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What is CAS 128-13-2 Ursodeoxycholic acid Powder?
Product Name: |
Ursodeoxycholic acid |
CAS: |
128-13-2 |
MF: |
C24H40O4 |
MW: |
392.57 |
EINECS: |
204-879-3 |
Ursodeoxycholic acid is a chemical agent of natural bile acid which is isolated from the bile of bear. It is the stereo-isomer of chenodeoxycholic acid. It has a similar litholysis effect, efficacy as chenodeoxycholic acid. However, it has a short course of treatment and a small dose. It is bound with taurine in the bile in vivo, and is a hydrophilic bile acids as well as a dissolving agent of cholesterol. It can reduce the secretion of cholesterol in the liver, lower the saturation content of cholesterol in bile, promote the secretion of bile acids, and increase the solubility of cholesterol in the bile so that cholesterol gallstones can be dissolved or prevented. Moreover, it can increase the secretion amount of bile, and have a choleretic effect by relaxing the bile duct mouth sphincter which smoothen the discharge of calculus. This product, however, cannot dissolve other types of gallstones. Ursodeoxycholic acid is useful in the treatment of cholesterol stones, hyperlipidemia, bile secretion disorders, primary biliary cirrhosis, chronic hepatitis, bile reflux gastritis and prevention of liver allograft rejection and reaction. The calculus-dissolving effect of this product is slightly weaker than the CDCA.
Items |
Specifications |
Result |
Appearance |
White or almost white crystalline powder |
Conforms |
Melting Point |
200ºC~205ºC |
202.5~203.5ºC |
Specific Optical Rotation |
+57°~+62° |
+60.5° |
Ursodeoxycholic Acid |
Comparable IR absorption with the reference. |
Conforms |
Loss on drying |
≤0.5% |
0.06% |
Sulphated ash |
≤0.1% |
0.03% |
Residual solvents |
Aceton e≤0.5% |
0.12% |
Methano l≤0.3% |
Not Detected |
Content of C24H40O4 |
98.5%~101.5% (on the dried basis) |
99.73% |
Related substance |
Lithocholic acid: ≤0.05% |
Conform |
Chenodeoycholic Acid: ≤1.5% |
Conform |
Any other single impurity: ≤0.1% |
Conform |
Conclusion |
The product complies with the specification described USP41. |
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