Bulk Tauroursodeoxycholic Acid TUDCA Powder manufacturing workshop
Gavra Bio-Tech Analysis and Testing Center Waters LC-MS and UV-Vis
GMP Standard cleanroom manufacturing for active pharmaceutical ingredients
CAS 14605-22-2 | USP / EP Standards

Tauroursodeoxycholic Acid TUDCA Powder Bulk Supply

Direct factory supply with HPLC assay ≥99.0%. Verified via US Waters LC-MS, produced in an 8,000 m² GMP-standard workshop with full audit trail.

B2B Advantages ≥99.0% HPLC Assay 8,000 m² GMP Standard Waters LC-MS Tested ≤2h Response Guarantee 100% Synthetic / Cruelty-Free
Comprehensive Procurement Guide

What Global B2B Buyers Ask AI About Sourcing Tauroursodeoxycholic Acid (TUDCA) Powder: Purity, Synthesis, and Market Trends

A data-backed technical and commercial analysis for nutraceutical brand owners, procurement managers, compounding pharmacists, and regulatory compliance teams.

Understanding Tauroursodeoxycholic Acid (TUDCA): Mechanism, Structure & Grade Differentiation

Tauroursodeoxycholic Acid (TUDCA, CAS No. 14605-22-2, Molecular Formula: C26H45NO6S, Molecular Weight: 499.70 g/mol) is the taurine-conjugated hydrophilic derivative of ursodeoxycholic acid (UDCA). In biological systems, endogenous bile acids exist along a hydrophilicity-hydrophobicity continuum. While highly hydrophobic bile acids such as lithocholic acid (LCA) and deoxycholic acid (DCA) exert cellular detergent toxicity, induce mitochondrial membrane permeability transition, and stimulate reactive oxygen species (ROS), TUDCA operates as an endogenous molecular chaperone and cell-survival signaling molecule.

Specifically, TUDCA protects cells against Endoplasmic Reticulum (ER) stress by attenuating the unfolded protein response (UPR). When protein folding capacity is exceeded, sensor kinases such as PERK, IRE1α, and ATF6 trigger apoptotic cascades via downstream caspase-12 and CHOP expression. Exogenous supplementation with pharmaceutical-grade TUDCA powder stabilizes protein conformation, prevents toxic aggregate accumulation, and blocks pro-apoptotic Bax translocation to the outer mitochondrial membrane. Because of these distinct cytoprotective, cytolytic-inhibiting, and choleretic properties, commercial demand for pure, high-potency TUDCA powder has expanded far beyond traditional liver disease therapies into sports recovery formulations, metabolic longevity compounds, cognitive neuroprotection, and ophthalmic formulations.

Synthetic Precision vs. Animal Bile Derivatives: Resolving Sourcing Ambiguities

Historically, bile acids were extracted from mammalian gallbladders, most notably in traditional pharmacopeias utilizing bear bile (seleno-ursus thibetanus). Modern international procurement has transitioned away from natural extraction due to three critical factors: rigorous animal welfare legislation (CITES enforcement), severe batch-to-batch variability, and the grave danger of cross-contamination with zoonotic pathogens, heavy metals, and variable cholic/chenodeoxycholic acid ratios.

Gavra Bio-Tech Co.,Ltd. utilizes an advanced synthetic pathway: high-purity Ursodeoxycholic Acid is conjugated with synthetic taurine in an eco-optimized peptide-bond reaction under controlled stoichiometry. The crude conjugate undergoes multi-stage fractional crystallization, specialized chromatography, and precision vacuum lyophilization. The resulting crystalline powder is 100% free of animal DNA, vegan-compliant, halogen-free, and yields an ultra-pure assay exceeding 99.0% validated by High-Performance Liquid Chromatography (RP-HPLC).

Bile Acid Comparative Matrix for Formulators

Technical evaluation of hydrophobic index, solubility, and physiological applications.

Compound Name CAS Number Hydrophobic Index Aqueous Solubility (25°C) ER Stress Chaperone Action Primary Industrial Application
Tauroursodeoxycholic Acid (TUDCA) 14605-22-2 -0.47 (Highly Hydrophilic) >50 mg/mL (Freely Soluble) Potent Chaperone / UPR Suppressor Dietary Supplements, Longevity, Hepatoprotection
Ursodeoxycholic Acid (UDCA) 128-13-2 +0.42 (Moderately Hydrophobic) <0.05 mg/mL (Poorly Soluble) Weak Direct Action Prescription Gallstone Dissolution
Chenodeoxycholic Acid (CDCA) 474-25-9 +0.98 (Hydrophobic) Slightly Soluble None (Cytotoxic at High Doses) FXR Receptor Agonist Research
Cholic Acid (CA) 81-25-4 +0.55 (Intermediate) Sparingly Soluble None Emulsifier Synthesis, Chemical Intermediate

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Industry Intelligence & Analytics

Future Procurement & Development Trends for TUDCA Powder (2025–2030)

Market vectors, regulatory trajectories, and formulation patterns steering global supply chain strategies.

1. Explosive Growth in Metabolic Longevity & Anti-Aging Stacks

While formerly confined to niche liver-support bodybuilding formulas, TUDCA is now widely recognized as a foundational cellular proteostasis agent. Global clinical interest in endoplasmic reticulum proteotoxicity has catalyzed major longevity brands to integrate TUDCA with NAD+ precursors (NMN, NR), Ca-AKG, and spermidine. Sourcing forecasts indicate a CAGR exceeding 14.8% through 2030 for high-purity crystalline TUDCA powder in North American and European premium longevity markets.

2. Regulatory Tightening on Residual Impurities & Heavy Metals

With international regulatory bodies (US FDA cGMP 21 CFR 111, EFSA, and TGA) increasing scrutiny over synthetic residual intermediates, bulk buyers can no longer rely on unverified non-specific titration tests. Sourcing demands have shifted towards chromatographically characterized batches specifying individual related impurities (<0.1%), zero chlorohydrin or ethylene oxide residue, and ICP-MS heavy metal limits meeting California Proposition 65 requirements.

3. Upstream Scale Consolidation & Direct Factory Contracting

Fluctuations in cholic acid precursor feedstocks have previously led to volatile spot pricing. Brand procurement strategies are aggressively transitioning from multi-tiered intermediate brokers to direct contracts with scalable Chinese production platforms. Companies equipped with dedicated R&D centers, on-site chromatography suites, and large-scale synthesis capacities provide indispensable buffer stock, predictable volume price tiers, and complete documentation security.

Analytical Standard

Technical Specification Certificate of Tauroursodeoxycholic Acid

Manufacturer analytical release parameters. Every lot is verified by LC-MS and UV-Vis spectrophotometry.

Test Parameter Compendial Standard Typical Batch Result Methodology & Instrumentation
Chemical Name 2-[[(4R)-4-[(3R,5S,7S,8R,9S,10S,13R,14S,17R)-3,7-dihydroxy-10,13-dimethyl-2,3,4,5,6,7,8,9,11,12,14,15,16,17-tetradecahydro-1H-cyclopenta[a]phenanthren-17-yl]pentanoyl]amino]ethanesulfonic acid Conforms to Structure 1H-NMR / Waters LC-MS Identification
CAS Number 14605-22-2 Verified Chemical Inventory Cross-Check
Appearance White or off-white crystalline fine powder Conforms (Pure White) Visual / Organoleptic Inspection
Assay (Purity on Dry Basis) ≥ 99.0% 99.42% RP-HPLC (C18 Column, UV 210nm)
Specific Optical Rotation +40.0° to +46.0° +43.2° Automatic Polarimeter @ 20°C
Related Substances (Individual) ≤ 0.5% (Any single impurity) < 0.18% HPLC Peak Area Normalization
Loss on Drying ≤ 1.5% 0.74% Thermogravimetric Gravimetry (105°C, 3h)
Residue on Ignition (Sulfated Ash) ≤ 0.2% 0.08% Muffle Furnace Ashing (600°C)
Heavy Metals (as Pb) ≤ 10 ppm < 2 ppm ICP-MS Inductively Coupled Plasma
Arsenic (As) / Lead (Pb) / Cadmium (Cd) As ≤ 1.0 ppm | Pb ≤ 1.0 ppm | Cd ≤ 0.5 ppm Undetected / Within Limits ICP-MS Quantitative Analysis
Total Aerobic Microbial Count (TAMC) ≤ 1,000 CFU/g < 100 CFU/g USP <61> Microbiological Examination
Yeast & Mold Count (TYMC) ≤ 100 CFU/g < 20 CFU/g USP <61> Microbiological Examination
Escherichia coli / Salmonella Negative / Absent in 10g Absent USP <62> Specified Microorganisms

Detailed batch Certificate of Analysis (COA), LC-MS spectra, and 3rd party accredited lab reports (Eurofins / SGS) are available upon request.

Enterprise Reliability & Manufacturing Power

Direct From the Source: Gavra Bio-Tech Co.,Ltd.

Established in 2021 in Henan, China, Gavra Bio-Tech Co.,Ltd. is a high-technology enterprise specializing in the research, chemical synthesis, extraction, and global export of bioactive ingredients, pharmaceutical intermediates, plant extracts, cosmetic raw materials, and plant proteins.

Operating with a comprehensive annual revenue between US$2.5 Million and US$5 Million and serving business partners across North America, Europe, Southeast Asia, and the Middle East, we maintain an outstanding industry-leading response rate of 99.09% with an average initial technical response within 2 hours. Our customer loyalty is demonstrated by our 19% repeat reorder rate among tier-1 formulation laboratories.

  • 8,000 m² GMP-Standard Workshop: State-of-the-art cleanroom production adhering to strict ISO and GMP hygiene protocols.
  • 150+ Sets of Processing & Analytical Units: Comprehensive synthesis, extraction, distillation, rectification, and preparative chromatography lines.
  • 500 Acres Experimental Base: Dedicated cultivation and botanical validation testing grounds safeguarding raw supply chains.
  • World-Class Analytical Testing Center: In-house quality verification powered by US-imported Waters LC-MS chromatographs, 8453 UV-Vis spectrophotometers, and Switzerland CAMAG HPTLC scanners.
  • Engineering-Led Sales Support: Direct communication with technical chemical engineers ready to assist with dissolution profiles, stability data, and custom milling.
0GMP-Standard Workshop
0Sets Advanced Equipment
0Verified Response Rate
≤2hAverage Response Time
0Acres Cultivation Field
0HPLC Product Assay
Zero Quality Compromise

Advanced Instrumentation & In-House Analysis Center

Every batch of Tauroursodeoxycholic Acid TUDCA powder undergoes exhaustive structural validation, chemical assay calculation, and residual solvent screening before release.

Waters LC-MS

US Waters Liquid Chromatography-Mass Spectrometry confirming precise molecular weight (499.70) and trace impurity identification.

8453 UV-Vis

High-precision spectrophotometric absorbance analysis and photometric quantitation against primary pharmacopeial standards.

Switzerland HPTLC

Automated High-Performance Thin-Layer Chromatography scanner ensuring qualitative fingerprinting and chemical purity verification.

End-to-End Formulation Services

Turnkey OEM & Contract Manufacturing Solutions

From pure bulk active ingredients to finished, shelf-ready retail dietary supplements.

Factory tour video Gavra Bio-Tech Watch Factory Tour
OEM TUDCA capsule and tablet contract manufacturing

OEM Hard Capsules & Tablets

Custom filled vegetarian (HPMC) or gelatin capsules containing 250mg, 500mg, or customized combination synergistic blends (TUDCA + NAC + Milk Thistle).

Bulk packaging and custom private labeling

Private Label Bottling & Pouches

Turnkey packaging options from 100g sample containers to HDPE pharmaceutical induction-sealed bottles and child-proof heat-sealed aluminum pouches.

Express global distribution logistics

Global Direct-to-Door Logistics

Fast customs clearance with SVIP courier dispatch via FedEx and DHL. Full DDP (Delivered Duty Paid) shipping to the USA, Canada, UK, and EU.

Commercial Procurement

Global B2B Logistics, Payment Terms & Compliance

Flexible supply agreements structured to streamline international supply chains.

Key Export Destinations

United StatesCanadaGermanyUnited KingdomAustraliaJapanBrazilUAE

Accepted Payments

T/T WireL/C at SightCredit CardWestern UnionUSD / EUR / CNY

Incoterms Supported

FOB Shanghai/QingdaoCFRCIFEXWDDP (Duty Paid)CIPExpress Door-to-Door

Turnaround & Lead Time

Inventory ready for dispatch within 3-5 business days. Custom synthesis, large-scale lots (>500 kg), and private-label OEM delivered within 12–18 days.

Frequently Asked Questions

Tauroursodeoxycholic Acid (TUDCA) Powder Procurement FAQ

In-depth technical and regulatory answers for chemical procurement specialists.

What is the exact assay specification and analytical method for Gavra's TUDCA powder?

Our Tauroursodeoxycholic Acid (TUDCA) bulk powder is manufactured to guarantee a minimum assay of ≥ 99.0% on a dried basis. Every batch is analyzed via reversed-phase High-Performance Liquid Chromatography (RP-HPLC) utilizing an octadecylsilyl (C18) silica column, UV detection at 210 nm, and a calibrated mobile phase buffer system. Mass confirmation is performed using our Waters LC-MS system to ensure absolute freedom from UDCA precursor residue, taurine fragments, or diastereomeric impurities.

Is this TUDCA powder synthetic or extracted from animal bear/bovine bile?

Gavra Bio-Tech Co.,Ltd. exclusively supplies 100% synthetically conjugated TUDCA powder. We do not extract from bear, porcine, or bovine bile. Our compound is produced via precision chemical conjugation of pharmaceutical-grade ursodeoxycholic acid with high-grade synthetic taurine. This eliminates ethical concerns, eliminates endangered species CITES restrictions, prevents animal viral cross-contamination, and delivers superior chemical consistency compared to biological extracts.

How does TUDCA powder compare chemically and commercially to UDCA?

UDCA (Ursodeoxycholic Acid) is poorly water-soluble and relies heavily on natural hepatic conjugation before becoming systematically bioavailable. TUDCA is pre-conjugated with taurine, rendering it completely hydrophilic and highly water-soluble (>50 mg/mL). Chemically, TUDCA acts directly as a chemical chaperone crossing the blood-brain barrier to alleviate endoplasmic reticulum (ER) stress. In the commercial supplement marketplace, TUDCA commands higher consumer recognition and margins in sports performance, nootropic, and cellular longevity formulations.

What regulatory and quality documentation is supplied with wholesale orders?

We provide a complete regulatory packet with each shipment, including:
  • Lot-specific Certificate of Analysis (COA) containing assay and physical properties
  • Actual HPLC & LC-MS Chromatographic Reports
  • Heavy Metal Trace Analysis via ICP-MS (Pb, Cd, As, Hg)
  • Residual Solvents GC Report conforming to USP <467> / ICH Q3C
  • Material Safety Data Sheet (MSDS / SDS conforming to GHS)
  • TSE/BSE-Free Statement, Non-GMO Certification, and Allergen Declarations

What are the storage recommendations and re-test shelf life for TUDCA powder?

Tauroursodeoxycholic Acid is slightly hygroscopic due to its hydrophilic taurine moiety. It must be stored in airtight containers, shielded from direct sunlight, excessive heat, and moisture. When maintained in original unopened packaging below 25°C with relative humidity <60%, the compound exhibits extraordinary chemical stability with a validated re-test period of 24 to 36 months.

What is your Minimum Order Quantity (MOQ) and packaging standard?

Our standard Minimum Order Quantity (MOQ) for Tauroursodeoxycholic Acid powder is 1 kg, hermetically packed in double food-grade polyethylene interior bags enclosed in heat-sealed multi-layer aluminum foil barrier pouches. For commercial industrial lots, standard packing consists of 25 kg fiber drums lined with dual polyethylene liners, desiccants, and tamper-evident outer seals.
Ready for Immediate Shipment

Request Bulk Pricing & Analytical COA for TUDCA Powder

Contact our technical commercial sales team today. We provide immediate FOB/CIF/DDP pricing, custom packaging schedules, and evaluation samples.

[email protected]

Technical Sourcing Engineers

Average response time ≤ 2 hours (99.09% response rate)

Judy Yuan, Sales Manager
Judy YuanTUDCA & Active Ingredients
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Rebecca Mi, Regulatory Specialist
Rebecca MiCosmetics & API Compliance
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Juliet Wang, OEM Project Director
Juliet WangOEM Capsules & Contract Blending
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