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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.
|
Parameter |
Specification |
|
Molecular Formula |
C₂₄H₄₀O₄ |
|
Appearance |
White crystalline powder |
|
Solubility |
Ethanol >100mg/ml; Insoluble in water |
|
Storage |
-20°C in vacuum-sealed bags |
|
Shelf Life |
36 months |
|
Heavy Metals |
<10ppm (ICH Q3D compliant) |
1. Pharmaceutical raw materials and Pharmaceutical chemicals
2. Health care material & Synergistic Formulations
|
Parameter |
Specification |
Compliance |
|
Purity |
≥99% (HPLC) |
USP/EP, ICH Q7 |
|
Heavy Metals |
<10 ppm |
ICH Q3D |
|
Endotoxins |
<0.1 EU/mg |
Injectable-grade |
|
Solubility |
Ethanol >100 mg/ml; Insoluble in water |
Optimized for encapsulation |
|
Shelf Life |
36 months at -20°C |
Accelerated stability tested |
XJESON’s UDCA powder enabled 30% faster dissolution in our enteric-coated tablets versus competitors.
– R&D Director, EU Top-10 Pharma
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).
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