Description

Ursodeoxycholic Acid CAS NO 128-13-2 is a secondary bile acid and a key pharmaceutical active ingredient renowned for its hepatoprotective and choleretic properties. Its primary commercial value lies in its critical role as the active pharmaceutical ingredient (API) in medications for treating chronic cholestatic liver diseases, such as primary biliary cholangitis. This high-purity compound is essential for manufacturers in the global pharmaceutical, biotechnology, and advanced research sectors who require a reliable, high-quality supply for formulation and development.

Application

• Pharmaceutical API: Primary active ingredient in oral medications for the treatment of primary biliary cholangitis (PBC), primary sclerosing cholangitis (PSC), and cholesterol gallstone dissolution.
• Hepatoprotective Agent: Used in formulations aimed at protecting liver cells from damage and improving bile flow in various cholestatic conditions.
• Research & Development: Critical standard and reagent in biochemical research focusing on bile acid metabolism, liver physiology, and gastroenterology.
• Cell Culture & Biotechnology: Employed in specialized cell culture media and as a signaling molecule in stem cell differentiation studies.
• Veterinary Medicine: Used in therapeutic applications for liver conditions in companion animals and livestock.
• Dietary Supplement Precursor: Serves as a starting material for the synthesis of specialized nutraceutical ingredients.

Basic Information

Product Name	Ursodeoxycholic Acid
CAS No.	128-13-2
Molecular Formula	C24H40O4
Molecular Weight	392.57 g/mol
Synonyms	Ursodiol; 3α,7β-Dihydroxy-5β-cholan-24-oic Acid; UDCA; Urso; Deoxycholic Acid, 7β-hydroxy-; Cholac; Destolit; Actigall; Ursosan; Ursofalk
EINECS	204-879-3

Quality Control

Our Ursodeoxycholic Acid is manufactured under strict quality management systems. We offer material compliant with major pharmacopoeial standards, including USP and EP monographs. Each batch undergoes comprehensive analytical testing via HPLC, IR, and other validated methods to ensure identity, purity, and the control of specified impurities. A detailed Certificate of Analysis (COA) is provided with every shipment, and DMF/CEP support is available.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry, and well-ventilated area at controlled room temperature (15-25°C). Keep away from strong oxidizing agents.

Specification

Item	Specification
Appearance	White or almost white, crystalline powder
Identification (IR)	Conforms
Identification (HPLC)	Conforms
Assay (HPLC)	98.5% - 101.0% (on anhydrous basis)
Specific Optical Rotation	+59° to +62°
Related Substances (HPLC)	Total impurities: NMT 1.5% Individual unspecified impurity: NMT 0.10% Chenodeoxycholic Acid: NMT 0.3%
Loss on Drying	NMT 1.0%
Residue on Ignition	NMT 0.1%
Heavy Metals	NMT 20 ppm

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.