Aspirin Effervescent Tablets for Oral Solution

This article is compiled based on the United States Pharmacopeia (USP) – 2025 Edition

Issued and maintained by the United States Pharmacopeial Convention (USP)

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1 DEFINITION

Aspirin Effervescent Tablets for Oral Solution contain Aspirin and an effervescent mixture of a suitable organic acid and an alkali metal bicarbonate and/or carbonate. Tablets contain NLT 90.0% and NMT 110.0% of the labeled amount of aspirin (C₉H₈O₄)

2 IDENTIFICATION

A. The retention time of the aspirin peak of the Sample solution corresponds to that of the Standard solution, as obtained in the Assay.

B.

Sample: ½ Tablet

Analysis: Add the Sample to 50 mL of water in a flask, and immediately stopper with a stopper fitted with tubing so that the evolved gas

passes through calcium hydroxide TS

Acceptance criteria: A white precipitate forms.

3 ASSAY

PROCEDURE

Mobile phase: 2 g/L of sodium 1-heptanesulfonate in a 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

Sample stock solution: Nominally 5 mg/mL of aspirin prepared as follows. Transfer a quantity, equivalent to about 100 mg of aspirin from NLT 20 finely powdered Tablets, to a suitable container. Add 20.0 mL of Diluent and 10 glass beads. Shake vigorously for 10 min, and centrifuge.

Sample solution: Nominally 0.5 mg/mL of aspirin in Diluent from Sample stock solution

Chromatographic system

(See Chromatography (621), System Suitability.)

Mode: LC

Detector: UV 280 nm

Column: 4-mm x 30-cm; packing L1

Flow rate: 2 mL/min

Injection volume: 10 µL

System suitability

Sample: Standard solution

Suitability requirements

Tailing factor: NMT 2.0

Relative standard deviation: NMT 2.0%

Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of the labeled amount of aspirin (C₉H₈O₄) in the portion Tablets taken:

Result = (r_u /r_s ) × (C_s /C_u ) × 100

r_u = peak response of aspirin from the Sample solution

r_s = peak response of aspirin from the Standard solution

C_s = concentration of USP Aspirin RS in the Standard solution (mg/mL)

C_u = nominal concentration of aspirin in the Sample solution (mg/mL)

Acceptance criteria: 90.0%–110.0%

4 PERFORMANCE TESTS

Solution Time: NMT 5 min for 2 Tablets completely dissolved in 180 mL of water at 17.5 ± 2.5°.

Uniformity of Dosage Units 〈905〉: Meet the requirements

5 IMPURITIES

Limit of Free Salicylic Acid

Mobile phase, Diluent, and Chromatographic system: Proceed as directed in the Assay.

System suitability solution: 0.015 mg/mL of USP Salicylic Acid RS and 0.5 mg/mL of USP Aspirin RS in Diluent

Standard solution: 0.015 mg/mL of USP Salicylic Acid RS in Diluent

Sample solution: Use the Sample stock solution prepared as directed in the Assay.

System suitability

Samples: System suitability solution and Standard solution

[Note—The relative retention times for salicylic acid and aspirin are 0.7 and 1.0, respectively.]

Suitability requirements

Resolution: NLT 2.0 between salicylic acid and aspirin, System suitability solution

Relative standard deviation: NMT 4.0%, Standard solution

Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of salicylic acid (C₇H₆O₃) in the portion of Tablets taken:

Result = (r_u /r_s ) × (C_s /C_u ) × 100

r_u = peak response of salicylic acid from the Sample solution

r_s = peak response of salicylic acid from the Standard solution

C_s = concentration of USP Salicylic Acid RS in the Standard solution (mg/mL)

C_u = nominal concentration of aspirin in the Sample solution (mg/mL)

Acceptance criteria: NMT 8.0%

6 SPECIFIC TESTS

 Acid-Neutralizing Capacity 〈301〉: NLT 5.0 mEq of acid is consumed by 1 Tablet.

7 ADDITIONAL REQUIREMENTS

Packaging and Storage: Preserve in tight containers.

USP Reference Standards 〈11〉

USP Aspirin RS

USP Salicylic Acid RS