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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.
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.
Residual solvents 467: meet the requirements.
(Official January 1, 2007)
Assay— Proceed as directed in the Assay under Buffered Aspirin Tablets.
Auxiliary Information— Staff Liaison : Clydewyn M. Anthony, Ph.D., Scientist
Expert Committee : (MDCCA05) Monograph Development-Cough Cold and Analgesics
USP29–NF24 Page 202
Phone Number : 1-301-816-8139