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(EST)
Printed by: Le Tran Official Date: Omitted on 01-Dec-2020 Document Type: USP @2021 USPC
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Delete the following: rU = peak response of sulfacetamide from the Sample

solution
rS = peak response of sulfacetamide from the Standard
▲
Sulfacetamide solution
CS = concentration of USP Sulfacetamide RS in the
Standard solution (mg/mL)

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

Acceptance criteria: 99.0%–100.5% on the dried basis

IMPURITIES

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• RESIDUE ON IGNITION á281ñ: NMT 0.1%
• CHLORIDE AND SULFATE á221ñ, Sulfate
C8H10N2O3S 214.24 Sample: 1 g
Acetamide, N-[(4-aminophenyl)sulfonyl]-; Analysis: Digest the Sample with 50 mL of water at about
N-Sulfanilylacetamide [144-80-9]. 70° for 5 min. Cool immediately to room temperature, and

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filter.
DEFINITION
Acceptance criteria: 0.04%; a 25-mL portion of the filtrate
Sulfacetamide contains NLT 99.0% and NMT 100.5% of
shows no more sulfate than corresponds to 0.2 mL of
sulfacetamide (C8H10N2O3S), calculated on the dried basis.
0.02 N sulfuric acid.
IDENTIFICATION • SELENIUM á291ñ
• A. INFRARED ABSORPTION á197Kñ Sample: 200 mg

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• B. The retention time of the major peak of the Sample Acceptance criteria: 30 ppm
solution corresponds to that of the Standard solution, as • ORGANIC IMPURITIES
obtained in the Assay. Mobile phase: Methanol, water, and glacial acetic acid
(10:89:1)
ASSAY Diluent: Methanol and Solution A (10:90)
• PROCEDURE System suitability solution: 0.2 mg/mL of USP
Solution A: 1% glacial acetic acid
er Sulfacetamide RS and 0.05 mg/mL of USP Sulfanilamide RS
Solution B: Methanol in Diluent. Sonicate for 5 min to dissolve.
Diluent: Methanol and Solution A (10:90) Standard solution: 2 µg/mL of USP Sulfacetamide RS and
Mobile phase See Table 1. 4 µg/mL of USP Sulfanilamide RS in water
Sample solution: 2 mg/mL of Sulfacetamide in water
Table 1 Chromatographic system
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Time Solution A Solution B (See Chromatography á621ñ, System Suitability.)

(min) (%) (%) Mode: LC
0 90 10 Detector: UV 254 nm
Column: 4.6-mm × 15-cm; 5-µm packing L1
5 90 10 Flow rate: 0.8 mL/min
9.5 10 90 Injection volume: 10 µL
System suitability
9.6 90 10 Samples: System suitability solution and Standard solution
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14 90 10 Suitability requirements
Resolution: NLT 5.0 between sulfacetamide and
sulfanilamide, System suitability solution
Standard solution: 0.2 mg/mL of USP Sulfacetamide RS in
Tailing factor: NMT 1.5 for sulfacetamide, Standard
Diluent. Sonicate for 5 min to dissolve.
solution
Sample solution: 0.2 mg/mL of Sulfacetamide in Diluent.
Relative standard deviation: NMT 2.0% for
Sonicate for 5 min to dissolve.
sulfacetamide, Standard solution
Chromatographic system
Analysis
(See Chromatography á621ñ, System Suitability.)
Samples: Standard solution and Sample solution
Mode: LC
Calculate the percentage of sulfanilamide in the portion of
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Detector: UV 254 nm
Sulfacetamide taken:
Column: 4-mm × 12.5-cm; 5-µm packing L1
Flow rate: 0.8 mL/min Result = (rU/rS) × (CS/CU) × 100
Injection volume: 10 µL
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System suitability rU = peak response of sulfanilamide from the Sample

Sample: Standard solution solution
Suitability requirements rS = peak response of sulfanilamide from the Standard
Tailing factor: 0.9–1.8, Standard solution solution
Relative standard deviation: NMT 0.5%, Standard CS = concentration of USP Sulfanilamide RS in the
solution Standard solution (mg/mL)
Analysis CU = concentration of Sulfacetamide in the Sample
Samples: Standard solution and Sample solution solution (mg/mL)
Calculate the percentage of sulfacetamide (C8H10N2O3S) in
the portion of Sulfacetamide taken: Calculate the percentage of any unspecified impurity in the
portion of Sulfacetamide taken:
Result = (rU/rS) × (CS/CU) × 100
Result = (rU/rS) × (CS/CU) × 100

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Printed on: Sun Aug 01 2021, 06:37:41 PM Official Status: No Longer Official on 01-Aug-2021 DocId: 1_GUID-03A09C75-57CB-40D7-83AD-4CD3EC8FA0E0_5_en-US
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Printed by: Le Tran Official Date: Omitted on 01-Dec-2020 Document Type: USP @2021 USPC
2

rU = peak response of any unspecified impurity from SPECIFIC TESTS

the Sample solution • LOSS ON DRYING á731ñ
rS = peak response of sulfacetamide from the Standard Analysis: Dry a sample at 105° for 2 h.
solution Acceptance criteria: NMT 0.5%
CS = concentration of USP Sulfacetamide RS in the • REACTION
Standard solution (mg/mL) Sample solution: 6.67 mg/mL

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CU = concentration of Sulfacetamide in the Sample Acceptance criteria: Acid to litmus
solution (mg/mL) • CLARITY AND COLOR OF SOLUTION
Sample: 200 mg
Acceptance criteria: See Table 2. Analysis: Dissolve the Sample in 5 mL of 1 N sodium
hydroxide.

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Table 2 Acceptance criteria: A yellow to faintly yellow solution
Relative Acceptance having NMT a trace of turbidity is produced.
Retention Criteria,
Name Time NMT (%) ADDITIONAL REQUIREMENTS
• PACKAGING AND STORAGE: Preserve in well-closed,
Sulfanilamide 0.6 0.2 light-resistant containers.

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Sulfacetamide 1.0 — • USP REFERENCE STANDARDS á11ñ
USP Sulfacetamide RS
Any single unspecified impurity — 0.10
USP Sulfanilamide RS
Total impurities — 0.5 p-Aminobenzenesulfonamide.
C6H8N2O2S 172.20▲ (USP 1-Dec-2020)

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