USP-NF Acetylcysteine

11/6/2020 USP-NF Acetylcysteine
Printed on: Fri Nov 06 2020, 15:30:19 pm

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O cial Status: Currently O cial on 06-Nov-2020
O cial Date: O cial as of 1-May-2020
Document Type: USP & NF
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© 2020 USPC
Acetylcysteine
C5H9NO3S 163.19
L-Cysteine, N-acetyl-;
N-Acetyl-L-cysteine [616-91-1].
DEFINITION
Acetylcysteine contains NLT 98.0% and NMT 102.0% of C5H9NO3S, calculated on the dried basis.
IDENTIFICATION
Change to read:
• A. ▲SPECTROSCOPIC IDENTIFICATION TESTS 〈197〉, Infrared Spectroscopy: 197K▲ (CN 1-MAY-2020)
ASSAY
• PROCEDURE
L
Mobile phase: 6.8 g/L of monobasic potassium phosphate. Adjust with phosphoric acid to a pH of 3.0.
Sodium metabisul te solution: 0.5 mg/mL of sodium metabisul te in water, freshly prepared
Internal standard solution: 5 mg/mL of USP L-Phenylalanine RS in Sodium metabisul te solution
IA
Standard stock solution: 10 mg/mL of USP Acetylcysteine RS in Sodium metabisul te solution
Standard solution: 0.5 mg/mL of USP Acetylcysteine RS and 0.25 mg/mL of USP L-Phenylalanine RS in Sodium metabisul te solution
from Standard stock solution and Internal standard solution
Sample stock solution: 10 mg/mL of Acetylcysteine in Sodium metabisul te solution
IC
Sample solution: 0.5 mg/mL of Acetylcysteine and 0.25 mg/mL of USP L-Phenylalanine RS in Sodium metabisul te solution from
Sample stock solution and Internal standard solution
Chromatographic system
(See Chromatography 〈621〉, System Suitability.)
Mode: LC
FF
Detector: UV 214 nm
Column: 3.9-mm × 30-cm; packing L1
Flow rate: 1.5 mL/min
Injection size: 5 µL
System suitability
O
Sample: Standard solution

[NOTE—The relative retention times for acetylcysteine and L-phenylalanine are about 0.5 and 1.0, respectively.]
Suitability requirements
Resolution: NLT 6 between acetylcysteine and L-phenylalanine
Relative standard deviation: NMT 2.0%
Analysis
Samples: Standard solution and Sample solution
Calculate the percentage of acetylcysteine (C5H9NO3S) in the portion of Acetylcysteine taken:
Result = (RU/RS) × (CS/CU) × 100
RU = peak response ratio of acetylcysteine to L-phenylalanine from the Sample solution
RS = peak response ratio of acetylcysteine to L-phenylalanine from the Standard solution
CS = concentration of USP Acetylcysteine RS in the Standard solution (mg/mL)
CU = concentration of acetylcysteine in the Sample solution (mg/mL)
Acceptance criteria: 98.0%–102.0% on the dried basis
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11/6/2020 USP-NF Acetylcysteine
IMPURITIES
• RESIDUE ON IGNITION 〈281〉: NMT 0.5%
SPECIFIC TESTS
• OPTICAL ROTATION, Specific Rotation〈781S〉
Buffer: Mix 29.5 mL of 1 N sodium hydroxide, 50 mL of 1 M monobasic potassium phosphate, and su cient water to make 100 mL.
Adjust to a pH of 7.0 ± 0.1 by adding more of either solution, as necessary.
Sample solution: In a 25-mL volumetric ask, mix 1.25 g with 1 mL of edetate disodium solution (1 in 100), add 7.5 mL of sodium
hydroxide solution (1 in 25), and mix to dissolve. Dilute with Buffer to volume.
Acceptance criteria: +21° to +27°
• PH 〈791〉: 2.0–2.8 in a solution (1 in 100)
• LOSS ON DRYING 〈731〉: Dry a sample at a pressure of about 50 mm of mercury at 70° for 4 h: it loses NMT 1.0% of its weight.
ADDITIONAL REQUIREMENTS
• PACKAGING AND STORAGE: Preserve in tight containers, and store at controlled room temperature.
• USP REFERENCE STANDARDS 〈11〉
USP Acetylcysteine RS
USP L-Phenylalanine RS
Auxiliary Information- Please check for your question in the FAQs before contacting USP.
Topic/Question Contact Expert Committee
ACETYLCYSTEINE Hillary Z Cai SM22020 Small Molecules 2

Senior Scienti c Liaison
Chromatographic Database Information: Chromatographic Database
L
IA
Most Recently Appeared In:
Pharmacopeial Forum: Volume No. 31(3)
Page Information:
USP43-NF38 - 82
IC
USP42-NF37 - 83
USP41-NF36 - 74
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11/6/2020 USP-NF Acetylcysteine

Printed on: Fri Nov 06 2020, 15:30:19 pm

Sample: Standard solution

Result = (RU/RS) × (CS/CU) × 100

RU = peak response ratio of acetylcysteine to L-phenylalanine from the Sample solution

RS = peak response ratio of acetylcysteine to L-phenylalanine from the Standard solution

CS = concentration of USP Acetylcysteine RS in the Standard solution (mg/mL)

CU = concentration of acetylcysteine in the Sample solution (mg/mL)

Acceptance criteria: 98.0%–102.0% on the dried basis

Topic/Question Contact Expert Committee

ACETYLCYSTEINE Hillary Z Cai SM22020 Small Molecules 2

Chromatographic Database Information: Chromatographic Database

Current DocID: GUID-0A0860CC-95B7-4A42-BDF5-19DFDEBBC098_4_en-US

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