Ursodeoxycholic Acid (UDCA) is a naturally occurring hydrophilic bile acid used in the treatment of cholestatic liver diseases and cholesterol gallstones.
It improves bile flow, reduces bile toxicity, and protects hepatocytes. UDCA is supplied as an active pharmaceutical ingredient (API) for oral solid dosage forms used in hepatobiliary disorder therapies.
1. PRODUCT IDENTIFICATION
| Chemical Name | 3α,7β-Dihydroxy-5β-cholan-24-oic acid |
| Synonyms | UDCA |
| CAS No. | 128-13-2 |
| Molecular Formula | C₂₄H₄₀O₄ |
| Molecular Weight | 392.57 g/mol |
2. PRODUCT DESCRIPTION
Ursodeoxycholic Acid is widely used in pharmaceutical formulations for the management of primary biliary cholangitis, gallstone dissolution, and other hepatobiliary disorders by improving bile composition and flow.
3. GRADE
- Pharmaceutical Grade (API)
- Complies with USP / EP / BP specifications or customer-approved standards
4. AVAILABLE FORM
A white or almost white powder
5. TECHNICAL SPECIFICATIONS
| Description | A white or almost white powder |
| Identification | Conforms |
| Assay (dry basis) | ≥ 99.0% |
| Loss on Drying | ≤ 1.0% |
| Related Substances | As per pharmacopeial limits |
(Specifications may be customized to USP / EP / BP / IP or customer requirements.)
6. PHYSICOCHEMICAL PROPERTIES
- Solubility: Soluble in ethanol
- Stability: Stable under recommended storage conditions
7. APPLICATIONS
Pharmaceuticals- Treatment of primary biliary cholangitis (PBC)
- Dissolution of cholesterol gallstones
- Hepatobiliary disorder therapies
8. REGULATORY & COMPLIANCE
- Manufactured in GMP-certified facilities
- Complies with ICH guidelines
- Non-GMO
- BSE/TSE Free
Documentation Available:
- Certificate of Analysis (CoA)
- MSDS / SDS
- Stability data
- Manufacturing process flow (on request)
9. PACKAGING
- 5 kg double LDPE-lined HDPE drum
- 25 kg HDPE drum (bulk)
- Custom packaging available upon request
10. STORAGE & SHELF LIFE
- Store in a cool, dry place, protected from light
- Keep container tightly closed
- Shelf Life: 36 months under recommended storage conditions
11. SAFETY INFORMATION
- For commercial use only
- Avoid inhalation of dust
- Use appropriate PPE
- Refer to MSDS for detailed safety information
12. COMMERCIAL INFORMATION
- MOQ: As per regulatory and packaging requirements
- Lead Time: 7 Days
- Supply Capability: Commercial and contract supply
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