(dee hye'' droe koe' lik as' id).
Cholan-24-oic acid, 3,7,12-trioxo-, (5)-;
3,7,12-Trioxo-5-cholan-24-oic acid [81-23-2].
Dehydrocholic Acid contains NLT 98.5% and NMT 101.0% of C24H34O5, calculated on the dried basis. Dehydrocholic Acid for parenteral use melts between 237 and 242.
Sample solution: Transfer 500 mg of Dehydrocholic Acid to a 300-mL conical flask, add 60 mL of neutralized alcohol, and warm on a steam bath until dissolved. Allow to cool.
Analysis: Add phenolphthalein TS and 20 mL of water to the Sample solution. 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.
Acceptance criteria: 98.5%101.0% on the dried basis
• Residue on Ignition 281: NMT 0.3%
Sample: 2 g
Analysis: Boil the Sample with 100 mL of water for 2 min. Add 2 mL of hydrochloric acid, and again boil for 2 min. 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.
Acceptance criteria: No turbidity is produced.
• Heavy Metals, Method II 231: 20 ppm
• Melting Range or Temperature 741: 231242, but the range between beginning and end of melting does not exceed 3.
• Optical Rotation, Specific Rotation 781S: +29.0 to +32.5
Sample solution: 20 mg/mL in dioxane
• Loss on Drying 731: Dry at 105 for 2 h: it loses NMT 1.0% of its weight.
• Microbial Enumeration Tests 61 and Tests for Specified Microorganisms 62: It meets the requirements of the test for absence of Salmonella species.
• Odor on Boiling: Boil 2 g with 100 mL of water for 2 min: the mixture is odorless.
• Packaging and Storage: Preserve in well-closed containers.
• USP Reference Standards 11
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