Dehydrocholic Acid
402.52Cholan-24-oic acid, 3,7,12-trioxo-, (5
)-.
3,7,12-Trioxo-5
-cholan-24-oic acid
[81-23-2].» Dehydrocholic Acid contains not less than 98.5 percent and not more than 101.0 percent of C24H34O5, calculated on the dried basis. Dehydrocholic Acid for parenteral use melts between 237
and 242.
and 242.
Packaging and storage—
Preserve in well-closed containers.
Melting range 
741
:
between 231 and 242, but the range between beginning and end of melting does not exceed 3.
741:
between 231 and 242, but the range between beginning and end of melting does not exceed 3.
Microbial enumeration tests 61 and Tests for specified microorganisms 62—
It meets the requirements of the test for absence of Salmonella species.
61 and Tests for specified microorganisms 62—
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.
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%.
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%.
231:
0.002%.
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.
Auxiliary Information—
Please check for your question in the FAQs before contacting USP.
Chromatographic Column—
| Topic/Question | Contact | Expert Committee |
| Monograph | Elena Gonikberg, Ph.D.
Senior Scientist 1-301-816-8251 |
(MDGRE05) Monograph Development-Gastrointestinal Renal and Endocrine |
| Reference Standards | Lili Wang, Technical Services Scientist 1-301-816-8129 RSTech@usp.org |
|
| 61 |
Radhakrishna S Tirumalai, Ph.D.
Senior Scientist 1-301-816-8339 |
(MSA05) Microbiology and Sterility Assurance |
| 62 |
Radhakrishna S Tirumalai, Ph.D.
Senior Scientist 1-301-816-8339 |
(MSA05) Microbiology and Sterility Assurance |
USP32–NF27 Page 2063
Chromatographic columns text is not derived from, and not part of, USP 32 or NF 27.