● Ursodeoxycholic acid is used to increase the secretion of bile acids and to change the composition of bile, lowering cholesterol and cholesterol lipids in bile and facilitating the gradual dissolution of cholesterol in gallstones.
● Ursodeoxycholic acid is used for the treatment of gallstones, cholestatic liver disease, fatty liver, various types of hepatitis, toxic liver disorders, cholecystitis, cholangitis and biliary dyspepsia, bile reflux gastritis, eye diseases, etc.
|Test item||Test standard||Test result|
|Appearance||White or almost white crystalline powder,taste bitter, without stink.||Complied|
|Related Substance||Lithocholic Acid ≤0.1% Cholic Acid ≤0.5%Chenodeoxycholic Acid ≤1.0%Unidentified Impurity ≤0.25% Total Impurity ≤2.0%||Complied|
|Specific Optical Rotation||+58°- +62°||+59.3°|
|Melting Point||200℃ -204℃||202.8℃-203.8℃|
|Loss on Drying||≤ 1.0％||0.3％|
|Ignition Residue||≤ 0.1％||0.07％|
|Assay (TITRATION)||≥ 99.2％—101％||99.4％|
|Heavy Mental||≤ 10ppm||Complied|
|Microorganism||Aerobic Bacteria Amount ≤ 1000cfu/gMould and Yeast Amount ≤ 100cfu/g||Aerobic Bacteria Amount ≤ 100cfu/gMould and Yeast Amount ≤ 10cfu/g|
|Conclusion: This article Ursodeoxycholic acid is in conformity with EP6.0.|