Printed on: Mon Aug 14 2023, 12:26:12 AM(EST) Status: Currently Official on 14-Aug-2023 DocId: GUID-2B1F6B00-AAF1-46C3-A99C-ACEC132879AA_2_en-US

Printed by: Kimberly Suret Official Date: Official as of 01-May-2020 Document Type: USP @2023 USPC
Do Not Distribute DOI Ref: 1x0te DOI: https://doi.org/10.31003/USPNF_M6290_02_01
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PERFORMANCE TESTS
Aspirin Tablets • DISSOLUTION á711ñ
DEFINITION Medium: 0.05 M acetate buffer, prepared by mixing 2.99 g
Aspirin Tablets contain NLT 90.0% and NMT 110.0% of the of sodium acetate trihydrate and 1.66 mL of glacial acetic
labeled amount of aspirin (C9H8O4). Tablets of larger than acid with water to obtain a total of 1000 mL of solution
with a pH of 4.50 ± 0.05; 500 mL
81-mg size contain no sweeteners or other flavors.
Apparatus 1: 50 rpm
[NOTE—Tablets that are enteric-coated meet the
Time: 30 min
requirements for Aspirin Delayed-Release Tablets.]
Standard solution: A known concentration of USP
IDENTIFICATION Aspirin RS in Medium. Prepare the Standard solution at the
• A. The retention time of the aspirin peak of the Sample time of use. [NOTE—A quantity of alcohol not to exceed 1%
solution corresponds to that of the Standard solution, as of the total volume of the Standard solution may be used to
obtained in the Assay. dissolve the Reference Standard prior to dilution with
Medium.]
Change to read: Sample solution: Pass a portion of the solution under test
through a suitable filter, and dilute with Medium, if
• B. ▲SPECTROSCOPIC IDENTIFICATION TESTS á197ñ, Infrared necessary.
Spectroscopy: 197K▲ (CN 1-May-2020) Instrumental conditions
Sample: Shake a quantity of finely powdered Tablets, Mode: UV
equivalent to about 500 mg of aspirin, with 10 mL of Analytical wavelength: 265 nm
alcohol for several min. Centrifuge the mixture. Pour off the Analysis
clear supernatant, and evaporate it to dryness. Dry the Samples: Standard solution and Sample solution

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residue under vacuum at 60° for 1 h. Determine the percentage of the labeled amount of aspirin
Acceptance criteria: Meet the requirements (C9H8O4) dissolved from UV absorbances at the isosbestic
point of aspirin and salicylic acid at about 265 nm.
ASSAY
Tolerances: NLT 80% (Q) of the labeled amount of aspirin
• PROCEDURE
(C9H8O4) is dissolved.
Mobile phase: 2 g/L of sodium 1-heptanesulfonate in a
• UNIFORMITY OF DOSAGE UNITS á905ñ: Meet the
mixture of acetonitrile and water (15:85). Adjust with
glacial acetic acid to a pH of 3.4.
Diluent: Acetonitrile and formic acid (99:1)
Standard solution: 0.5 mg/mL of USP Aspirin RS in Diluent
ci requirements
IMPURITIES
• LIMIT OF FREE SALICYLIC ACID
Sample stock solution: Nominally 5 mg/mL of aspirin Mobile phase, Diluent, and Chromatographic system:
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prepared as follows. Transfer a quantity, equivalent to Proceed as directed in the Assay.
about 100 mg of aspirin from NLT 20 finely powdered System suitability solution: 0.015 mg/mL of USP Salicylic
Tablets, to a suitable container. Add 20.0 mL of Diluent and Acid RS and 0.5 mg/mL of USP Aspirin RS in Diluent
10 glass beads. Shake vigorously for about 10 min, and Standard solution: 0.015 mg/mL of USP Salicylic Acid RS in
centrifuge. Diluent
Sample solution: Nominally 0.5 mg/mL of aspirin in Diluent Sample solution: Use the Sample stock solution prepared as
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from Sample stock solution directed in the Assay.

Chromatographic system System suitability
(See Chromatography á621ñ, System Suitability.) Samples: System suitability solution and Standard solution
Mode: LC [NOTE—The relative retention times for salicylic acid
Detector: UV 280 nm and aspirin are about 0.7 and 1.0, respectively.]
Column: 4.0-mm × 30-cm; packing L1 Suitability requirements
Flow rate: 2 mL/min Resolution: NLT 2.0 between salicylic acid and aspirin,
Injection volume: 10 µL System suitability solution
System suitability Relative standard deviation: NMT 4.0%, Standard
Sample: Standard solution solution
Suitability requirements Analysis
Tailing factor: NMT 2.0 Samples: Standard solution and Sample solution
Relative standard deviation: NMT 2.0% Calculate the percentage of salicylic acid (C7H6O3) in the
Analysis portion of Tablets taken:
Samples: Standard solution and Sample solution
Calculate the percentage of the labeled amount of aspirin Result = (rU/rS) × (CS/CU) × 100
(C9H8O4) in the portion of Tablets taken:
rU = peak response of salicylic acid from the Sample
Result = (rU/rS) × (CS/CU) × 100 solution
rS = peak response of salicylic acid from the Standard
rU = peak response of aspirin from the Sample solution solution
rS = peak response of aspirin from the Standard CS = concentration of USP Salicylic Acid RS in the
solution Standard solution (mg/mL)
CS = concentration of USP Aspirin RS in the Standard CU = nominal concentration of aspirin in the Sample
solution (mg/mL) solution (mg/mL)
CU = nominal concentration of aspirin in the Sample
solution (mg/mL) Acceptance criteria: NMT 0.3%; for coated Tablets: NMT
3.0%
Acceptance criteria: 90.0%–110.0%

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Printed on: Mon Aug 14 2023, 12:26:12 AM(EST) Status: Currently Official on 14-Aug-2023 DocId: GUID-2B1F6B00-AAF1-46C3-A99C-ACEC132879AA_2_en-US
Printed by: Kimberly Suret Official Date: Official as of 01-May-2020 Document Type: USP @2023 USPC
Do Not Distribute DOI Ref: 1x0te DOI: https://doi.org/10.31003/USPNF_M6290_02_01
2

ADDITIONAL REQUIREMENTS • USP REFERENCE STANDARDS á11ñ

• PACKAGING AND STORAGE: Preserve in tight containers. USP Aspirin RS
Preserve flavored or sweetened Tablets of 81-mg size or USP Salicylic Acid RS
smaller in containers holding NMT 36 Tablets each.

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