Dehydrocholic Acid
;)
Cholan-24-oic acid,3,7,12-trioxo-,(5b)-.
3,7,12-Trioxo-5b-cholan-24-oic acid [81-23-2].
»Dehydrocholic Acid contains not less than 98.5percent and not more than 101.0percent 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.
Identification,Infrared Absorption á197Kñ.
Melting range á741ñ:
between 231and 242,but the range between beginning and end of melting does not exceed 3.
and 242,but the range between beginning and end of melting does not exceed 3.
Specific rotation á781Sñ:
between +29.0and +32.5.
and +32.5.
Test solution:
20mg per mL,in dioxane.
Microbial limits á61ñ—
It meets the requirements of the test for absence of Salmonellaspecies.
Loss on drying á731ñ—
Dry it at 105for 2hours:it loses not more than 1.0%of its weight.
for 2hours:it loses not more than 1.0%of its weight.
Residue on ignition á281ñ:
not more than 0.3%.
Odor on boiling—
Boil 2g with 100mLof water for 2minutes:the mixture is odorless.
Barium—
Add to the mixture obtained in the test for Odor on boiling2mLof hydrochloric acid,and again boil for 2minutes.Cool,filter,and wash the filter with water until the filtrate measures 100mL.To 10mLof the filtrate add 1mLof 2Nsulfuric acid:no turbidity is produced.
Heavy metals,Method IIá231ñ:
0.002%.
Organic volatile impurities,Method Vá467ñ:
meets the requirements.
Solvent—
Use dimethyl sulfoxide.
Assay—
Transfer about 500mg of Dehydrocholic Acid,accurately weighed,to a 300-mLconical flask,add 60mLof neutralized alcohol,and warm on a steam bath until solution is effected.Cool,add phenolphthalein TSand 20mLof water,and titrate with 0.1Nsodium hydroxide VS,adding 100mLof water shortly before the endpoint is reached.Each mLof 0.1Nsodium hydroxide is equivalent to 40.25mg of C24H34O5.
Auxiliary Information—
Staff Liaison:Elena Gonikberg,Ph.D.,Scientist
Expert Committee:(PA4)Pharmaceutical Analysis 4
USP28–NF23Page 576
Phone Number:1-301-816-8251