TCS Industries Limited (China-sourced API supplier) supplies Ursodeoxycholic Acid — API CAS 128-13-2 for pharmaceutical B2B procurement — COA, MSDS, and technical documentation available on request.
> Overview
| Product Name | Ursodeoxycholic Acid |
|---|---|
| Structural Formula |  |
| CAS Number | 128-13-2 |
| Molecular Formula | C₂₄H₄₀O₄ |
| Molecular Weight | 392.6 g/mol |
| InChIKey | RUDATBOHQWOJDD-UZVSRGJWSA-N |
| SMILES | Available on request where applicable |
| Appearance | White crystalline powder, bitter taste |
| Purity / Grade | By agreed specification and batch COA |
| Storage | Room temperature, dry conditions |
Ursodeoxycholic Acid (CAS 128-13-2, UDCA) is a hydrophilic bile acid with the formula C₂₄H₄₀O₄ (MW 392.57). UDCA constitutes about 3% of the human bile acid pool naturally. It displaces hydrophobic toxic bile acids, stabilizes hepatocyte membranes, and has cytoprotective and immunomodulatory effects. UDCA is used for primary biliary cholangitis (PBC), gallstone dissolution, and cholestatic liver diseases.
TCS Industries Limited, a Hong Kong-based trading and sourcing company, supplies Ursodeoxycholic Acid API in pharmaceutical grade for global procurement programs.
> Applications
Primary biliary cholangitis and cholestatic liver disease
UDCA 13–15 mg/kg/day is the first-line treatment for primary biliary cholangitis (PBC), where it slows disease progression and improves transplant-free survival. It reduces toxic hydrophobic bile acid accumulation through competitive displacement, stabilizes cell membranes (phospholipid-rich mixed micelles), and has anti-apoptotic and immunomodulatory effects. Poupon et al. (N Engl J Med, 1991, 324:1548–1554) demonstrated that UDCA significantly improved liver biochemistry and histology in patients with primary biliary cholangitis in the first randomized controlled trial.
Gallstone dissolution and pregnancy cholestasis
UDCA 8–10 mg/kg/day dissolves cholesterol gallstones (<20 mm, radiolucent) by reducing cholesterol saturation of bile. It is also used for intrahepatic cholestasis of pregnancy (ICP), cystic fibrosis-associated liver disease, and primary sclerosing cholangitis.
> Sourcing & Supply
TCS Industries Limited supports development, qualification and commercial purchasing discussions for Ursodeoxycholic Acid with buyers in Australia, New Zealand, Canada and South Korea.
- Evaluation and commercial quantities: 1 kg samples for formulation development; 5 kg and 25 kg for production. Pharmaceutical (USP/Ph.Eur.) grade. Synthetic and semi-synthetic routes available. DMF reference letters provided.
- Pallet quantities and production campaigns: repeat supply is coordinated against packaging, lead time, annual demand and destination-market import requirements.
> Quality & Documentation
Key specification parameters include assay (≥99.0%), related substances (chenodeoxycholic acid ≤0.5%, lithocholic acid ≤0.05%), specific optical rotation, loss on drying, residue on ignition, heavy metals, and microbial limits. White crystalline powder. Practically insoluble in water, soluble in ethanol and glacial acetic acid. Melting point 200–204 °C. Meets USP (Ursodiol), Ph.Eur. (Acidum ursodeoxycholicum), and JP. COA and MSDS are standard.
> Packaging
UDCA is a white crystalline powder. Standard packaging includes double PE-lined foil bags in fibre drums (1 kg, 5 kg, or 25 kg). Store at controlled room temperature (15–25 °C). Protect from moisture. Shelf life is typically 36 months. Labels and documents are checked before dispatch.
> Pricing & MOQ
Pricing is quoted by specification, packaging and destination. Common commercial discussions use 25 kg bag/drum formats, pallet quantities and production-campaign planning; smaller samples may be reviewed for qualified formulation teams.
> Regulatory & Compounding Context
UDCA is monographed in USP (Ursodiol), Ph.Eur. (Acidum ursodeoxycholicum), BP, and JP. FDA-approved in 1987 (Actigall for gallstones) and 1997 (Urso for PBC). EMA-authorized. On the WHO Model List of Essential Medicines. Off-patent with multiple generic approvals. DMF support available.
> Alias Index
- INN: Ursodeoxycholic acid
- CAS Number: 128-13-2
- Formula: C₂₄H₄₀O₄ (MW 392.57)
- USP name: Ursodiol
- Brand names: Urso, Actigall, Ursofalk
- ATC code: A05AA02
- Commercial request terms: ursodeoxycholic acid API, UDCA, ursodiol, bile acid API, PBC treatment, TCS Industries Limited
> FAQ
How does UDCA protect hepatocytes?
UDCA displaces hydrophobic bile acids (deoxycholic, chenodeoxycholic) from the bile acid pool, reducing their cytotoxic effects on hepatocyte membranes. It also stabilizes membranes by forming mixed micelles with phospholipids, stimulates hepatobiliary secretion (choleresis), and has direct anti-apoptotic and immunomodulatory effects on hepatocytes.
What documents are available for Ursodeoxycholic Acid orders?
COA and MSDS are standard for commercial discussions. COO, packing list, invoice and other import-support documents can be arranged according to order scope.
Do you supply Ursodeoxycholic Acid to Australia and Canada?
Yes. We support B2B buyers in Australia, New Zealand, Canada and South Korea, subject to route and document review.
Do you supply New Zealand and South Korea?
Yes. We review Australia, New Zealand, Canada and South Korea for project supply, import documents, packaging and logistics planning before quotation.
How long does gallstone dissolution take?
UDCA dissolves cholesterol gallstones at approximately 1 mm/month. Stones <5 mm dissolve in ~6 months; 10–15 mm stones may take 12–24 months. Only radiolucent (cholesterol) stones in a functioning gallbladder respond. Calcified and pigment stones do not dissolve. Recurrence rate is ~50% within 5 years after stopping treatment.
Is UDCA safe in pregnancy?
UDCA is used for intrahepatic cholestasis of pregnancy (ICP) to reduce bile acid levels and pruritus. It is considered safe in the second and third trimesters (limited first-trimester data). It reduces maternal serum bile acids and may reduce the risk of adverse fetal outcomes associated with elevated bile acid levels.
Can you arrange samples before commercial purchasing?
Samples or evaluation quantities may be reviewed for qualified buyers after target specification, application and destination-market requirements are clarified.
How is Ursodeoxycholic Acid packaged for export?
Packaging is confirmed by quantity and material properties. Typical options include foil bags, HDPE containers, fibre drums, 25 kg bags or palletized export packaging.
Can buyer-defined specifications be reviewed?
Yes. Send the specification, methods, impurity limits and required documents. TCS can review feasibility before confirming quotation and lead time.
What payment terms are normally used?
Standard payment is 100% T/T before dispatch unless a different arrangement has been approved for an established commercial account.
What lead time should buyers expect?
Lead time depends on stock, batch size, document scope and destination. Available stock can move faster; made-to-order or pallet programs require longer planning.
Is a DMF available?
Yes. TCS sources UDCA from manufacturers who maintain active DMFs with the FDA and ASMF/CEP with EMA. Synthetic and semi-synthetic production routes from cholic acid are available. COA, stability data, and DMF reference letters provided.
Last reviewed: June 2026
Evaluation and research orders (≤10 kg) are shipped with COA, MSDS, and certificate of origin. Bulk commercial orders (>10 kg) qualify for volume pricing with a full technical documentation package available on request.
> Request a Quote
If your team already has a target application, estimated quantity, destination market, or documentation requirements, send those details so the commercial response can be prepared more efficiently.