Ursodeoxycholic acid UDCA Ursodiol
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Specifications
Item |
Limit |
|
Appearance |
White or almost white powder, taste bitter, without stink. |
|
Solubility |
Almost insoluble in water; soluble in methanol and in glacial acetic acid;slightly soluble in chloroform. |
|
Identification |
IR spectrum: Identical with reference spectrum |
|
Specific Optical Rotation |
+58°~ +62° |
|
Chloride |
≤0.02% |
|
Sulfate |
≤0.05% |
|
Arsenic Salt |
≤2ppm |
|
Barium Salt |
None |
|
Melting point |
200°C~204°C |
|
Loss on drying |
≤1.0% |
|
Ignition Residue |
≤0.1% |
|
Heavy metal |
≤10ppm |
|
Assay(Titration) |
99%~101.0% |
|
Related Substances(TLC) |
|
|
Chenodeoxycholic acid |
|
|
Lithocholic acid |
|
|
Cholic acid |
≤1.0% |
|
Unidentified |
≤0.5% |
|
Total Impurity |
≤0.25% |
Indications of ursodeoxycholic acid: for the prevention treatment of cholesterol stone caused by cholecystitis, cholangitis,
Biliary dyspepsia, jaundice, so on. Also can be used facuteonic hepatitis, hyperlipidemia, ileal lesions caused by steatorrhea,
Bile reflux gastritis.
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