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Specifications of Ursodeoxycholic acid丨128-13-2
|
Property |
Specification |
|
Appearance |
White or off-white powder |
|
Assay (On dried basis) |
99.0% ~ 101.0% |
|
Solubility |
Freely soluble in ethanol (95%), slightly soluble in acetone, practically insoluble in methylene chloride and water |
|
Specific Optical Rotation |
+58.0° ~ +62.0° |
|
Melting Point |
About 202.0°C |
|
Identification |
|
|
IR |
Sample spectrum corresponds to that of standard spectrum: Complies |
|
TLC |
Sample and standard exhibit the same spot: Complies |
|
Colour reaction |
Complies |
|
Related Substances |
|
|
Impurity A (CDCA) |
1.0% max |
|
Any other individual impurity |
0.10% max |
|
Total impurities |
1.50% max |
|
Loss on Drying |
1.0% max |
|
Related Solvents |
|
|
Acetone |
0.5% max |
|
Ethyl acetate |
0.5% max |
|
4-Methyl-2-Pentanone |
0.45% max |
|
Triethylamine |
0.05% max |
|
Tert-Butanol |
0.1% max |
|
Impurity C |
0.10% max |
|
Residue on Ignition |
0.10% max |
|
Heavy Metals |
20 ppm max |
Transport Information of Ursodeoxycholic acid丨128-13-2
|
Parameter |
Specification |
|
UN Number |
|
|
Class |
|
|
Packing Group |
|
|
H.S. Code |
2918190090303 |
|
Stability & Reactivity |
Stable |
|
Storage |
Tightly closed. Store in a closed, dry, ventilated place |
|
Condition to Avoid |
formation of dust and aerosols |
|
Package |
Manufacturing Information of Ursodeoxycholic acid丨128-13-2
|
Parameter |
Specification |
|
Capacity |
10MT/month |
|
Frequency |
|
|
Main Export Countries |
UK, US, India |
|
Capacity/Batch |
1200kg/batch |
|
Experience |
Production since 2005 |
|
Stock |
500kg |
Introduction
Ursodeoxycholic acid丨128-13-2 is a bile acid used in the treatment of liver and gallbladder disorders. It is widely prescribed for dissolving gallstones, treating cholestatic liver diseases, and improving bile flow. UDCA also exhibits anti-inflammatory and cytoprotective properties, making it beneficial in various hepatic and metabolic conditions.
Applications of Ursodeoxycholic acid丨128-13-2
1. Treatment of Gallstones (Cholelithiasis)
Dissolves Cholesterol Gallstones:
Used as a non-surgical alternative for patients with small, cholesterol-based gallstones.
Prevention of Gallstone Formation:
Often prescribed to individuals undergoing rapid weight loss or post-bariatric surgery.
2. Management of Cholestatic Liver Diseases
Primary Biliary Cholangitis (PBC):
First-line treatment for PBC, helping to slow disease progression and improve liver function.
Primary Sclerosing Cholangitis (PSC) (Investigational Use):
Studied for its role in reducing bile duct inflammation and liver damage.
3. Liver Protection and Function Improvement
Enhances Bile Flow (Choleretic Effect):
Helps prevent toxic bile accumulation, reducing liver stress and damage.
Hepatoprotective in Drug-Induced Liver Injury:
Used in patients with chemotherapy or medication-related liver damage.
4. Cystic Fibrosis-Related Liver Disease
Improves Bile Secretion in Cystic Fibrosis Patients:
Helps reduce liver complications in individuals with cystic fibrosis.
5. Potential Use in Metabolic and Neurological Disorders
Investigated for Non-Alcoholic Fatty Liver Disease (NAFLD) and Diabetes:
May improve insulin sensitivity and reduce liver fat accumulation.
Neuroprotective Properties (Experimental Research):
Studied for potential benefits in Parkinson's disease and amyotrophic lateral sclerosis (ALS).
Benefits of Ursodeoxycholic acid丨128-13-2
1. Non-Surgical Gallstone Treatment
● Offers a safe, non-invasive alternative to gallbladder removal in some patients.
2. Liver Protective and Anti-Inflammatory
● Reduces bile toxicity, oxidative stress, and inflammation, slowing liver disease progression.
3. Enhances Bile Flow and Digestion
● Improves bile secretion and absorption of fats and fat-soluble vitamins.
4. Potential in Metabolic and Neurodegenerative Disorders
● Under research for diabetes, fatty liver disease, and neurodegeneration.
Conclusion
Ursodeoxycholic acid丨128-13-2 is a clinically important bile acid widely used for treating gallstones, liver diseases, and bile flow disorders. Its hepatoprotective, anti-inflammatory, and bile-regulating properties make it essential in gastroenterology and hepatology. Ongoing research suggests potential applications in metabolic and neurological conditions, expanding its therapeutic importance.
