USP-NF Acetone

11/6/2020 USP-NF Acetone
Printed on: Fri Nov 06 2020, 15:29:57 pm

Printed by: Shruti Kharidia
O cial Status: Currently O cial on 06-Nov-2020
O cial Date: O cial as of 1-May-2020
Document Type: NF
DocId: 1_GUID-6DBB0D9B-0E6A-41FE-91A1-9F6D73BE2568_4_en-US
Printed from: https://online.uspnf.com/uspnf/document/1_GUID-6DBB0D9B-0E6A-41FE-91A1-9F6D73BE2568_4_en-US
© 2020 USPC
Acetone
C3H6O 58.08
2-Propanone;
Acetone [67-64-1].
DEFINITION
Acetone contains NLT 99.0% of C3H6O, calculated on the anhydrous basis.
[CAUTION—Acetone is very ammable. Do not use where it may be ignited.]
IDENTIFICATION
Change to read:
• A. ▲SPECTROSCOPIC IDENTIFICATION TESTS 〈197〉, Infrared Spectroscopy: 197F▲ (CN 1-MAY-2020)
• B. The retention time of the Sample corresponds to that of USP Acetone RS, as obtained in the Assay.
ASSAY
• PROCEDURE
Sample: Acetone
L
System suitability solution: Dilute 1.0 mL of USP Methyl Alcohol RS and 1.0 mL of USP Acetone RS with tetrahydrofuran to 50 mL.
IA
Chromatographic system
(See Chromatography 〈621〉, System Suitability.)
Mode: GC
Detector: Flame ionization
Column: 0.32-mm × 30-m fused-silica capillary; 1.8-µm of phase G43
IC
Temperature
Column: See Table 1.
Table 1
FF
Hold Time at Final

Initial Temperature (°) Temperature Ramp (°/min) Final Temperature (°) Temperature (min)
40 0 40 5
O
40 20 240 —
Injector: 200°
Detector: 280°
Carrier gas: Helium
Flow rate: 35 cm/s (linear velocity)
Split ratio: 400:1
Injection volume: 1 µL
System suitability
Sample: System suitability solution
[NOTE—The relative retention times for methyl alcohol, acetone, and tetrahydrofuran are about 0.6, 1.0, and 1.9, respectively.]
Suitability requirements
Resolution: NLT 15 between the methyl alcohol and acetone peaks
Analysis
Sample: Sample
Calculate the percentage of acetone (C3H6O) in the portion of Acetone taken:
Result = (rU/rT) × 100
https://online.uspnf.com/uspnf/document/1_GUID-6DBB0D9B-0E6A-41FE-91A1-9F6D73BE2568_4_en-US?source=TOC 1/3
rU = peak area due to the acetone peak in the Sample
rT = sum of the areas of all the peaks in the Sample
[NOTE—No separate correction is applied for water content, because water does not respond to the ame-ionization detector.]
Acceptance criteria: NLT 99.0% on the anhydrous basis
SPECIFIC TESTS
• SPECIFIC GRAVITY 〈841〉: NMT 0.789
• NONVOLATILE RESIDUE: Evaporate 50 mL in a tared porcelain dish on a steam bath, and dry at 105° for 1 h.
Acceptance criteria: The weight of the residue does not exceed 2 mg (0.004%).
• WATER
Sample: Acetone
Standard solution: Transfer 0.50 mL of water to a dry 100-mL volumetric ask, dilute with dehydrated isopropyl alcohol to volume, and
mix.
Blank: Dehydrated isopropyl alcohol
Chromatographic system
(See Chromatography 〈621〉, System Suitability.)
Mode: GC
Detector: Thermal conductivity
Column: 0.32-mm × 50-m capillary; 5.0-µm layer of support S2
Temperature
Column: See Table 2.
Table 2
Hold Time at Final

Initial Temperature (°)
100
Temperature Ramp (°/min)
25
L Final Temperature (°)
190
Temperature (min)
—
IA
Injector: 250°
Detector: 250°
IC
Carrier gas: Helium

Flow rate: 11 mL/min
Split ratio: 4.5:1
Injection size: 1.0 µL
Analysis
FF
Samples: Acetone, Standard solution, and Blank

[NOTE—Identify the peaks based on their relative retention times, which are 1.0 for water and about 1.9 for isopropyl alcohol.]
Acceptance criteria: The area of the water peak for Acetone is NMT that from the Standard solution, corrected for the area of the
water peak from the Blank (0.5%).
• READILY OXIDIZABLE SUBSTANCES
O
Analysis: Mix 20 mL with 0.10 mL of 0.10 N potassium permanganate in a glass-stoppered bottle.

Acceptance criteria: The permanganate color of the mixture does not completely disappear within 15 min.
ADDITIONAL REQUIREMENTS
• PACKAGING AND STORAGE: Preserve in tight containers, remote from re.
• USP REFERENCE STANDARDS 〈11〉
USP Acetone RS
USP Methyl Alcohol RS
Auxiliary Information- Please check for your question in the FAQs before contacting USP.
Topic/Question Contact Expert Committee
ACETONE Galina Holloway SE2020 Simple Excipients

Senior Scienti c Liaison
Chromatographic Database Information: Chromatographic Database
Most Recently Appeared In:

Pharmacopeial Forum: Volume No. 34(1)
Page Information:
USP43-NF38 - 5600
USP42-NF37 - 5554
USP41-NF36 - 5182
Current DocID: GUID-6DBB0D9B-0E6A-41FE-91A1-9F6D73BE2568_4_en-US
L
IA
IC
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11/6/2020 USP-NF Acetone

Printed on: Fri Nov 06 2020, 15:29:57 pm

Hold Time at Final

Result = (rU/rT) × 100

rT = sum of the areas of all the peaks in the Sample

Hold Time at Final

Carrier gas: Helium

Samples: Acetone, Standard solution, and Blank

Analysis: Mix 20 mL with 0.10 mL of 0.10 N potassium permanganate in a glass-stoppered bottle.

Topic/Question Contact Expert Committee

ACETONE Galina Holloway SE2020 Simple Excipients

Chromatographic Database Information: Chromatographic Database

Most Recently Appeared In:

Current DocID: GUID-6DBB0D9B-0E6A-41FE-91A1-9F6D73BE2568_4_en-US

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