Dehydrocholic Acid Tablets
» Dehydrocholic Acid Tablets contain not less than 94.0 percent and not more than 106.0 percent of the labeled amount of C24H34O5.
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 enumeration tests 61 and Tests for specified microorganisms 62 Tablets meet the requirements of the test for absence of Salmonella species.
Disintegration 701: 30 minutes.
Uniformity of dosage units 905: meet the requirements.
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 C24H34O5.
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USP32NF27 Page 2063