UDCA Powder

High-Purity UDCA Powder for Use in Pharmaceuticals and Research

Shaanxi Hongda Phytochemistry produces high-quality ursodeoxycholic acid UDCA powder that meets cGMP certification standards and is manufactured in a rigorously inspected production facility that complies with USP/EP/JP standards. As a professional manufacturer of active pharmaceutical ingredients (APIs), we offer ursodeoxycholic acid powder using a modern two-step enzymatic catalysis and green chemical conversion integrated process. We provide regular powder, micronized powder (e.g., D90 < 10µm, specifically for immediate-release tablets or suspensions with high dissolution requirements), and granules (to improve the flowability of direct compression). It is highly suitable for treating liver diseases, breaking down gallstones, and controlling cholestasis, and is widely used in liver disease treatment.

Get samples or bulk quotes now:duke@hongdaherb.com.

What Is UDCA Powder?

Ursodeoxycholic acid (UDCA, CAS: 128-13-2) is a core hydrophilic bile acid raw material used globally for the clinical treatment of primary biliary cholangitis (PBC), dissolving cholesterol gallstones, and alleviating non-alcoholic fatty liver disease (NAFLD). Its bioavailability and formulation stability in the final product depend entirely on the purity of the active pharmaceutical ingredient (API) and the control level of trace toxic impurities. As a professional manufacturer deeply rooted in the global pharmaceutical and health product raw material supply chain, Shaanxi Hongda supplies pharmaceutical-grade and high-purity supply chain-grade UDCA bulk powder. This not only provides excellent in vitro dissolution performance but also mitigates potential risks related to compliance audits and adverse reactions in final products for global pharmaceutical companies and multinational purchasers from the source.

Why Should You Choose Our Ursodeoxycholic Acid Powder?

Assay Content: 99.0% ~ 101.0% (Titration), reducing dosage deviations in final formulations and ensuring uniform efficacy.

Micronization Technology: Utilizing micronization technology, it is absorbed by the body faster than ordinary capsules, allowing for better efficacy with each dose and more effective treatment of diseases.

Impurity A (Chenodeoxycholic Acid): ≤ 1.0% (HPLC), strictly controlling the toxicity of hydrophobic bile acids and reducing gastrointestinal side effects.

Total Impurities: ≤ 1.5% (HPLC), significantly improving the chemical stability of the finished drug formulation over its shelf life.

Thorough Quality Control
- Third-Party Tested: Independent lab verification for each batch
- cGMP Certified: Exceeds international standards
- Non-GMO & Gluten-Free: Pure ingredients without fillers

Product Parameters

UDCA Powder Production Process:

1. Raw Material Input: High-purity plant-based steroidal compounds or specific bile acid precursors without animal-derived risks are selected as starting materials.

2. Enzymatic Conversion: Targeted hydroxyl isomerization conversion is carried out using highly specific engineered enzymes in a mild, temperature-controlled aqueous system.

3. Purification and Recrystallization: Multi-stage fractional crystallization is performed using non-toxic, environmentally friendly organic solvents that meet pharmaceutical standards to thoroughly remove high-risk impurities.

4. Crystallization and Micronization: The material is processed into a stable crystalline powder with a specific particle size distribution (PSD) through precision airflow milling and temperature-controlled drying technology.

5. Refined Packaging: Fully automated double-layer polyethylene bag sealing is performed in a clean area meeting Grade D (or higher) standards, and the bags are then filtered through an online strong magnetic trap to ensure the absence of metallic foreign objects.

Core Benefits

1. Hepatobiliary Protection

• UDCA bulk powder can promote bile secretion, improve cholestasis, treat primary biliary cirrhosis, cholangitis and other diseases.
• Regulate liver lipid metabolism, reduce fatty liver (NAFLD) and drug-induced liver injury.

2. Metabolic Regulation

• UDCA Powder can reduce bile cholesterol saturation and dissolve cholesterol gallstones.
• Assist in improving sugar and lipid metabolism disorders (supported by animal studies).

3. Anti-inflammatory Effects

• Relieve bile duct inflammation (such as chronic cholecystitis) and relieve bile reflux gastritis.
• Targeted colon delivery technology (sulfate derivatives) can relieve intestinal inflammation.

Main applications

Bile duct and liver diseases

• Treatments for PBC/PSC and intrahepatic cholestasis during pregnancy are first-line.
• Combination therapy: improves liver fibrosis treatment with traditional Chinese medicine like Dahuang Lidan Capsule.

Diseases of the digestive system

• Dissolve cholesterol gallstones (this needs long-term medication).
• Treating chronic cholangitis and bile reflux gastritis.

Managing metabolism

• Adjuvant treatment for non-alcoholic fatty liver disease (NAFLD).
• Possible effects on lowering lipids and blood sugar (needs more clinical proof).

How We Ensure Unmatched Quality

1. Screening of raw materials: These come from suppliers who have been checked and tested for identity (FTIR/NMR).

2. Synthesis and purification: Our patented crystallization technology gets rid of impurities (less than 0.1%).

3. Stability Testing: 6-month accelerated ICH studies validate storage conditions.

4. Traceability: Lot-specific documentation from production to delivery.

Comprehensive Regulatory and Documentation Support

Shaanxi Hongda can provide comprehensive technical support materials tailored to your target market, including complete batch production records (BPR), three batch stability study reports (long-term/accelerated), residual solvent and elemental impurity (ICH Q3D) analysis reports compliant with ICH guidelines, and comprehensive certifications (such as KOSHER, HALAL, ISO9001, ISO22000, etc.).

Tailored for Your Needs

Pharmaceutical Manufacturers

• Bulk Sizes: 25kg drums to metric ton quantities
• Custom Formats: Micronized particles, sterile lyophilized powder
• Regulatory Support: DMF/CEP files available

Research Institutions

• Small Batches: 1g to 10kg, with choices for RUO and GMP grades
• Formats that are specific: Isotope-labeled (like 13C-UDCA) for studies that use tracers
• Quick Delivery: Cold-chain shipping to labs in 72 hours

Reliable Logistics

• Standard Packaging: Our packaging consists of 25 kg/cardboard medical drums, with an inner double-layered, high-density, pharmaceutical-grade moisture-proof polyethylene (PE) sealed bag. For pilot and pilot-scale testing, 1 kg and 5 kg aluminum foil bags are available for sample packaging.
• Global Shipping: Store in a cool, dry place (not exceeding 20°C), protected from light and sealed. For bulk shipments, use pallets and fully enclosed wrapping film for curing to prevent damage from bumps and moisture in the container during cross-border shipping.

FAQ

Q: How does UDCA differ from TUDCA?
A: UDCA powder is the primary bile acid that TUDCA converts into. Direct supplementation provides faster bioavailability.

Q: Can this help with primary biliary cholangitis?
A: Studies show daily UDCA Pure Powder significantly slows PBC progression. Dose adjustments under medical supervision are recommended.

Q: Is third-party testing available?
A: Yes! Scan the QR code on your package for full lab reports.

Q: Safe for long-term use?
A: Clinical trials support safety for 24+ months. We advise quarterly liver function tests.

Get Expert Support

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Contact our API specialists at duke@hongdaherb.com for:

✅ Bulk pricing within 2hrs

✅ Free 100g research samples

✅ Stability/toxicity datasets

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