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| Product information |
Product name | Ursodeoxycholic Acid |
CAS No. | 128-13-2 |
Molecular Formula | C24H40O4 |
Molecular Weight | 392.57 |
Quality Standard | CEP,EP,11,USP43,JP18,CP2020 ,WC,DMF |
Appearance | White or off-white crystalline powder |
| COA Of Ursodeoxycholic Acid |
| Item | Specification | Results |
|---|---|---|
| Appearance | A white to light yellow powder | Conforms |
| Solubility | Insoluble in water, insoluble in methylene chloride, freely soluble in ethanol, soluble in ethanol, slightly soluble in acetone. | Conforms |
| Identification | IR | Conforms |
| Melting point | 200-204 °C | 202-204 °C |
| Loss on drying | ≤ 1.0% | 0.75% |
| Specific optical rotation | +59.8° - +62.0° | +59.5° |
| Sulphated Ash | ≤ 0.10% | 0.06% |
| Heavy metals | ≤ 20 ppm | 12 ppm |
| Burned residue | ≤ 0.10% | 0.07% |
| Chloride | ≤ 0.10% | 0.06% |
| Related substances (by HPLC) | ||
| Chenodeoxycholic acid | ≤ 1.00% | 0.15% |
| Lithocholic acid | ≤ 0.10% | 0.01% |
| Single impurity | ≤ 0.10% | 0.05% |
| Total impurities | ≤ 0.15% | 0.45% |
| Residual solvent | ||
| Isopropanol | ≤ 0.50% | None |
| Methanol | ≤ 0.30% | 0.14% |
| Acetone | ≤ 0.50% | 0.12% |
| Ethyl acetate | ≤ 0.50% | 0.06% |
| Assay | 99% - 102% | 99.52% |
| Conclusion | The sample conforms to standard |
Ursodeoxycholic Acid (UDCA) – High-Purity API for Hepatobiliary Therapy |
Ursodeoxycholic Acid (CAS 128-13-2), also known as UDCA or Ursodiol, is a clinically established bile acid widely used in liver and gallstone-related therapies. As a premium Ursodeoxycholic acid API, it is supplied in high-quality Ursodeoxycholic acid powder form for pharmaceutical formulation. With increasing global demand, it remains a key product among leading api manufacturers and pharmaceutical raw material suppliers.
Production & Manufacturing Process |
Our Ursodeoxycholic Acid is produced through a refined multi-step synthesis and purification process, ensuring consistent quality and scalability:
Raw Material Conversion: Derived from natural bile acid intermediates via controlled epimerization and hydroxylation reactions to obtain high-purity UDCA.
Purification Technology: Advanced crystallization and filtration processes ensure high purity Ursodeoxycholic acid ≥99% API supplier standards.
Process Optimization: Continuous improvement in reaction conditions enhances yield while minimizing impurities.
Industrial Scale Production: As a reliable Ursodeoxycholic acid bulk manufacturer GMP, we support both pilot and large-scale supply with stable output.
Applications & Therapeutic Value |
Liver Disease Treatment: Widely used in cholestatic liver diseases, improving bile flow and reducing liver enzyme levels.
Gallstone Dissolution: Effective in dissolving cholesterol gallstones and preventing recurrence.
Hepatoprotection: Protects liver cells from bile acid toxicity and oxidative stress.
Pharmaceutical Development: Essential API for global drug manufacturers seeking consistent Ursodeoxycholic acid price per kg competitiveness and supply stability.
Why Partner With Us? |
Trusted api manufacturers with strong production capacity
Competitive Ursodeoxycholic acid price per kg for bulk supply
Advanced synthesis technology ensuring purity and consistency
Reliable global logistics from experienced pharmaceutical raw material suppliers
Ursodeoxycholic Acid (UDCA) continues to be a cornerstone API in hepatology, combining proven efficacy with scalable manufacturing. As a professional Ursodeoxycholic acid DMF support supplier alternative, we focus on delivering high-quality raw materials and stable supply solutions for global pharmaceutical partners.
Contact us today for bulk pricing and production capacity details.
