Aspirin Effervescent Tablets for Oral Solution
» 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 not less than 90.0 percent and not more than 110.0 percent of the labeled amount of aspirin (C9H8O4).
Packaging and storage— Preserve in tight containers.
Identification—
A: Dissolve 1 Tablet in about 50 mL of 1 N hydrochloric acid, boil for about 5 minutes, and allow to cool. To 2 mL of the resulting solution add 2 or 3 drops of ferric chloride TS: a violet-red color is produced.
B: Add about one-half a Tablet 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: a white precipitate forms.
Solution time— Two Tablets dissolve completely in 180 mL of water at 17.5 ± 2.5 within 5 minutes.
Uniformity of dosage units 905: meet the requirements.
Acid-neutralizing capacity 301: not less than 5.0 mEq of acid is consumed by 1 Tablet.
Limit of free salicylate— Proceed as directed for Limit of free salicylic acid under Buffered Aspirin Tablets: not more than 8.0% is found.
Assay— Proceed as directed in the Assay under Buffered Aspirin Tablets.
Auxiliary Information— Please check for your question in the FAQs before contacting USP.
Topic/Question Contact Expert Committee
Monograph Clydewyn M. Anthony, Ph.D.
Scientist
1-301-816-8139
(MDCCA05) Monograph Development-Cough Cold and Analgesics
Reference Standards Lili Wang, Technical Services Scientist
1-301-816-8129
RSTech@usp.org
USP32–NF27 Page 1588
Chromatographic Column—
Chromatographic columns text is not derived from, and not part of, USP 32 or NF 27.