Dehydrocholic Acid Tablets
DEFINITION
Dehydrocholic Acid Tablets contain NLT 94.0% and NMT 106.0% of the labeled amount of C24H34O5.
IDENTIFICATION
• A. Infrared Absorption 
197K
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. [Note—Reserve a portion of the material obtained for use in Identification test B. ]
for 2 h. [Note—Reserve a portion of the material obtained for use in Identification test B. ]
• B. Melting Range or Temperature 741:
231–242, but the range between beginning and end of melting does not exceed 3.
741:
231–242, but the range between beginning and end of melting does not exceed 3.
Sample:
Use the material reserved from Identification test A.
ASSAY
• Procedure
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%
PERFORMANCE TESTS
• Disintegration 701
701
Time:
NMT 30 min
• Uniformity of Dosage Units 905:
Meet the requirements
905:
Meet the requirements
SPECIFIC TESTS
• Microbial Enumeration Tests 61 and Tests for Specified Microorganisms 62:
Meets the requirements of the test for absence of Salmonella species
61 and Tests for Specified Microorganisms 62:
Meets the requirements of the test for absence of Salmonella species
ADDITIONAL REQUIREMENTS
• Packaging and Storage:
Preserve in well-closed containers.
• USP Reference Standards 11
11
USP Dehydrocholic Acid RS 
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Auxiliary Information—
Please check for your question in the FAQs before contacting USP.
| Topic/Question | Contact | Expert Committee |
|---|---|---|
| Monograph | Elena Gonikberg, Ph.D.
Principal Scientific Liaison 1-301-816-8251 |
(SM32010) Monographs - Small Molecules 3 |
| 701 |
Margareth R.C. Marques, Ph.D.
Senior Scientific Liaison 1-301-816-8106 |
(GCDF2010) General Chapters - Dosage Forms |
| 61 |
Radhakrishna S Tirumalai, Ph.D.
Principal Scientific Liaison 1-301-816-8339 |
(GCM2010) General Chapters - Microbiology |
| 62 |
Radhakrishna S Tirumalai, Ph.D.
Principal Scientific Liaison 1-301-816-8339 |
(GCM2010) General Chapters - Microbiology |
| Reference Standards | RS Technical Services 1-301-816-8129 rstech@usp.org |
USP35–NF30 Page 2815