Packaging and storage
Preserve in well-closed containers.
Identification
Mix a quantity of finely powdered Tablets, equivalent to about 500 mg of dehydrocholic acid, with 15 mL of water, and add slowly, with stirring, 2 mL of
sodium carbonate TS. Filter, and add to the filtrate 3 N hydrochloric acid (about 2 mL), dropwise, until no more precipitate is formed. Filter the precipitate, wash with small portions of cold water until free from chloride, and dry at 105
for 2 hours: the dehydrocholic acid so obtained responds to the
Identification test and meets the requirements of the test for
Melting range under
Dehydrocholic Acid.
Microbial limits 61
Tablets meet the requirements of the test for absence of
Salmonella species.
Assay
Weigh and finely powder not less than 20 Tablets. Transfer an accurately weighed portion of the powder, equivalent to about 500 mg of dehydrocholic acid, to a 300-mL conical flask, add 60 mL of neutralized alcohol, and warm on a steam bath for 10 minutes. Cool, add
phenolphthalein TS and 20 mL of water, and titrate with 0.1 N sodium hydroxide VS, adding 100 mL of water shortly before the endpoint is reached. Each mL of 0.1 N sodium hydroxide is equivalent to 40.25 mg of C
24H
34O
5.