Ursodeoxycholic Acid (UDCA) – CAS:128-13-2
High Purity Bile Acid API for Hepatology Formulations
What Is Ursodeoxycholic Acid (UDCA)?
Ursodeoxycholic Acid (UDCA), also known as ursodiol, is a synthetic and naturally derived bile acid extensively utilized in hepatology. Classified under bile acid derivatives, this active pharmaceutical ingredient (API) is essential in formulating drugs for liver and gallbladder disorders. Its structural formula C₂₄H₄₀O₄ and CAS number 128-13-2 make it a well-referenced compound across pharmacopeial standards including EP, USP, and JP.
At Pharmint, we offer high-purity UDCA manufactured under strict GMP compliance, suitable for large-scale formulations, research pipelines, and international regulatory submissions.
Commercial & Clinical Applications
UDCA is a globally recognized hepatoprotective API, with multiple therapeutic applications:
- Formulation of oral tablets and capsules for treating Primary Biliary Cholangitis (PBC) – one of the only FDA-approved bile acids for this indication.
- Supportive treatment for cholestatic liver diseases, particularly where bile acid flow modulation is clinically warranted.
- Dissolution of radiolucent gallstones, reducing the need for surgical interventions in select patient populations.
- Investigated as an adjuvant compound in metabolic, inflammatory, and neurodegenerative disorders—opening future API demand in emerging therapeutic categories.
Why Procure UDCA from Pharmint?
Procurement professionals and sourcing managers choose Pharmint for our focus on quality, traceability, and export readiness:
- GMP-Certified API Manufacturing: Produced under cGMP with full traceability to meet regulatory expectations across Europe, Asia, LATAM, and North America.
- Documentation Suite: Full compliance documents including COA, MSDS, DMF (where available), and TSE/BSE-free declarations.
- Custom Sizing & Packaging: Scalable supply from sample packs for R&D to commercial-scale lots (1 kg to 100+ kg) with pharma-grade packaging solutions.
- Regulatory Support: CEP/US-DMF availability from partner plants; support with product registration dossiers.
- Dedicated Export Logistics: Secure, temperature-monitored global shipping with IATA/IMDG classification handling as required.
Technical Specifications
| Property | Value |
| CAS No. | 128-13-2 |
| Molecular Formula | C₂₄H₄₀O₄ |
| Molecular Weight | 392.57 g/mol |
| Appearance | White to off-white crystalline powder |
| Purity | ≥ 97% (HPLC/GC available) |
| Grade | Pharmaceutical / GMP |
| Shelf Life | 36 months under recommended storage |
Storage & Handling
To maintain API integrity, UDCA should be stored in tightly sealed, inert containers under cool and dry conditions (ideally 2–8 °C). Pharmint provides packaging in line with EP/USP storage standards to prevent degradation during transit and storage.
Regulatory & Shipping Support
UDCA is subject to local API registration requirements. Pharmint supports global shipping with:
- End-use declarations & compliance docs
- Customs paperwork for bulk API import/export
- GDP-compliant cold chain (if required)
Who Should Source This API?
- Pharmaceutical Formulators seeking bile acid APIs for hepatology pipeline products.
- CDMOs / CMOs developing softgel, oral tablet, or capsule formulations.
- Nutraceutical or research firms exploring liver-protective or metabolic interventions.
- Importers / Distributors needing reliable, compliant suppliers for high-volume API trade.
Ursodeoxycholic Acid FAQs
What is Ursodeoxycholic Acid used for?
Ursodeoxycholic Acid is used for treating primary biliary cholangitis, dissolving gallstones, and managing cholestatic liver conditions by promoting bile flow and reducing cytotoxic bile acids in hepatocytes.
Can Ursodeoxycholic Acid be exported under standard API trade licenses?
Yes, Ursodeoxycholic Acid can be exported under valid API trade licenses when supported by GMP certification, COA, MSDS, and end-use declarations for regulatory compliance in destination countries.
Is Ursodeoxycholic Acid classified as a controlled substance for international shipment?
Ursodeoxycholic Acid is not classified as a controlled substance but may require documentation for regulated handling depending on the import country’s API policies and health authority guidelines.
What documents are required for bulk purchasing Ursodeoxycholic Acid?
Bulk UDCA procurement requires COA, MSDS, TSE/BSE statement, GMP declaration, and often a Drug Master File (DMF) or CEP for market registration or product development support.
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