Ursodeoxycholic acid 128-13-2 Digestive system Cholagogic
Payment: T/T, L/C
Product Origin: China
Shipping Port: Beijing/Shanghai/Hangzhou
Production capacity: 2000kg/month
Order(MOQ): 25kg
Lead Time: 3 Working Days
Storage condition: Stored in cool, dry place, room temperature.
Package material: drum
Package size: 25kg/drum
Safety information: Not dangerous goods
Introduction
Ursodeoxycholic acid (UDCA), also known as ursodiol, is a secondary bile acid, produced in humans and most other species from metabolism by intestinal bacteria. It is synthesized in the liver in some species, and was first identified in bear bile, which is the derivation of its name Ursus. In purified form, it has been used to treat or prevent several diseases of the liver or bile ducts.
UDCA has been used as medical therapy in gallstone disease (cholelithiasis) and for biliary sludge. UDCA helps reduce the cholesterol saturation of bile and leads to gradual dissolution of cholesterol-rich gallstones.
UDCA may be given after bariatric surgery to prevent cholelithiasis, which commonly occurs due to the rapid weight loss producing biliary cholesterol oversaturation and also biliary dyskinesia secondary hormonal changes.
Specification (EP10)
|
Item |
Specification |
|
Appearance |
White or almost white powder |
|
Solubility |
Practically insoluble in water, freely soluble in ethanol (96%), slightly soluble in acetone, practically insoluble in methylene chloride |
| Melting point |
202-204℃ |
|
Identification |
Same IR spectrum as ursodeoxycholic acid CRS |
| The principal spot in the chromatogram obtained with the test solution (b) is similar in position, colour and size to the principle spot in the chromatogram obtained with reference solution (a). | |
| The suspension obtained is greenish-blue. | |
| Specific optical rotation |
+58.0~+62.0° |
| Impurity C |
Lithocholic acid ≤ 0.1% |
| Related substance (HPLC) |
impurity A: chenodeoxycholic acid ≤ 1.0% |
|
unspecified impurities ≤ 0.1% |
|
|
total ≤ 1.5% |
|
| Heavy metals |
ICH Q3D |
|
Loss on drying |
≤ 1.0% |
| Sulphated ash |
≤ 0.1% |
| Assay |
99.0%~101% (Dried substance) |
| Residual solvents |
Acetone ≤ 5000 ppm Ethyl acetate ≤ 5000 ppm Isopropanol ≤ 5000 ppm Ethanol ≤ 5000 ppm |
| Microbiological Tests |
Total aerobic microbial count ≤ 10³CFU/g Total yeasts and moulds count ≤ 10²CFU/g Escherichia coli: Absent in 1 g Salmonella: Absent in 10 g |
| Additional properties | |
| Particle size distribution |
100% pass number 180 sieve (100% pass 80 mesh sieve) |
