NINGBO INNO PHARMCHEM CO.,LTD. is a trusted manufacturer and supplier of high-quality pharmaceutical raw materials, proudly presenting Ursodeoxycholic Acid (UDCA), CAS 128-13-2. This critical compound is indispensable in the treatment of various hepatobiliary diseases, offering significant therapeutic benefits to patients worldwide.

Understanding Ursodeoxycholic Acid (UDCA)

Ursodeoxycholic Acid, or UDCA, is a naturally occurring bile acid found in small quantities in human bile. While originally isolated from bear bile, the commercially available product is typically synthesized to ensure purity, consistency, and scalability. It is an epimeric stereoisomer of chenodeoxycholic acid (CDCA), another bile acid, but possesses distinct pharmacological properties that make it particularly valuable in clinical practice.

Product Specifications and Properties

Our Ursodeoxycholic Acid (CAS 128-13-2) is supplied as a white or almost white powder. It is characterized by its odorless nature and slightly bitter taste. Key physical and chemical properties include:
• CAS Number: 128-13-2
• Molecular Formula: C24H40O4
• Molecular Weight: 392.57 g/mol
• Appearance: White or almost white powder
• Melting Point: Typically ranges from 194ºC to 202ºC (with high-purity material often showing a sharper range around 200-204ºC)
• Solubility: Soluble in ethanol, glacial acetic acid, and sodium hydroxide test solution; insoluble in chloroform.
• Assay: Our product meets stringent quality standards, typically ranging from 99.0% to 101.0% purity.

Mechanism of Action and Therapeutic Benefits

Ursodeoxycholic Acid exerts its therapeutic effects through multiple mechanisms within the hepatobiliary system. Its primary actions include:
1. Reduction of Cholesterol Saturation in Bile: UDCA decreases the secretion of cholesterol by the liver into bile. This leads to a reduction in the cholesterol saturation index of bile, making it less likely for cholesterol to crystallize and form stones.
2. Dissolution of Cholesterol Gallstones: By reducing bile saturation and increasing the solubility of cholesterol in bile, UDCA can gradually dissolve existing cholesterol gallstones. This is particularly effective for small, non-calcified stones in a functioning gallbladder.
3. Modulation of Bile Acid Pool: UDCA becomes a significant fraction of the total bile acid pool. As a more hydrophilic bile acid compared to native hydrophobic bile acids, it is thought to protect liver cells from the potential toxic effects of excessive hydrophobic bile acids.
4. Improvement of Bile Flow: UDCA can promote bile secretion and relax the sphincter of Oddi, facilitating bile flow and the passage of small stones or sludge.
5. Immunomodulatory and Cytoprotective Effects: In chronic cholestatic liver diseases like Primary Biliary Cirrhosis (PBC), UDCA has shown benefits beyond just affecting bile composition. It is believed to have immunomodulatory properties and protect hepatocytes and cholangiocytes from bile acid toxicity and inflammatory damage.

Key Applications in Clinical Practice

The efficacy of Ursodeoxycholic Acid has made it a cornerstone treatment for several conditions:
• Cholesterol Gallstones: It is the primary non-surgical option for dissolving radiolucent (cholesterol) gallstones, especially in patients who are not candidates for surgery or prefer a non-invasive approach.
• Primary Biliary Cirrhosis (PBC): UDCA is the standard first-line therapy for PBC, slowing disease progression and improving liver function markers.
• Chronic Hepatitis: It is used adjunctively in certain types of chronic hepatitis, potentially improving liver enzyme levels.
• Bile Reflux Gastritis: UDCA can help alleviate symptoms by altering the composition of refluxed bile.
• Other Cholestatic Liver Diseases: It is sometimes used in other conditions characterized by impaired bile flow.

Quality Assurance and Supply Reliability

At NINGBO INNO PHARMCHEM CO.,LTD., we understand the critical importance of quality and consistency in pharmaceutical raw materials. Our Ursodeoxycholic Acid is manufactured under strict quality control protocols, utilizing advanced analytical techniques to ensure high purity, low heavy metal content (typically ≤20ppm), and absence of undesirable impurities. A Certificate of Analysis (COA) and Material Safety Data Sheet (MSDS) are available for all batches.

We maintain a significant production capacity to meet the demands of the global pharmaceutical market, ensuring a stable and reliable supply for our clients. Our packaging options include 1kg and 5kg aluminum bags, and 25kg drums, designed to maintain product integrity during storage and transportation. We recommend storage below 25ºC, protected from light, to preserve quality over a shelf life of typically 2 years.

As a leading Ursodeoxycholic Acid manufacturer, NINGBO INNO PHARMCHEM CO.,LTD. is committed to providing competitive pricing and excellent service. For pharmaceutical companies and formulators looking to buy Ursodeoxycholic Acid or purchase Ursodeoxycholic Acid in bulk, we offer a dependable source of high-quality API. Our extensive experience as an Ursodeoxycholic Acid supplier ensures that we can meet diverse requirements, offering customized solutions such as granulation or superfine pulverization to optimize the material for specific applications, including capsule and tablet filling or enhancing solubility.

Contact NINGBO INNO PHARMCHEM CO.,LTD. today to learn more about our Ursodeoxycholic Acid offering and how we can support your manufacturing needs. Discover our competitive Ursodeoxycholic Acid price and partner with a reliable supplier dedicated to quality and customer satisfaction.