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PURECIUM — Premium B2B Supplement Ingredients Supplier
PURECIUM — Premium B2B Supplement Ingredients Supplier

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PURECIUM — Premium B2B Supplement Ingredients Supplier
PURECIUM — Premium B2B Supplement Ingredients Supplier

PURECIUM

  • HOME
  • PURECIUM
  • INGREDIENTS
  • NEWS
  • CUSTOMIZED
  • QUALITY CONTROL
  • CONTACT
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    • PURECIUM
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PURECIUM — Premium B2B Supplement Ingredients Supplier
  • TUDCA Powder for Liver, Bile and Metabolic-Wellness Supplement Formulations

    TUDCA Synthesized to 98% HPLC Purity in ISO 9001 and FSSC 22000 Certified Facilities

    Embodies the essence of pure, high-quality dietary supplement ingredients

  • TUDCA (Tauroursodeoxycholic Acid) Powder

    Liver-Support Hydrophilic Bile Acid

    TUDCA powder, fssc22000 certificated

    TUDCA

    Purecium TUDCA is tauroursodeoxycholic acid, the taurine conjugate of ursodeoxycholic acid, supplied as a B2B raw material for liver-support and metabolic-wellness supplements. It carries CAS 14605-22-2, molecular formula C26H45NO6S and molecular weight 499.70 g/mol, and is offered at 98% minimum purity by HPLC as a white crystalline powder. Produced by controlled semisynthesis from ursodeoxycholic acid and taurine, it is not sourced from animal bile. Packed in 25 kg drums with a 25 kg minimum order and full documentation including COA and SDS, it is stocked at Purecium's US warehouse for fast B2B delivery.

    Product name: TUDCA (Tauroursodeoxycholic Acid)

    Molecular formula: C26H45NO6S

    Starting material: Ursodeoxycholic acid (UDCA) + taurine (semisynthesis)

    Grade: Nutritional grade; USP/EP-conformity available

    Heavy Metals: Conforms to USP/EP limits

    Pesticide residue: Conforms to USP/EP limits

    Packing size: 25kg/drum

    CAS#: 14605-22-2

    Molecular weight: 499.70 g/mol

    Source: Semisynthetic (UDCA-taurine conjugation)

    Specification: Tauroursodeoxycholic acid >=98% (HPLC); 99% available

    Country of origin: China

    Residual solvent: Conforms to USP/EP limits

    Allergen free/Gluten-free/Non-GMO/Vegan/Non-Irradiation:

    TUDCA ISO, Kosher, halal, food safety certification

    TUDCA Overview

    TUDCA, or tauroursodeoxycholic acid, is a hydrophilic bile acid formed by the conjugation of taurine with ursodeoxycholic acid (UDCA). It occurs endogenously in humans at low concentrations as part of the bile-acid pool, and it is the best-known bile-acid ingredient in the dietary-supplement category, where it is used for liver-support and metabolic-wellness formulas. The molecule carries CAS 14605-22-2, molecular formula C26H45NO6S and molecular weight 499.70 g/mol.

    Historically, TUDCA was identified as a major bile acid of bear bile and has a long record of traditional use in Asia; modern commercial supply is produced by semisynthesis and is never sourced from bears. Purecium supplies TUDCA as a B2B raw material for distributors, contract manufacturers, private-label producers and finished supplement brands, at a minimum purity of 98% by HPLC.

    Source & Ingredient Identity

    Purecium TUDCA is manufactured by controlled semisynthesis: ursodeoxycholic acid (UDCA, CAS 128-13-2, C24H40O4) is conjugated with taurine through an amide bond at the bile-acid side chain to form tauroursodeoxycholic acid. UDCA itself is an industrial bile acid produced from bile-acid chemistry or biotransformation routes, and the conjugation is followed by crystallization, drying and purification to a white crystalline powder of at least 98% purity by HPLC.

    The declared product is tauroursodeoxycholic acid, also known as ursodeoxycholyltaurine, taurursodiol or ursodoxicoltaurine. Because the free acid form is only sparingly soluble in water while the sodium salt form dissolves readily, buyers should specify the form on the specification sheet; Purecium supplies the crystalline acid form as standard and the water-soluble sodium salt form on request.

    Key Characteristics of TUDCA

    1. Hydrophilic, cytoprotective bile acid. TUDCA is more hydrophilic than most endogenous bile acids, a property that reduces the membrane-damaging potential associated with hydrophobic bile acids and underlies its use in liver-support products. Peer-reviewed research describes cytoprotective effects in liver cells, including reduced endoplasmic-reticulum stress and stabilization of mitochondrial function, though finished-product communication should follow structure/function language.

    2. Defined analytical identity. The molecule is a taurine conjugate of UDCA with CAS 14605-22-2, formula C26H45NO6S and molecular weight 499.70 g/mol, melting near 173-175 degrees Celsius. Commercial quality is specified by HPLC assay (minimum 98%), related bile-acid impurities, specific optical rotation, residual solvents and heavy metals, with USP/EP-conformity options available for buyers requiring pharmacopoeia-aligned material.

    3. Clean, stable and formulation-friendly profile. TUDCA is a white to off-white crystalline powder with a stable, non-hygroscopic profile under normal storage, and it is non-GMO, allergen-free and gluten-free. Because bile acids carry a bitter taste, finished formats are typically capsules or coated tablets, and the crystalline grade compresses cleanly with standard excipients.

    TUDCA Manufacturing

    The production route starts from ursodeoxycholic acid, which is activated and coupled with taurine to form the amide conjugate, followed by neutralization, crystallization, filtration, washing and drying under controlled conditions. Each stage is monitored with in-process checks on reaction completeness, pH, solvent recovery and purity, and the process is designed to keep related bile-acid impurities within specification while delivering a consistent crystalline product.

    Finished lots are tested by validated HPLC for assay and related substances, with additional testing for identification, specific optical rotation, loss on drying, residual solvents by GC, heavy metals and microbial limits. Analytical methods follow the current European Pharmacopoeia and USP-NF approaches for bile-acid analysis where applicable, and all results are reported on the batch Certificate of Analysis.

    Applications of TUDCA

    Liver-support formulas are the primary application. As a hydrophilic bile acid, TUDCA is used in dietary supplements positioned for healthy liver function, bile flow and detoxification support, and it is frequently combined with liver-herb extracts such as milk thistle silymarin, N-acetylcysteine and artichoke. Peer-reviewed preclinical research describes cytoprotective, anti-apoptotic and endoplasmic-reticulum-stress-modulating actions in hepatocytes, and these mechanisms are the scientific basis of the ingredient's liver-support positioning.

    Metabolic and cellular-health supplements form the second cluster. Research interest in TUDCA extends to metabolic signaling, mitochondrial health and cellular stress responses, and it appears in premium longevity and metabolic-wellness blends alongside NAD+ precursors and other specialty ingredients. Commercial finished products commonly provide 250 to 500 mg of TUDCA per serving in capsule form.

    Formulators should note that TUDCA is used in the United States within the FDA structure/function framework without disease claims, and that in the European Union no health claim has been authorized for TUDCA or bile acids to date; finished-product wording must follow the food-information rules of each destination market. The free-acid form suits capsule filling, while the sodium salt form is preferred where water solubility is required.

    Manufacturing & Quality Control

    Purecium TUDCA is produced in facilities operating under ISO 9001 and FSSC 22000 certified quality systems, with Kosher and Halal certification available. Every lot is tested for identity, HPLC assay of at least 98%, related bile-acid impurities, specific optical rotation, residual solvents, heavy metals and microbiology, and the material can be aligned with USP or EP bile-acid monograph approaches on request.

    Each commercial lot is traceable from starting materials to finished drum, and the Certificate of Analysis documents purity, impurities and physical data for every batch. Purecium also provides the specification sheet, SDS, allergen and gluten statements, non-GMO declarations and stability data, supporting customer registration and quality files in regulated markets.

    TUDCA for B2B Supplement Manufacturing

    Purecium supplies TUDCA exclusively as a B2B raw material for distributors, contract manufacturers, private-label producers and finished supplement brands. The minimum order quantity is 25 kg; the product is packed in 25 kg drums with food-grade polyethylene inner bags, and samples and full documentation are available before commitment.

    For North American customers, inventory is staged at Purecium's US warehouse, enabling pickup or delivery within approximately two days. Global delivery covers Hong Kong, mainland China, the EU and other regions, with export documentation prepared for every shipment, and Purecium provides technical and regulatory communication to support formulation and registration in each destination market.

    Reviewed by the Chief Quality Assurance / Regulatory Affairs Specialist at Purecium for technical accuracy and regulatory alignment.

  • TUDCA workshop
    TUDCA packing room
    TUDCA testing
    TUDCA production
    TUDCA factory
    TUDCA workshop
    TUDCA workshop
    TUDCA production
    TUDCA packing room
    TUDCA testing
    TUDCA factory
    TUDCA workshop
  • TUDCA Frequently Asked Questions (FAQ) for B2B Buyers

    Q1. What exactly is TUDCA and how does it differ from UDCA?

    TUDCA is tauroursodeoxycholic acid, the bile acid formed when taurine is conjugated to ursodeoxycholic acid (UDCA) through an amide bond. UDCA carries CAS 128-13-2 and formula C24H40O4, while the taurine conjugate TUDCA carries CAS 14605-22-2, formula C26H45NO6S and molecular weight 499.70 g/mol. Conjugation with taurine makes the molecule more hydrophilic, which changes its behavior in the bile-acid pool and is the basis of its distinct positioning in liver-support products.

    Q2. What purity and specification of TUDCA does Purecium supply?

    Purecium supplies TUDCA at a minimum purity of 98% by HPLC, with 99% HPLC available on request, as a white crystalline powder. Each lot is tested for identity, related bile-acid impurities, specific optical rotation, loss on drying, residual solvents, heavy metals and microbiology, and results are reported on the batch Certificate of Analysis. Material aligned with USP or EP bile-acid monograph approaches can be supplied for buyers who require it.

    Q3. How is commercial TUDCA produced, and is it sourced from bear bile?

    Commercial TUDCA is produced by semisynthesis: ursodeoxycholic acid is conjugated with taurine, then purified by crystallization to a white powder of at least 98% purity. Modern commercial supply is never sourced from bears. Historically, bear bile was the traditional source that made TUDCA famous in Asian medicine, but ethical, conservation and quality considerations have made semisynthetic production the only standard used by reputable ingredient manufacturers.

    Q4. Is TUDCA vegan, and what is its starting material?

    TUDCA is a bile-acid derivative, and its starting material ursodeoxycholic acid is commonly manufactured from bile-acid chemistry or biotransformation routes. Standard commercial TUDCA is therefore declared as not vegan-certified, although batches based on non-animal-sourced UDCA can be supplied on request for buyers with strict vegan requirements. The product is allergen-free, gluten-free and non-GMO, and we recommend confirming the starting-material statement with your supplier.

    Q5. Why is TUDCA described as a hydrophilic bile acid, and why does that matter?

    Bile acids differ in polarity. Hydrophobic bile acids can intercalate into cell membranes and cause damage when they accumulate, while hydrophilic bile acids such as TUDCA are better tolerated by membranes and are associated with cytoprotective effects in the liver. TUDCA's high hydrophilicity, a direct consequence of its taurine conjugation, is the physicochemical reason it is used in liver-support supplements rather than more hydrophobic bile-acid forms.

    Q6. What mechanisms of action are described for TUDCA in scientific research?

    Peer-reviewed research describes TUDCA as a chemical chaperone that reduces endoplasmic-reticulum stress, stabilizes mitochondrial function, inhibits apoptosis pathways and modulates inflammatory signaling in liver and other cells. These mechanisms are studied mainly in preclinical models and are relevant to its liver-support and cellular-health positioning. Finished-product communication should use structure/function language and must not claim to diagnose, treat or cure disease.

    Q7. What is the difference between TUDCA free acid and the sodium salt form?

    TUDCA free acid (CAS 14605-22-2) is only sparingly soluble in water and is the standard crystalline form for capsule filling. The sodium salt of tauroursodeoxycholic acid is freely water-soluble and is used where aqueous solubility is needed, such as liquid or research applications. Specify the form, the CAS number and the assay on the specification sheet so that the delivered material matches your formulation.

    Q8. What typical doses of TUDCA are used in finished supplements?

    Commercial TUDCA supplements commonly provide 250 to 500 mg per serving in capsule form, typically taken once or twice daily as directed on the label. Because TUDCA is not an essential nutrient with established dietary reference values, finished-product levels and dosing should be set by the brand on the basis of the intended positioning and destination-market rules. Purecium supplies specification and application guidance for formulation.

    Q9. Is TUDCA approved as a dietary supplement ingredient with health claims?

    In the United States, TUDCA is marketed as a dietary-supplement ingredient within the FDA structure/function framework, which permits statements about supporting healthy liver function but prohibits disease claims. In the European Union, no health claim has been authorized for TUDCA or bile acids to date, and finished products must use general food-information statements. Confirm the claim framework of each destination market before finalizing labels.

    Q10. Which ingredients are commonly combined with TUDCA in liver-support formulas?

    TUDCA is frequently formulated with milk thistle extract (silymarin), N-acetylcysteine, artichoke extract and other liver-oriented botanicals, as well as with taurine itself, which is the conjugating amino acid. For metabolic-wellness positioning it is also paired with specialty ingredients in premium longevity blends. Compatibility, stability and finished-product testing for your specific formula are recommended before scale-up.

    Q11. How is TUDCA quality verified by HPLC, and what impurities are controlled?

    TUDCA assay is determined by validated reverse-phase HPLC with UV detection, quantifying the main peak against a reference standard. Related-substance testing controls other bile acids and synthetic intermediates, typically keeping any single impurity below 0.1% to 0.5% depending on the specification, and residual solvents are checked by gas chromatography. Ask for the HPLC chromatogram and impurity table on the batch Certificate of Analysis.

    Q12. How should TUDCA powder be stored, and what is its shelf life?

    Store TUDCA in tightly sealed original containers in a cool, dry place below 25 degrees Celsius, protected from light and moisture. The crystalline material is stable under these conditions, with a typical shelf life of 24 to 36 months from manufacture. Because bile acids are sensitive to strong oxidizers and prolonged heat, avoid excessive temperature during blending and keep the container sealed after sampling.

    Q13. What quality documentation should we request when sourcing TUDCA?

    Request a current specification sheet and a batch-specific Certificate of Analysis showing HPLC assay, related-substance profile, specific optical rotation, residual solvents, heavy metals and microbial results, plus an SDS and allergen and gluten statements. Also request ISO 9001 and FSSC 22000 certificates, Kosher and Halal certificates where relevant, the starting-material statement and stability data for registration files.

    Q14. What is the MOQ, packing and lead time for TUDCA from Purecium?

    The minimum order quantity is 25 kg, and the product is packed in 25 kg drums with food-grade polyethylene inner bags. Samples and full technical documentation are available before commitment. Standard production lead time is typically 7 to 15 working days after order confirmation, with faster dispatch for stocked lots. For North American customers, inventory is staged at Purecium's US warehouse for pickup or delivery within about two days.

    Q15. Why should we source TUDCA from Purecium?

    Purecium supplies TUDCA at 98% minimum HPLC purity from controlled semisynthesis, with every batch released on a full Certificate of Analysis covering assay, related bile-acid impurities, optical rotation, residual solvents, heavy metals and microbiology. Production follows ISO 9001 and FSSC 22000 certified systems with Kosher and Halal certification available, the minimum order is 25 kg, US warehouse inventory enables fast fulfillment, and global delivery covers Hong Kong, mainland China, the EU and beyond.

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    PURECIUM LIMITED|B2B Vitamin & Nutraceutical Ingredients Supplier
    PURECIUM LIMITED is a global B2B supplier of premium dietary supplement ingredients. Specializing in vitamins, amino acids, herbal extracts, minerals, and finished dosage forms including softgels, hard capsules, tablets, powders, gummies, and liposomal formulations. 15+ years of industry expertise with GMP-certified manufacturing and global logistics from Hong Kong, United States, and European Union. PURE BY NATURE.
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