Dehydrocholic Acid Tablets
Dehydrocholic Acid Tablets contain NLT 94.0% and NMT 106.0% of the labeled amount of C24H34O5.
• A. Infrared Absorption 197K
Sample: Mix a quantity of finely powdered Tablets equivalent to 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 h. [NoteReserve a portion of the material obtained for use in Identification test B. ]
• B. Melting Range or Temperature 741: 231242, but the range between beginning and end of melting does not exceed 3.
Sample: Use the material reserved from Identification test A.
Sample: Finely powder NLT 20 Tablets. Transfer a portion of the powder equivalent to 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 min. Allow to cool.
Analysis: Add phenolphthalein TS and 20 mL of water. 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: 94.0%106.0%
• Disintegration 701
Time: NMT 30 min
• Uniformity of Dosage Units 905: Meet the requirements
• Microbial Enumeration Tests 61 and Tests for Specified Microorganisms 62: Meets the requirements of the test for absence of Salmonella species
• Packaging and Storage: Preserve in well-closed containers.
• USP Reference Standards 11
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USP35NF30 Page 2815