Active Pharmaceutical Ingredient

Ursodiol (Ursodeoxycholic Acid)

Also known as: Ursodeoxycholic Acid; UDCA; Actigall; Urso Forte

CAS: 128-13-2Hepatoprotective APIBile Acid / UDCAIP / BP / EP / USPGMP CertifiedAurangabad, India
Ursodiol (Ursodeoxycholic Acid) API — Mediocon Inc
Ursodiol (Ursodeoxycholic Acid) — Pharmaceutical Grade API | Mediocon Inc, Aurangabad, Maharashtra, India

Product Overview

CAS No: 128-13-2  |  MF: C₂₄H₄₀O₄  |  MW: 392.57 g/mol

Ursodiol (Ursodeoxycholic Acid) is a high-purity Active Pharmaceutical Ingredient supplied by Mediocon Inc conforming to IP / BP / EP / USP specifications. Manufactured at our GMP-certified facility in Aurangabad, Maharashtra, India.

Ursodiol (UDCA) is a naturally occurring bile acid used to dissolve gallstones, treat primary biliary cholangitis (PBC), and protect liver cells from toxic bile acids. It reduces hepatic cholesterol secretion and suppresses intestinal absorption of cholesterol.

Key Features

  • High-purity pharmaceutical grade API
  • IP / BP / EP / USP compliant
  • Full CoA and MSDS documentation
  • GMP certified manufacturing facility

Applications

  • Primary biliary cholangitis (PBC)
  • Cholesterol gallstone dissolution
  • Non-alcoholic steatohepatitis (NASH)
  • Liver transplant post-operative care

Why Choose Mediocon

  • ISO 9001:2015 & GMP certified manufacturing
  • Consistent batch-to-batch quality with full CoA
  • Export-ready documentation: COO, MSDS, DMF
  • Flexible MOQ for both R&D and commercial scale
  • Dedicated QA support for regulatory filings

Product Specifications

Product NameUrsodiol (Ursodeoxycholic Acid)
Also Known AsUrsodeoxycholic Acid; UDCA; Actigall; Urso Forte
CAS Number128-13-2
Molecular FormulaC₂₄H₄₀O₄
Molecular Weight392.57 g/mol
CategoryBile Acid / Hepatoprotective API
AppearanceWhite to off-white crystalline powder
SolubilityPractically insoluble in water; slightly soluble in ethanol; soluble in glacial acetic acid
GradeIP / BP / EP / USP

Analytical Specifications

ParameterSpecification
AssayNLT 98.0%
Loss on DryingNMT 0.5%
Heavy MetalsNMT 20 ppm
Residue on IgnitionNMT 0.1%
Microbial LimitsComplies with pharmacopoeia
IdentificationIR, HPLC Compliant
Batch No.URS/24033043
Mfg DateMAR 2026
Exp DateFEB 2031
Packing25 kg HDPE drums / as per requirement
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