Packaging and storage— Preserve in well-closed containers.

Identification— Mix a quantity of finely powdered Tablets,equivalent to about 500mg of dehydrocholic acid,with 15mLof water,and add slowly,with stirring,2mLof sodium carbonate TS.Filter,and add to the filtrate 3Nhydrochloric acid (about 2mL),dropwise,until no more precipitate is formed.Filter the precipitate,wash with small portions of cold water until free from chloride,and dry at 105for 2hours:the dehydrocholic acid so obtained responds to the Identificationtest and meets the requirements of the test for Melting rangeunder Dehydrocholic Acid.

Microbial limits á61ñ— Tablets meet the requirements of the test for absence of Salmonellaspecies.

Disintegration á701ñ: 30minutes.

Uniformity of dosage units á905ñ: meet the requirements.

Assay— Weigh and finely powder not less than 20Tablets.Transfer an accurately weighed portion of the powder,equivalent to about 500mg of dehydrocholic acid,to a 300-mLconical flask,add 60mLof neutralized alcohol,and warm on a steam bath for 10minutes.Cool,add phenolphthalein TSand 20mLof water,and titrate with 0.1Nsodium hydroxide VS,adding 100mLof water shortly before the endpoint is reached.Each mLof 0.1Nsodium hydroxide is equivalent to 40.25mg of C24H34O5.

Expert Committee:(PA4)Pharmaceutical Analysis 4

USP28–NF23Page 576

Phone Number:1-301-816-8251