What is Ursodeoxycholic Acid Powder?

Ursodeoxycholic Acid (UDCA) is a hydrophilic, dihydroxy bile acid naturally found in human bile, synthesized as a white crystalline powder (molecular formula: C₂₄H₄₀O₄). It modulates bile composition by reducing cholesterol saturation and enhancing hepatobiliary detoxification17. XJESON’s pharmaceutical-grade UDCA powder (CAS 128-13-2) is produced via patented catalytic hydrogenation, achieving ≥99% HPLC-verified purity with ultra-low endotoxins (<0.1 EU/mg), suitable for injectables and oral formulations.

Technical Specifications

 Key Benefits & Applications

 1. Pharmaceutical raw materials and Pharmaceutical chemicals

• PBC (Primary Biliary Cholangitis) Treatment
• Mechanism: Replaces toxic bile acids, inhibits apoptosis of hepatocytes, and reduces inflammatory markers.
• Dosage: 10–15 mg/kg/day in tablets/capsules; improves survival rates in early-stage PBC.
• Cholesterol Gallstone Dissolution
• Efficacy: Dissolves X-ray translucent stones (<5 mm diameter) with 70% success rate at 10 mg/kg/day.
• Patient Selection: Requires a functional gallbladder and non-calcified stones.
• NAFLD/NASH Therapy
• Emerging Use: Reduces liver fibrosis and steatosis in Phase III trials (30 mg/kg/day).

 2. Health care material & Synergistic Formulations

• Liver Health Supplements: Combined with silymarin (milk thistle) or artichoke extract to enhance bile flow and reduce biliary sludge (32.4% dissolution rate in clinical studies).
• Metabolic Health: Lowers serum cholesterol and improves lipid profiles in metabolic syndrome models.

 Technical Specifications (XJESON UDCA Powder)

XJESON Quality Assurance

• Traceability: Batch-specific COA with HPLC/MS, NMR, and residual solvent reports47.
• Stability Studies: 24-month accelerated testing confirms potency retention >98%9.
• Scalability: MOQs from 1kg (R&D) to 10MT (commercial); lead time 14 days15.

Why Partner with XJESON?

XJESON’s UDCA powder enabled 30% faster dissolution in our enteric-coated tablets versus competitors.
– R&D Director, EU Top-10 Pharma

1. End-to-End Compliance: Full documentation for FDA/EMA audits.
2. Technical Support: Free formulation consulting + preclinical data packages.
3. Supply Resilience: Dual sourcing from ISO 13485-certified plants (China + EU).

 FAQs for B2B Clients

Q1: What purity standards does XJESON UDCA powder meet?

A: All batches comply with FDA/EMA/WHO-GMP guidelines. Purity ≥99% verified by HPLC/MS, with residual solvent limits per ICH Q3C.

Q2: Can UDCA powder be used in NAFLD nutraceuticals?

A: Yes. It is clinically validated for NAFLD support at 250–500 mg/day doses, often combined with artichoke or green tea extracts for synergistic hepatoprotection.

Q3: How does synthetic UDCA compare to animal-derived sources?

A: XJESON’s synthetic process eliminates pathogen risks (e.g., from bear bile) and ensures batch consistency. Cost is 20% lower than bio-extracted UDCA.

Q4: Is UDCA effective for bile reflux gastritis?

A: Yes. It displaces toxic bile acids in the stomach, reducing mucosal injury at 300 mg/day doses.

Q5: What documentation supports regulatory submissions?

A: Full DMF, COA (HPLC/NMR), and 24-month stability data provided. REACH/ISO 13485 certifications available for EU/NA markets.

Q6: How to store bulk UDCA powder for long-term stability?

A: Store at -20°C in vacuum-sealed bags with oxygen absorbers. Avoid moisture and light exposure.

Q7: Can you customize particle size for tablet formulation?

A: Yes. Options: 50–200 μm (direct compression) or micronized (<50 μm for enhanced bioavailability).