Ursodiol, also known as ursodeoxycholic acid and the abbreviation UDCA, is one of the secondary bile acids, which are metabolic byproducts of intestinal bacteria.
CAS NO: 128-13-2
Molecular Formula: C24H40O4
Molecular Weight: 392.58
Function: Use of ursodeoxycholic acid in patients with liver disease, reduces cholesterol absorption and dissolve gallstones.
Certificate of Analysis, EP5 Edition,
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Item |
Standard (EP5) |
Test Result |
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Characteristics |
White or almost white powder |
Complies |
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Solubility |
Very slightly soluble in water. freely soluble in alcohol |
Complies |
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slightly soluble in cetone and in methylene chloride |
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Identification |
IR,TLC and chrominance test |
Complies |
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Melting Point |
About |
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Specific Optical Rotation |
［α］D20: +58.0°~ +62.0° |
+59.8° |
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Heavy metals |
≤20 PPM |
Complies |
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Loss on drying |
≤1.0% |
0.22% |
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Sulphated ash |
≤0.1% |
0.05% |
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Assay (Titration) |
99.0 %～101.0% (waterless) |
99.40% |
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Related substance(TLC) |
Lithocholic acid: ≤0.1% |
Complies |
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Cholic acid:≤0.5% |
Complies |
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CDCA: ≤1.0% |
Complies |