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TUDCA Powder Bulk
2.Appearance: White Crystal Powder
3.Specification: 99%
4.CAS NO: 14605-22-2
5.Packing Specification: 25kg/drum, 27 drums/tray
6.Delivery: 3-7working days
7.Main Market: Europe, America, Vietnam, Indonesia, Southeast Asia, Thailand, Russia, etc.
8.Certification: cGMP,FSSC22000,KOSHER,HALAL,BRC,ORGANIC,ISO9001,ISO22000 etc.
- Product Description
High-Purity TUDCA Powder Bulk for Pharma Formulations
Find pharmaceutical-grade TUDCA Powder Bulk, 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). It 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.
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
Item of Test | Limits of Test | Results of Test | Method |
Appearance | White Powder | White Powder | Visual |
Odor | Characteristic | Characteristic | Visual |
Assay by HPLC | Tudca > 99% | 99.25% | USP<197K> |
Sulphated Ash | <0.1% | 0.05% | USP<467> |
Loss on drying | <1.0% | 0.26% | USP<467> |
Heavy Metals | <10ppm | Conforms | USP<231> |
As | <1. 0ppm | Conforms | USP<2232> |
Pb | <1. 0ppm | Conforms | USP<2232> |
Cd | <0. 05ppm | Conforms | USP<2232> |
Hg | Negative | Conforms | USP<2232> |
Total Plate Count | <1000cfu/g | 73cfu/g | GB4789.2 |
Yeast & Mold | <100cfu/g | 25cfu/g | GB4789.15 |
E. Coli | Negative | Absent | GB4789.38 |
S. Aureus | Negative | Absent | GB4789.2 |
Salmonella | Negative | Absent | GB4789.4 |
Pesticides | Negative | Absent | GB4789.10 |
Conclusion | Conform with specification | ||
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 Applications1. 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
1. Raw Material Testing: Sourced from audited suppliers
2. Multi-Step Purification: Patented crystallization technology
3. Final QC: HPLC, GC-MS, endotoxin/pyrogen screening
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 Bulk in your formulation—Request a 50g Sample.
Global Delivery with Compliance Assurance
- Shipping time is quick:In 5–7 days, it will arrive in North America, 7–10 days in the EU, and 10–14 days in APAC.
- Moving batches that are sensitive to heat at controlled temperatures is what cold chain logistics is all about.
- Customs paperwork includes pre-sent commercial invoices, SDS, and import permits.
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
Ready to source reliable TUDCA Powder Bulk?
📧 contact us: duke@hongdaherb.com
📞 Call: 13128890990
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