the sweetest sugar that one can find in nature, occurring Ion Chromatographic Analysis of Monosaccharides and Disaccharides in
in sweet fruits and honey. Lactose can be found in many dairy Raw Sugar, Chromatographia, 2015, 78, 873–879
products such as cheese, butter, yogurt, and milk, which is why it is
important to measure and regulate its quantity. Sugar alcohols are
used in products because they give a sweet taste without the calories
that sugars normally provide. Sorbitol and mannitol are commonly
substituted in place of sucrose. 1–3
Quantitative analysis of certain sugars and sugar alcohols with IC is
of great importance in food analysis because of their prominence
as primary nutrients. A new group of IC TraceCERT carbohydrates
and sugar alcohols is now available. The standards are offered in the
concentration of 1000 mg/L and in HDPE 50 mL bottles.

17
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18 Analytix | 2: 2016

NEW Timestrip® Indicators

The Smart Way to Measure Time and Temperature

Daniel Weibel, Product Manager Analytical Reagents Features & Benefits

daniel.weibel@sial.com
Food and Seafood Timestrips are small (19×30 mm), self-adhesive
In this seventh article about Timestrip smart indicators (1-5: 2015 and labels that can be attached to individual packets or shipments. They
1: 2016), we focus on two of the six new variants recently added to can be stored at room temperature and activated only when needed.
the catalog. Each label has a unique number for traceability, breach indication is
irreversible, and they can be easily and immediately interpreted by
Get Control of Temperature with the the receiver of the shipment.
Timestrip® Food Temp™ Range With Timestrip custom solutions you can even design your own Food
Temp indicator subject to minimum order quantities. Choose your
temperature threshold, time markers and graphics.
For more information on Timestrip, visit our web portal at
sigma-aldrich.com/timestrip or contact timestrip@sial.com

Timestrip Seafood Timestrip Food

Cat. No. Description
3 °C threshold 5 °C threshold NEW 06732 Timestrip Seafood
NEW 07475 Timestrip Food
Food and seafood wholesalers, retailers, and caterers are facing NEW 89148 Timestrip 1 hour
increased regulation of cold chain transport and require monitoring NEW 88790 Timestrip 7 days
solutions for temperature reassurance and audits. The Food Temp NEW 80956 Timestrip 12 hours
range of the Timestrip analog temperature indicator offers the most NEW 80826 Timestrip PLUS 8 °C 48 hours
user-friendly, relevant, and cost-effective monitoring solution 93064 Timestrip 1 month
of its type. 07603 Timestrip 3 months
Two variants, Food and Seafood, can be ordered from the catalog. 03849 Timestrip 3 months, key chain
Once activated, each one monitors temperature and indicates only 06797 Timestrip 6 months
if cumulative breaches of 5 °C (Food) or 3 °C (Seafood) have reached 74831 Timestrip 12 months
a minimum of 2 hours. Monitoring then continues with further
06929 Timestrip 12 months, key chain
breaches recorded up to a maximum of 4 hours (Figure 1).
06693 Timestrip Plus -20 °C
Applications 92210 Timestrip Plus 0 °C
The Food Temp range has widespread applications, including: 08168 Timestrip Plus 8 °C

• Fresh seafood and produce transport 92451

80474
Timestrip Plus 25 °C
Timestrip Plus 30 °C
• Shipment of restaurant food samples to laboratories for testing 80476 Timestrip Plus Duo 10 °C and 34 °C
• Catering: airline and train, school meals, lunch boxes, home
delivery, restaurants
Table 1. Each Timestrip is Available in the Following Package Sizes: 10EA,
100EA, 500EA.

• Premium food retailing, hub and spoke production

Figure 1. Activation of a Timestrip Food Indicator.

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Feature Article
NPC 19

New European Reference Materials (ERMs)

on the Market
The IRMM has Released New CRMs for a Specific Cancer Marker
and Radioactivity in Food
Jens Boertz, Product Manager Analytical Reagents These reference materials will enable GMO testing laboratories
jens.boertz@sial.com to quantify 4114 maize event in food and feed products and to
The Institute for Reference Materials and Measurements (IRMM) implement the labeling threshold for food and feed according to
is one of the seven institutes of the Joint Research Centre (JRC), regulations (EC) No. 1829/2003 and (EC) No. 619/2011.
a Directorate-General of the European Commission (EC). One
objective of IRMM is the support of EU policies with scientific advice Release of New Reference Material for a Specific Cancer Marker
concerning measurements and standards, such as the development JRC scientists have characterized and certified the mass concentration
of reference methods or certified reference materials. The reference of the cancer marker beta-2-microglobulin as an additional parameter
materials of JRC-IRMM cover several areas, such as clinical chemistry, in the certified reference material for proteins in human serum.
the environment, genetically modified organisms (GMOs), industrial This work was done in close collaboration with the International
raw materials, occupational hygiene and physical properties, as well Federation of Clinical Chemistry and Laboratory Medicine (IFCC) for
as food and agriculture. the standardization of measurements of proteins.
The detection and quantification of beta-2-microglobulin is
important for the diagnosis and monitoring of multiple myeloma
and lymphoma. The levels of beta-2-microglobulin and albumin
in serum samples are used to classify patients into prognostic
groups (including medial survival rates). Despite the current use
of this system in routine analysis, discrepancies were highlighted
between results from different laboratories, leading to difficulties for
implementing the prognosis. For the same reason, the EU Directive
on In Vitro Diagnostic Medical Devices (IVD-MD) (Directive 98/79/EC)
demands traceability of calibrants and control materials to common
reference measurement procedures and/or reference materials of
higher order.
Therefore, the reference material ERM®-DA470k/IFCC was produced,
characterized and certified for beta-2-microglobulin in accordance
with ISO Guide 34. An inter-laboratory comparison was performed
with adherence to the quality requirements of ISO/IEC 17025. Details
of the work are described in the additional certification report,
available together with the certificate in our online catalog.
© European Communities, 2015
Read more about the certification of beta-2-microglobulin in
GMO-certified Reference Materials for ERMDA470 in the certification report.
DP-ØØ4114-3 Maize Released
Genetically modified organisms (GMOs) need to be authorized ERMEB074 and ERMEB075 – Testing the Quality of Copper
before they are allowed to enter the European market. The availability Given its physical and chemical properties (ductility, excellent
of a reference material and a validated method, together with the thermal and electrical conductivity, corrosion resistance) and its high
risk assessment, are prerequisites for a possible authorization of antimicrobial activity, copper is used in many sectors and industries:
DP-ØØ4114-3 maize event for the European market. building construction, power generation and transmission, electronic
DuPont Pioneer (U.S.) developed the genetically modified 4114 product manufacturing, production of industrial machinery and the
maize event (unique identifier code DP-ØØ4114-3) as a transgenic transportation sector.
insect-resistant and herbicide-tolerant crop. The event contains The demand for refined copper was estimated at 0.5 million tons in
four transgenes, which confer resistance to certain lepidopteran 1900 and was 20 million tons in 2012. The price of copper reflects
and coleopteran pests, as well as tolerance to the herbicide the function of its impurity levels with premiums being paid for very
phosphinothricin (glufosinate). low impurity levels and penalties for high impurity levels. The copper
Pioneer commissioned the JJRC-IRMM to produce a certified reference market is an important globalized market, which drives the need for
material (CRM) for the quantification of this 4114 maize event. international standardization.
A set of five CRMs: (ERMBF439A, B, C, D and E, certified for their With only 5% of copper production and approximately 20% of
DP-ØØ4114-3 maize mass fractions), has now been released. worldwide use, Europe depends on imports of this crucial commodity.
To support European and world trade and to strengthen competition

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20 Analytix | 2: 2016

in the field, JRC-IRMM has produced a suite of certified reference

materials (CRMs) for testing metal impurities in copper.
Pure copper was spiked with impurities at two different levels
and machined into discs, rods, and chips, with each form being
best suited to specific analytical methods for the determination
of trace elements in copper. Each form was then packaged and
made available for distribution. Extensive homogeneity studies
demonstrated that the trace metal content at each level was
homogeneous across forms and units.
The certified values were assigned based on the results from an
inter-laboratory comparison, involving laboratories of demonstrated
competence. Fifteen laboratories from the EU, USA, and Canada
determined the trace metal content using 12 different analytical
methods. After technical and statistical evaluation and a multi-step peer-
review process, certified values and their uncertainties were assigned:
• For the low-level materials ERMEB074A, B and C, certified values
for 20 elements and indicative values for another 5 elements were
assigned. For the high-level materials ERMEB075A, B and C, certified
values for 24 elements and indicative values for another three
elements were assigned
The whole project was conducted in line with JRC-IRMM’s accreditation © European Communities, 2015
for the production of reference materials. A detailed report is available
via our web catalog.

JRC-IRMM Releases its First Reference Material Certified for

Cat. No. Description Certified Property
Radioactivity in a Food Matrix IRMM426
ERMAD482 Ruminant pDNA calibrant DNA sequence
JRC-IRMM has developed and released the first fruit matrix reference
ERMAD483 Porcine pDNA calibrant DNA sequence
material (IRMM 426 Wild Berries) certified for the two most important
anthropogenic (man-made) radionuclides, 137Cs and 90Sr, and for the ERMEC680M Polyethylene Element content
natural 40K. This reference material supports the precise measurement ERMEC681M Polyethylene Element content
of radionuclides in agricultural products. ERMBF439A DP-004114-3 maize GMO mass fraction
The 2011 accident in the Fukushima Daiichi nuclear power plant ERMBF439B DP-004114-3 maize GMO mass fraction
resulting from the preceding earthquake and tsunami, underlined ERMBF439C DP-004114-3 maize GMO mass fraction
the need for reference materials of radionuclides in food to support ERMBF439D DP-004114-3 maize GMO mass fraction
accurate measurements as a basis for making undisputable decisions ERMBF439E DP-004114-3 maize GMO mass fraction
on radiological protection. Reference materials are needed for many ERMBF438A VCO-01981-5 maize GMO mass fraction
types of food, and dried bilberry material may serve as a representative ERMBF438B VCO-01981-5 maize GMO mass fraction
for vegetables and fruit, in particular, as it is not possible to make ERMBF438C VCO-01981-5 maize GMO mass fraction
reference materials of every possible type of food.
ERMBF438D VCO-01981-5 maize GMO mass fraction
Bilberry samples were collected in a region close to the Chernobyl ERMBF438E VCO-01981-5 maizeE GMO mass fraction
reactor site, but outside the exclusion zone. Due to natural uptake
IRMM426 Wild Berries Isotope amount content
from elevated levels in the environment, the radionuclides 90Sr and
IRMM427 Pike Perch Organic pollutants
137
Cs were metabolized by the plants. The elevated levels of 137Cs
and, in particular, 90Sr are below the exemption levels, allowing free IRMM428 Water Organic pollutants
transport and easy laboratory handling of the material. The material ERMEF001 Biodiesel Element content
was processed at JRC-IRMM by oven-drying, cryo-milling, sieving and ERMEB074A Electrolytic copper Element content
homogenization; it was finally bottled in units of approximately 100 g. ERMEB074B Electrolytic copper Element content
The material was sterilized by gamma-irradiation against degradation. ERMEB074C Electrolytic copper Element content
The certified values of IRMM426 are traceable to the SI units (Bq ERMEB075A Electrolytic copper with Element content
and kg) and were established by nine laboratories from national added impurities
metrology institutes, the IAEA and JRC-IRMM. ERMEB075B Electrolytic copper with Element content
The new reference material IRMM426 was processed, characterized added impurities
and certified in accordance with ISO Guide 34. Details about material ERMEB075C Electrolytic copper with Element content
sampling, processing, characterization and certification are described added impurities
in the certification report, available together with the certificate online.

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Feature Article
NPC 21

NIST Standard Reference Materials® of Ferrous Metals

More than 100 new SRMs for steel, alloy, and cast iron analysis are available now

Jens Boertz, Product Manager Analytical Reagents

jens.boertz@sial.com
The National Institute for Standards and Technology (NIST) is
one of the oldest physical science laboratories in the U.S. The U.S.
Congress established the agency to remove a major handicap to U.S.
industrial competitiveness at the time – a second-rate measurement
infrastructure that lagged behind the capabilities of England, Germany,
and other economic rivals. Today, NIST measurements support the
smallest of technologies – nanoscale devices so tiny that tens of
thousands can fit on the end of a single human hair – to the largest
and most complex of human creations, from earthquake-resistant
skyscrapers to wide-body jetliners to global communication networks.
We are proud to be the first licensed distributor of NIST Standard
Reference Materials. The following tables provide an overview of
ferrous SRMs certified for element content currently available.
Low Alloy Steels (chip form)
The up-to-date list of all SRMs can be found at Cat. No. SRM Code Description Pkg Size
sigma-aldrich.com/nist
NIST30F SRM 30F Cr-V Steel (SAE 6150) 150 G
Plain Carbon Steels (chip form) NIST32E SRM 32E LA Steel, Ni-Cr (SAE 3140) 150 G
Cat. No. SRM Code Description Pkg Size NIST33E SRM 33E Nickel Steel 150 G
NIST8K SRM 8K Bessemer steel (simulated) 150 G NIST36B SRM 36B LA Steel, Cr-Mo 150 G
0.1% carbon NIST72G SRM 72G Low Alloy Steel (AISI 4130) 150 G
NIST12H SRM 12H Basic Open-Hearth Steel 150 G NIST100B SRM 100B Manganese Steel 150 G
0.4% Carbon NIST106B SRM 106B LA Steel, Cr-Mo-Al (Nitralloy rG) 150 G
NIST13G SRM 13G Carbon Steel, 0.6% 150 G NIST125B SRM 125B LA Steel High Silicon 100 G
NIST14G SRM 14G Carbon Steel, (AISI 1078) 150 G NIST129C SRM 129C LA Steel, High Sulfur (SAE 112) 150 G
NIST16F SRM 16F Basic Open-Hearth Steel 150 G NIST139B SRM 139B Chromium-Nickel-Molybdenum 150 G
1% Carbon Steel
NIST19H SRM 19H Basic Electric Steel 0.2% Carbon 150 G NIST155 SRM 155 Chromium-Tungsten Steel 150 G
NIST20G SRM 20G AISI 1045 steel 150 G NIST163 SRM 163 Chromium Steel 100 G
NIST152A SRM 152A Basic Open-Hearth Steel 150 G NIST179 SRM 179 LA Steel, High Silicon 150 G
0.5% Carbon (Tin Bearing) NIST291 SRM 291 Cr-Mo Steel (ASTM A-213) 150 G
NIST178 SRM 178 0.4C Basic Oxygen Furnace Steel 150 G NIST293 SRM 293 Cr-Ni-Mo (AISI 8620) 150 G
NIST368 SRM 368 Steel (AISI 1211) 150 G NIST2171 SRM 2171 LA Steel (HSLA 100) 150 G

Special Low Alloy Steels (chip and pin forms)

Cat. No. SRM Code Description Pkg Size
NIST361 SRM 361 LA Steel (AISI 4340) 150 G
NIST363 SRM 363 LA Steel, Cr-V (mod.) 150 G
NIST364 SRM 364 LA Steel, High C (mod.) 150 G
NIST2159 SRM 2159 LA Steel, Carbon & Sulfur Only 150 G
NIST2160 SRM 2160 LA Steel, Carbon & Sulfur only 150 G
NIST2165 SRM 2165 Low Alloy Steel 150 G
NIST2166 SRM 2166 LA Steel, F 150 G
NIST2167 SRM 2167 Low Alloy Steel 150 G
NIST2168 SRM 2168 High Purity Iron 150 G

21
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22 Analytix | 2: 2016

Low Alloy Steels (disk and rod forms)

Cat. No. SRM Code Description Pkg Size
NIST663 SRM 663 Chromium-Vanadium Steel 5 RODS
(Modified)
NIST665 SRM 665 Electrolytic Iron 5 RODS
NIST1134 SRM 1134 LA Steel, High Silicon DISK
NIST1135 SRM 1135 LA Steel, High Silicon DISK
NIST1218 SRM 1218 LA Steel, High Silicon DISK
NIST1224 SRM 1224 LA Steel, Carbon (AISI 1078) DISK
NIST1225 SRM 1225 LA Steel AISI 4130 DISK
NIST1226 SRM 1226 LA Steel DISK
NIST1227 SRM 1227 LA Steel, Basic Open Hearth, 1% C DISK
NIST1228 SRM 1228 LA Steel 0.1% C DISK
High Alloy Steels (chip form) NIST1264A SRM 1264A LA Steel, High Carbon (mod.) DISK
Cat. No. SRM Code Description Pkg Size NIST1265A SRM 1265A Electrolytic Iron DISK
NIST126C SRM 126C High Alloy Steel, High Nickel 150 G NIST1269 SRM 1269 Line Pipe (AISI 1526 mod) DISK
NIST344 SRM 344 15 Chromium-7 Nickel Steel 150 G NIST1270 SRM 1270 LA Steel, Cr-Mo (A336) (F-22) DISK
(Mo Precipitation Hardening) NIST1271 SRM 1271 LA Steel (HSLA-100) DISK
NIST346A SRM 346A Valve Steel 150 G NIST1286 SRM 1286 Low Alloy Steel (HY 80) DISK
NIST862 SRM 862 High-Temperature Alloy L 605 150 G NIST1761A SRM 1761A Low Alloy Steel DISK
NIST868 SRM 868 High Temp Alloy Fe-Ni-Co 150 G NIST1762A SRM 1762A Low Alloy Steel DISK
NIST1763A SRM 1763A Low Alloy Steel DISK
Gases in Ferrous Metals (rod and disk form)
NIST1764A SRM 1764A Low Alloy Steel DISK
Cat. No. SRM Code Description Pkg Size
NIST1765 SRM 1765 Low Alloy Steel DISK
NIST1089 SRM 1089 Steels, Set (consists of SRMs 1095, SET
1096, 1097, 1098 and 1099) NIST1766 SRM 1766 Low Alloy Steel DISK
NIST1090 SRM 1090 Oxygen in Ingrot Iron ROD NIST1767 SRM 1767 Low Alloy Steel DISK
NIST1091A SRM 1091A Oxygen in Stainless Steel (AISI 431) ROD NIST1768 SRM 1768 High-Purity Iron DISK
NIST1093 SRM 1093 Oxygen in Valve Steel ROD High-Temperature Alloys (chip and disk forms)
NIST1094 SRM 1094 Oxygen in Maraging Steel ROD Cat. No. SRM Code Description Pkg Size
NIST1754 SRM 1754 Low-Alloy Steel, AISI 4320 ROD NIST866 SRM 866 Incoloy 800 100 G
NIST1755 SRM 1755 Nitrogen in Low Alloy Steel DISK NIST867 SRM 867 Incoloy, 825 100 G
Stainless Steels (chip form) NIST1230 SRM 1230 High-Temperature Alloy A286 DISK
Cat. No. SRM Code Description Pkg Size NIST1246 SRM 1246 Incoloy 800 DISK
NIST73C SRM 73C Stainless Steel, Cr (SAE 420) 150 G NIST1247 SRM 1247 Incoloy 825 DISK
NIST101G SRM 101G Stainless Steel (AISI 304L) 100 G NIST1250 SRM 1250 High Temp. Alloy Fe-Ni-Co DISK
NIST123C SRM 123C Stainless Steel Cr-Ni-Nb (AISI 348) 150 G NISTC2400 SRM C2400 High-Alloy Steel ACI (17/4 PH) DISK
NIST160B SRM 160B Stainless Steel Cr-Ni-Mo (AISI 316) 150 G NISTC2401 SRM C2401 HA Steel (ACI-C-4M-Cu) DISK
NIST166C SRM 166C Stainless Steel, Low-Carbon 100 G
(AISI 316L)
NIST339 SRM 339 17 Chromium-9 nickel-0.2 150 G
selenium steel
NIST343A SRM 343A Stainless Steel (AISI 431) 150 G
NIST893 SRM 893 Stainless Steel (SAE 405) 150 G
NIST895 SRM 895 Stainless Steel (SAE 201) 150 G

Tool Steels (chip form)

Cat. No. SRM Code Description Pkg Size
NIST50C SRM 50C Tungsten-Chromium- 150 G
Vanadium Steel
NIST132B SRM 132B Tool steel (AISI M2) 150 G
NIST134A SRM 134A Molybdenum-Tungsten- 150 G
Chromium-Vanadium Steel
NIST2172 SRM 2172 S-7 Tool Steel 150 G

sigma-aldrich.com/analytix
sigma-aldrich.com/nist 22
 Back to Table of Contents

Feature Article
NPC 23

Steelmaking Alloys (powder form)

Cat. No. SRM Code Description Pkg Size
NIST57B SRM 57B Silicon Metal 40 G
NIST58A SRM 58A Ferrosilicon (73% Si) 75 G
NIST59A SRM 59A Ferrosilicon 50 G
NIST64C SRM 64C Ferrochromium, High Carbon 100 G
NIST68C SRM 68C Ferromanganese, High Carbon 100 G
NIST90 SRM 90 Ferrophosphorus 75 G
NIST195 SRM 195 Ferrosilicon (75% Si-HP Grade) 75 G
NIST196 SRM 196 Ferrochromium, (Low-Carbon) 100 G
NIST689 SRM 689 Ferrochromium Silicon 100 G

Cast Irons (chip form)

Cat. No. SRM Code Description Pkg Size
Stainless Steels (disk form)
NIST4L SRM 4L Cast Iron 150 G
Cat. No. SRM Code Description Pkg Size
NIST6G SRM 6G Cast Iron 150 G
NIST1155A SRM 1155A Stainless Steel (Cr 18 Ni 12 Mo 2) DISK
NIST82B SRM 82B Nickel-Chromium Cast Iron 150 G
NIST1171 SRM 1171 Stainless Steel Cr17-Ni11-Ti0.3 DISK
NIST107C SRM 107C Cast Iron (Ni-Cr-Mo) 150 G
AISI 321
NIST115A SRM 115A Copper-Nickel-Chromium Cast Iron 150 G
NIST1172 SRM 1172 Stainless Steel Cr 17-Ni 11-Nb 0.6 DISK
(AISI 348) NIST122I SRM 122I Cast Iron 150 G
NIST1219 SRM 1219 Cr16-Ni2 (AISI 431) DISK NIST334 SRM 334 Gray Cast Iron 150 G
NIST 1223 SRM 1223 Chromium Steel DISK NIST338 SRM 338 White Cast Iron (Carbon & Sulfur) 150 G
NIST 1295 SRM 1295 Stainless Steel (SAE 405) DISK NIST341 SRM 341 Ductile Cast Iron 150 G
NIST1297 SRM 1297 Stainless Steel (SAE 201) DISK NIST342A SRM 342A Nodular Cast Iron 150 G
NIST C1151A SRM C1151A Stainless Steel 23Cr-7Ni DISK NIST892 SRM 892 High-Alloy White Cast Iron (Ni- 150 G
Hard, Type IV)
NIST C1152A SRM C1152A Stainless Steel 18Cr-11Ni DISK
NIST C1153A SRM C1153A Stainless Steel 17Cr-9Ni DISK Cast Steels, White Cast Irons, and Ductile Irons (disk form)
NIST C1154A SRM C1154A Stainless Steel 19Cr-13Ni DISK Cat. No. SRM Code Description Pkg Size
NIST C1296 SRM C1296 Stainless Steel DISK NIST1138A SRM 4L Cast Iron 150 G
NIST1139A SRM 6G Cast Iron 150 G
Speciality Steels (disk form)
NIST1173 SRM 82B Nickel-Chromium Cast Iron 150 G
Cat. No. SRM Code Description Pkg Size
NISTC 1137A SRM 107C Cast Iron (Ni-Cr-Mo) 150 G
NIST1157 SRM 1157 Tool Steel (AISI M2) DISK
NISTC 1145A SRM 115A Copper-Nickel-Chromium Cast Iron 150 G
NIST1158 SRM 1158 High-Nickel Steel (36% Ni) DISK
NISTC1173 SRM 122I Cast Iron 150 G
NIST1772 SRM 1772 Tool Steel (S-7) DISK
NISTC1290 SRM 334 Gray Cast Iron 150 G
NISTC1291 SRM 338 White Cast Iron (Carbon & Sulfur) 150 G
NISTC1292 SRM 341 Ductile Cast Iron 150 G
NISTC2424 SRM 342A Nodular Cast Iron 150 G

23
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