Cholan-24-oic acid, 3,7,12-trioxo-, (5)-.
3,7,12-Trioxo-5-cholan-24-oic acid [81-23-2].
» Dehydrocholic Acid contains not less than 98.5 percent and not more than 101.0 percent of C24H34O5, calculated on the dried basis. Dehydrocholic Acid for parenteral use melts between 237 and 242.
Packaging and storage Preserve in well-closed containers.
Melting range 741: between 231 and 242, but the range between beginning and end of melting does not exceed 3.
Specific rotation 781S: between +29.0 and +32.5.
Test solution: 20 mg per mL, in dioxane.
Microbial enumeration tests 61 and Tests for specified microorganisms 62 It meets the requirements of the test for absence of Salmonella species.
Loss on drying 731 Dry it at 105 for 2 hours: it loses not more than 1.0% of its weight.
Residue on ignition 281: not more than 0.3%.
Odor on boiling Boil 2 g with 100 mL of water for 2 minutes: the mixture is odorless.
Barium Add to the mixture obtained in the test for Odor on boiling 2 mL of hydrochloric acid, and again boil for 2 minutes. Cool, filter, and wash the filter with water until the filtrate measures 100 mL. To 10 mL of the filtrate add 1 mL of 2 N sulfuric acid: no turbidity is produced.
Heavy metals, Method II 231: 0.002%.
Assay Transfer about 500 mg of Dehydrocholic Acid, accurately weighed, to a 300-mL conical flask, add 60 mL of neutralized alcohol, and warm on a steam bath until solution is effected. 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
Chromatographic columns text is not derived from, and not part of, USP 32 or NF 27.