TUDCA Powder | Tauroursodeoxycholic Acid CAS 14605‑22‑2, Synthetic Bile‑Acid Raw Material

TUDCA Powder Bulk Tauroursodeoxycholic Acid CAS 14605‑22‑2 | Hongda Phytochemistry

Many buyers for TUDCA powder bulk run into avoidable headaches even after receiving material that shows acceptable HPLC assay numbers on paper. Isomeric impurities, risk of hydrolytic breakdown during transit, inconsistent crystal particle behaviour and non‑matched batch documentation are recurring issues across the supply chain.

Find pharmaceutical-grade Tauroursodeoxycholic acid powder, a bile acid derivative that is at least 98% pure and works best for liver therapeutics, neuroprotective formulations, and metabolic uses. We make our bulk TUDCA in cGMP-certified places and give each batch its own Certificate of Analysis (CoA). Our Tauroursodeoxycholic acid powder meets strict pharmacopeial standards (USP/EP) and can be made in large amounts for use in clinical trials and for sale. To make sure that your drug development needs are met, either ask for a custom quote or download the technical dossier.

Bulk synthetic TUDCA (Tauroursodeoxycholic Acid) powder for lab synthesis and supplement raw‑material formulation. Batch‑matched HPLC, impurity profile and identity test reports. Lab‑size samples available.

Request quotation:duke@hongdaherb.com

Why Partner With Us for cGMP-Certified TUDCA?

• For quality control, each batch is tested for purity using HPLC, residual solvents, and heavy metals (≤10ppm).
• Set up for the rules: Pre-made DMF, CEP, and EDMF bundles make it easier to send things to the FDA and EMA.
• For injectables, you can choose the size of the particles (20–200µm), options that are free of endotoxins (<0.05 EU/mg), and sterile processing.
• Recycling bulk packaging and chemical-free manufacturing are green.

Product Parameters

What We Verify Before Every Shipment

Before releasing any TUDCA batch for overseas shipment, our in‑house lab completes these practical checks beyond simple HPLC assay： ‑ Check isomer‑related‑substance profile; trace levels of tauro‑chenodeoxycholic‑acid isomer are closely monitored. ‑ Confirm IR identity test result, to rule out mis‑labelled or blended raw‑material. ‑ Measure loss‑on‑drying, because elevated moisture will accelerate hydrolytic degradation of TUDCA molecule during long‑sea transit. ‑ Cross‑reference every physical batch against its own lot‑specific COA; we do not reuse generic template reports for different shipments. ‑ Inspect powder appearance for discoloration before drum sealing.

If you want to review real‑batch test excerpts before formal sample request, please contact us：duke@hongdaherb.com

TUDCA Benefits

1. Dissolve cholesterol stones: Tauroursodeoxycholic acid powder can gradually dissolve cholesterol, prevent cholesterol crystallization, and treat cholesterol.

2. Improve cholestasis: TUDCA bulk powder can increase bile flow and relieve symptoms such as jaundice and skin itching caused by cholestasis.

3. Protect liver cells: TUDCA supplements can reduce the damage of cholestasis to liver cells and protect liver function.

5. Auxiliary treatment of cholecystitis: TUDCA bulk powder plays an auxiliary role in the treatment of cholecystitis.

Formulation Support for Therapeutic Applications

1. Liver Protectants

Enhance bioavailability in oral tablets using our pH-stable TUDCA Powder Bulk, proven in NAFLD/NASH preclinical models.

2. Neuroprotective Injectables

Low-endotoxin grades (<0.05 EU/mg) compatible with IV infusion solutions for ALS and Alzheimer’s therapies.

3. Metabolic Syndrome Blends

Pre-mixed combinations with UDCA or FXR agonists available for diabetes/obesity drug pipelines.

Technical Guidance: Our pharmacologists optimize solubility profiles, excipient ratios, and dissolution rates. 

Quality Assurance Process 

‑ Lot‑matched COA with full HPLC‑related‑substances profile, IR identity result, loss‑on‑drying, heavy‑metal and microbiological data

‑ SDS safety‑data‑sheet for lab‑handling guidance

‑ Manufacturing‑route statement (synthetic‑process declaration)

‑ Supporting documents for fine‑chemical import customs clearance

Certification

We are certified in a number of areas, such as cGMP, FSSC22000, KOSHER, HALAL, BRC, ORGANIC, ISO9001, and ISO22000.

Prices for bulk and volume flexibility

• Minimum order quantity (MOQ) is 1 kg for pilot batches and 50 kg or more for business contracts.
• Discounts based on how much you order: Save up to 30% on orders of more than 500 kg per year.
• Custom packaging includes bags sealed with foil, drum containers, or vials flushed with nitrogen.

Sample Request: Test our TUDCA Powder in your formulation—Request a 50g Sample.

Packing, Shipment & Storage Practical Notes

Standard bulk packing：25 kg fibre drum, double light‑proof & moisture‑proof PE inner bag, hermetically sealed.

Recommended storage：Store sealed in cool, dry, dark warehouse. Minimise repeated drum opening to limit moisture ingress, which could trigger hydrolytic decomposition of TUDCA molecule.

Shipping reminder：For summer sea‑shipment to tropical high‑humidity destinations, we will adjust packing proposal accordingly. High container temperature together with moisture is the biggest risk factor for TUDCA bulk powder during ocean transit.

FAQs: TUDCA Powder Bulk

Q: Is your TUDCA suitable for injectable formulations?

A: Yes, our high-quality TUDCA Powder Bulk meets the USP <71> sterility and low-endotoxin standards for IV and IM use.

Q: Is it possible to change the purity or size of the particles?

A: Of course. We change the specifications (98–99.9% purity, 20–200µm particle size) to fit your formulation needs.
Q: What information do you give about stability?

A: Reports on stability at high temperatures (40°C/75% RH) and long-term (25°C/60% RH) according to ICH rules.

Q: How do you make sure that each batch is the same?

A: During synthesis, PAT (Process Analytical Technology) keeps an eye on important parameters in real time.

Q: Do you offer regulatory submission support?

A: Yes—DMF, ASMF, and CEP files are available for direct inclusion in your drug master files. 

Start Your Order

Share your target specification, end‑application and expected order volume through our inquiry form. Our team will reply with sample arrangement and bulk quotation：

📧 Contact Us: duke@hongdaherb.com

📞 Call: 13128890990

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