CAS · 128-13-2
Product Overview
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.
Product Specifications
| 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 |
Applications
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
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.
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