128-13-2 UDCA Ursodeoxycholic Acid
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Test item |
Test standard |
Test result |
Appearance |
White powder. |
Complies |
Solubility |
Very slightly soluble in water,freely soluble in alcohol. |
Comlpies |
Identification |
IR spectrum :identical with reference spectrum. |
Complies |
Chloride |
0.02% |
Complies |
Sulfate |
0.05% |
Complies |
Arsenic salt |
2ppm |
Complies |
Barium salt |
None |
Complies |
Specific optical rotation |
+58° - +62° |
+60.5° |
Melting point |
200°C -204°C |
201.1°C—203.8°C |
Loss on drying |
Not more than 1.0% |
0.09% |
Ignition residue |
Not more than 0.1% |
0.014% |
Heavy mental |
Not more than 10ppm |
Complies |
Assay (Titration) |
99%——101% |
99.4% |
Related substance(TLC) Chenodeoxycholie acid Lithochollc acid Cholic acid Unidentified |
Not more than1.0% Not more than0. 1% Not more than0.5% Not more than0.25% |
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