Description

Ursodeoxycholic Acid Sodium Salt is the sodium salt form of the hydrophilic bile acid ursodeoxycholic acid (UDCA). This compound is a critical pharmaceutical intermediate and active ingredient, valued for its hepatoprotective and choleretic properties. It is primarily utilized in the pharmaceutical industry for the production of medications targeting cholestatic liver diseases and for cholesterol gallstone dissolution. Global manufacturers and R&D facilities rely on high-purity grades of this material for both commercial drug formulation and advanced clinical research.

Application

• Pharmaceutical Active Ingredient (API): Core component in prescription medications for primary biliary cholangitis (PBC), primary sclerosing cholangitis (PSC), and other cholestatic conditions.
• Gallstone Therapy: Used in oral dissolution therapy for radiolucent, cholesterol-rich gallstones in patients who are not candidates for surgery.
• Hepatoprotective Formulations: Incorporated into liver-protectant drugs and dietary supplements aimed at supporting liver function and health.
• Research & Development: Essential reference standard and building block in biomedical research for studying bile acid metabolism, liver physiology, and novel therapeutic pathways.
• Biochemical Reagent: Used in cell culture and in vitro studies to modulate membrane fluidity and as a signaling molecule.
• Veterinary Pharmaceuticals: Applied in veterinary medicine for the treatment of hepatobiliary disorders in companion and livestock animals.

Basic Information

Product Name	Ursodeoxycholic Acid Sodium Salt
CAS No.	31687-65-7
Molecular Formula	C24H39NaO4
Molecular Weight	414.56 g/mol
Synonyms	Ursodiol Sodium; Sodium Ursodeoxycholate; UDCA Sodium Salt; 3α,7β-Dihydroxy-5β-cholan-24-oic Acid Sodium Salt; Sodium 3α,7β-dihydroxy-5β-cholan-24-oate; Urso Sodium; Cholacide Sodium; Deursil Sodium
EINECS	Contact for details

Quality Control

Our Ursodeoxycholic Acid Sodium Salt is manufactured under strict quality management systems. Production adheres to current Good Manufacturing Practice (cGMP) principles, and the material is routinely tested to meet stringent pharmacopeial standards, including USP and EP monographs where applicable. Every batch is supported by a comprehensive Certificate of Analysis (COA) detailing purity, identity, and impurity profiles to ensure consistency and reliability for your critical applications.

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). This material is hygroscopic (moisture-sensitive); the container must be kept tightly sealed to protect from atmospheric moisture.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single impurity ≤ 1.0%
Specific Rotation	+28.0° to +32.0° (c=1, in ethanol)
Microbial Enumeration	Meets USP <61> requirements

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