Dehydrocholic Acid
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This article is compiled based on the United States Pharmacopeia (USP) – 2025 Edition
Issued and maintained by the United States Pharmacopeial Convention (USP)
C24H34O5 402.52
Cholan-24-oic acid, 3,7,12-trioxo-, (5β)-;
3,7,12-Trioxo-5β-cholan-24-oic acid CAS RN®: 81-23-2; UNII: NH5000009I.
1 DEFINITION
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°.
2 IDENTIFICATION
Change to read:
A. Spectroscopic Identification Tests 〈197〉, Infrared Spectroscopy: 197K
3 ASSAY
3.1 Procedure
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
4 IMPURITIES
4.1 Residue on Ignition 〈281〉: NMT 0.3%
4.2 Barium
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.
5 SPECIFIC TESTS
5.1 Melting Range or Temperature 〈741〉
231°-242°, but the range between beginning and end of melting does not exceed 3°.
5.2 Optical Rotation, Specific Rotation 〈781S〉
+29.0° to +32.5°
Sample solution: 20 mg/mL in dioxane
5.3 Loss on Drying 〈731〉
Dry at 105° for 2 h: it loses NMT 1.0% of its weight.
5.4 Microbial Enumeration Tests 〈61〉 and Tests for Specified Microorganisms 〈62〉
It meets the requirements of the test for absence of Salmonella species.
5.5 Odor on Boiling
Boil 2 g with 100 mL of water for 2 min: the mixture is odorless.
6 ADDITIONAL REQUIREMENTS
Packaging and Storage: Preserve in well-closed containers.
USP Reference Standards 〈11〉
USP Dehydrocholic Acid RS
