Ursodeoxycholic Acid

Product Overview

Ursodeoxycholic Acid, commonly known as UDCA or Ursodiol, represents a critical secondary bile acid utilized extensively within the global pharmaceutical industry. Our high-purity grade material serves as an essential intermediate for the development of hepatoprotective medications and gallstone dissolution therapies. Manufactured under strict Good Manufacturing Practice conditions, this compound offers exceptional stability and bioavailability for downstream formulation processes. We prioritize consistency across all batches to support large-scale production needs.

Chemically defined as 3α,7β-Dihydroxy-5β-cholan-24-oic acid, this stereoisomer exhibits unique physicochemical properties that distinguish it from other bile acids. The specific configuration at the 7-position hydroxyl group is crucial for its therapeutic efficacy and reduced cytotoxicity compared to endogenous bile acids. Our production ensures consistent stereochemical purity to meet rigorous international pharmacopoeia standards. This molecular precision is vital for ensuring patient safety and regulatory compliance in final drug products.

Technical Specifications

Quality assurance is paramount in pharmaceutical supply chains. Each batch undergoes comprehensive analytical testing to verify compliance with EP8.0 standards. The following table outlines key performance indicators and test results typical of our manufacturing output. We maintain tight controls on impurities such as lithocholic acid to ensure safety.

Industrial Applications

The primary application of Ursodeoxycholic Acid lies in the treatment of cholesterol gallstones and various cholestatic liver diseases. It functions by reducing cholesterol absorption in the intestine and decreasing hepatic cholesterol secretion. Furthermore, it protects liver cells from damage caused by toxic bile acids, making it invaluable for managing primary biliary cholangitis. Clinical studies continue to support its role in improving liver enzyme profiles.

Beyond direct therapeutic use, this chemical serves as a vital building block for synthesizing novel bile acid derivatives. Researchers utilize our high-purity material to develop next-generation treatments for non-alcoholic steatohepatitis and other metabolic disorders. The low impurity profile ensures minimal side effects in final drug products. Our supply chain supports both clinical trial materials and commercial manufacturing scales.

Storage and Handling

To maintain optimal quality, store this material in a tightly closed container within a cool, dry environment. Protect from moisture and incompatible substances. Proper handling procedures should be followed to ensure safety during industrial processing and laboratory use. Contact our technical team for detailed safety data sheets and transportation guidelines. We recommend regular quality audits for long-term storage facilities.