C24H34O5 402.52

Cholan-24-oic acid, 3,7,12-trioxo-, (5)-.
3,7,12-Trioxo-5-cholan-24-oic acid [81-23-2].

Packaging and storage— Preserve in well-closed containers.

USP Reference standards 11— USP Dehydrocholic Acid RS.

Identification, Infrared Absorption 197K.

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.

Microbial limits 61— 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%.

Organic volatile impurities, Method V 467: meets the requirements.

Residual solvents 467: meets the requirements.

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.

Expert Committee : (MDGRE05) Monograph Development-Gastrointestinal Renal and Endocrine

USP29–NF24 Page 627

Phone Number : 1-301-816-8251