Ursodeoxycholic Acid Powder Cas No.128-13-2
Product Source: Synthetic
Product Specification: ≥99%
CAS No.: 128-13-2
Molecular Formula: C₂₄H₄₀O₄
Molecular Weight: 392.57 g/mol
Testing Method: HPLC
Active Ingredient: Ursodeoxycholic Acid
Product Characteristics: White or off-white crystalline powder.
Product Packaging: 1kg/bag; 25kg/drum, customizable
Storage Conditions: Store sealed, protected from light, in a cool, dry place (recommended storage temperature 2-8°C).
Shelf Life: 24 months
What is Ursodeoxycholic Acid API (CAS 128-13-2)?
High-Purity Ursodeoxycholic Acid API | CAS 128-13-2
Ursodeoxycholic Acid (CAS No. 128-13-2), commonly referred to as UDCA, is a naturally occurring hydrophilic bile acid and a critical Active Pharmaceutical Ingredient (API) for hepatobiliary therapeutics. Manufactured via advanced synthetic processes at Xi'an Tihealth, our UDCA crystalline powder achieves a superior HPLC purity of ≥99.0%. Specifically developed to displace toxic hydrophobic bile acids, it serves as the first-line treatment for primary biliary cholangitis (PBC) and cholesterol gallstone dissolution. This pharmaceutical-grade API strictly adheres to USP, EP, and ChP monographs, ensuring exceptionally low levels of lithocholic acid (LCA) and other process-related impurities for high-specification oral solid dosage production.
What are the core technical specifications?
| Parameter | Product Specification |
|---|---|
| Chemical Name | 3α,7β-Dihydroxy-5β-cholan-24-oic acid |
| CAS Number | 128-13-2 |
| Molecular Formula | C₂₄H₄₀O₄ |
| Molecular Weight | 392.57 g/mol |
| Assay (HPLC, Dried Basis) | ≥ 99.0% |
| Storage Conditions | 2-8°C, sealed, protected from light |
| Source | Synthetic (BSE/TSE-Free) |
What is the pharmacological mechanism of action?
Ursodeoxycholic Acid facilitates hepatoprotection and cholestasis relief through a multi-targeted pathway:
- Cholesterol Dissolution: UDCA reduces the cholesterol saturation index of bile by inhibiting intestinal absorption and hepatic secretion of cholesterol, promoting the gradual dissolution of radiolucent cholesterol gallstones.
- Cytoprotective Displacement: By increasing the pool of hydrophilic bile acids, UDCA competitively replaces endogenous, toxic hydrophobic bile acids (such as Lithocholic Acid and Deoxycholic Acid), thereby stabilizing hepatocyte membranes and preventing bile acid-induced apoptosis.
- Immunomodulatory & Cholagogue Effects: It stimulates the secretion of bile through activation of the hepatocyte transport system and downregulates the abnormal expression of MHC Class I and II antigens, reducing autoimmune-mediated biliary damage.
What are the primary pharmaceutical applications?
- PBC First-Line Therapy: The essential API for manufacturing 250mg or 500mg tablets indicated for Primary Biliary Cholangitis.
- Lithotripsy Support: Utilized in formulations designed for gallstone prevention in patients undergoing rapid weight loss or as an adjunct to lithotripsy.
- Pediatric Hepatology: Applied in developing oral suspensions for chronic cholestatic conditions in pediatric populations.
Compliance & Storage Notice: This product is intended strictly for industrial formulation or pharmaceutical R&D. Storage at 2-8°C is mandatory to maintain crystalline stability and prevent oxidative degradation of the bile acid core.
Frequently Asked Questions (FAQ)
No. Xi'an Tihealth provides 100% synthetic UDCA API. This ensures a BSE/TSE-free profile, eliminates viral contamination risks associated with animal-derived bile, and provides a much higher level of batch-to-batch consistency and purity required for modern pharmaceutical manufacturing.
How do you control the levels of Lithocholic Acid (LCA) in the API?
Lithocholic Acid is a hepatotoxic impurity. We utilize multi-stage purification and validated HPLC methodology to ensure that individual unknown impurities remain below 0.1% and specific toxic bile acid analogues are strictly controlled within USP/EP limits.
What is the impact of particle size on UDCA formulation performance?
UDCA has poor aqueous solubility. We can provide API with customized particle size distribution (PSD) or micronized grades to enhance dissolution rates and systemic bioavailability in oral solid dosage forms, supporting the development of bioequivalent generic drugs.
Why is 2-8°C storage recommended for this API powder?
While UDCA is chemically robust, refrigeration (2-8°C) minimizes the risk of polymorphic transformation and oxidative stress. This ensures the API remains a white, free-flowing crystalline powder with a stable assay for the full 24-month shelf life.
Does Xi'an Tihealth provide documentation for regulatory submissions?
Yes. We provide a comprehensive technical data package, including the Certificate of Analysis (COA), Method of Analysis (MOA), Stability Data, and MSDS. Our quality team is ready to support your GMP audits and regulatory filings (CEP/DMF support).
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