Aspirin Effervescent Tablets for Oral Solution, chemical structure, molecular formula, Reference Standards

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 90.0percent and not more than 110.0percent of the labeled amount of aspirin (C9H8O4).

Packaging and storage— Preserve in tight containers.

USP Reference standards á11ñ— USP Aspirin RS.USP Salicylic Acid RS.

Identification—

A: Dissolve 1Tablet in about 50mLof 1Nhydrochloric acid,boil for about 5minutes,and allow to cool.To 2mLof the resulting solution add 2or 3drops of ferric chloride TS:a violet-red color is produced.

B: Add about one-half a Tablet to 50mLof 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 180mLof water at 17.5±2.5

within 5minutes.

Uniformity of dosage units á905ñ: meet the requirements.

Acid-neutralizing capacity á301ñ: not less than 5.0mEq of acid is consumed by 1Tablet.

Limit of free salicylate— Proceed as directed for Limit of free salicylic acidunder Buffered Aspirin Tablets:not more than 8.0%is found.

Assay— Proceed as directed in the Assayunder Buffered Aspirin Tablets.

Auxiliary Information— Staff Liaison:Clydewyn M.Anthony,Ph.D.,Scientist

Expert Committee:(PA2)Pharmaceutical Analysis 2

USP28–NF23Page 185

Phone Number:1-301-816-8139