NINGBO INNO PHARMCHEM CO.,LTD. Announces Availability of High Purity Obeticholic Acid (OCA) Powder

NINGBO INNO PHARMCHEM CO.,LTD. is pleased to announce the availability of high purity Obeticholic Acid (OCA) powder, a critical active pharmaceutical ingredient (API). Identified by its CAS number 459789-99-2, Obeticholic Acid is a modified bile acid synthesized from chenodeoxycholic acid. It serves as a potent agonist of the farnesoid X receptor (FXR), a nuclear receptor highly expressed in the liver and intestine that plays a key role in regulating bile acid metabolism and synthesis, as well as lipid and glucose homeostasis.

The material supplied by NINGBO INNO PHARMCHEM CO.,LTD. meets stringent quality standards, presenting as a white or off-white solid powder. Analytical results confirm a high assay of 99.80%, exceeding the minimum requirement of 98.0%. Detailed quality control testing is performed on every batch to ensure compliance with internal standards, covering aspects such as appearance, identification (by IR and HPLC), solubility profile, water content (typically low at 1.42%), heavy metals (undetected below 20ppm), residue on ignition (minimal at 0.07%), and residual solvents (undetected for Methanol, Ethanol, Butyl Acetate, n-Heptane). Furthermore, related substances and impurities are meticulously controlled, with Impurity A at 0.28% and other specified impurities below detection limits, resulting in a low total impurities level of 0.28% against a standard limit of 1.00%. This rigorous testing protocol underscores NINGBO INNO PHARMCHEM CO.,LTD.'s commitment to providing APIs of exceptional quality and purity, essential for their downstream pharmaceutical applications.

The primary established therapeutic application for Obeticholic Acid is in the treatment of Primary Biliary Cholangitis (PBC). PBC is a chronic, progressive autoimmune disease affecting the bile ducts in the liver, which can lead to cirrhosis and liver failure. Obeticholic Acid, marketed under various trade names globally, is typically used as a second-line therapy for adults with PBC who have had an inadequate response to or are intolerant of ursodeoxycholic acid (UDCA), the standard first-line treatment. Its action as an FXR agonist helps reduce the synthesis of bile acids in the liver and improve bile flow, thus alleviating symptoms and potentially slowing disease progression.

Beyond PBC, Obeticholic Acid has also been extensively investigated for the treatment of Non-Alcoholic Steatohepatitis (NASH), a severe form of non-alcoholic fatty liver disease characterized by liver inflammation and damage. While clinical trials showed some positive effects on liver fibrosis, regulatory approval for NASH has faced challenges in certain regions, highlighting the complexity of this disease and the development of effective treatments. Nevertheless, the research conducted into Obeticholic Acid's effects on NASH has provided valuable insights into the potential of FXR agonists in metabolic and liver diseases.

NINGBO INNO PHARMCHEM CO.,LTD. understands the critical role that high-quality APIs play in the development and manufacturing of safe and effective pharmaceuticals. Their production processes adhere to strict quality management systems, capable of meeting international standards such as GMP, FDA, and ISO requirements. This ensures that the Obeticholic Acid powder supplied is suitable for pharmaceutical manufacturing, providing reliability and consistency to their clients worldwide.

The solubility characteristics of Obeticholic Acid, being freely soluble in methanol, ethanol, and THF, soluble in ethyl acetate, slightly soluble in water and acetone, and insoluble in hexane and toluene, are important considerations for formulators developing finished drug products. NINGBO INNO PHARMCHEM CO.,LTD. provides comprehensive technical data and support to assist customers with their formulation challenges.

Storage recommendations for Obeticholic Acid include preserving the material in tight, light-resistant containers in a cool place. Proper storage conditions are vital to maintain the stability and integrity of the API over its shelf life, which is typically warranted for a specific period (often 24 months under recommended conditions), as confirmed by NINGBO INNO PHARMCHEM CO.,LTD.'s stability testing programs.

As a dedicated API supplier, NINGBO INNO PHARMCHEM CO.,LTD. is equipped to handle various order sizes, from small laboratory quantities for research and development to larger bulk quantities for commercial production. They are committed to maintaining a robust supply chain to meet the global demand for this important API.

The development and synthesis of complex APIs like Obeticholic Acid require significant expertise in organic chemistry and process development. NINGBO INNO PHARMCHEM CO.,LTD. leverages its experienced research and development team and manufacturing capabilities to produce high-quality Obeticholic Acid consistently and efficiently.

For pharmaceutical companies and researchers seeking a reliable source of high purity Obeticholic Acid powder (CAS 459789-99-2), NINGBO INNO PHARMCHEM CO.,LTD. stands as a trusted partner. Their commitment to quality, technical excellence, and customer service ensures they can meet the specific needs of the pharmaceutical industry.

Inquiries regarding the availability, specifications, and lead times for Obeticholic Acid powder can be directed to NINGBO INNO PHARMCHEM CO.,LTD.'s sales team. They offer competitive options for those looking to buy or purchase this API. As a direct manufacturer and supplier, NINGBO INNO PHARMCHEM CO.,LTD. can provide detailed information on the price, minimum order quantity, and global shipping capabilities.

Choosing a reputable manufacturer and supplier for APIs like Obeticholic Acid is paramount to ensuring the quality and safety of the final medicinal product. NINGBO INNO PHARMCHEM CO.,LTD. invites potential customers to discuss their requirements and learn more about their high-quality Obeticholic Acid and comprehensive service offerings. Trust NINGBO INNO PHARMCHEM CO.,LTD. for your critical API sourcing needs.