Obeticholic Acid is a semi-synthetic bile acid analogue that is used in the treatment of primary biliary cholangitis. Its impurity profile includes structurally related analogs, residual solvents, and degradation products formed under stress conditions such as hydrolysis, oxidation, and photolysis. Typical degradation pathways involve oxidative breakdown of the steroidal nucleus, hydrolytic cleavage of ester bonds, and rearrangement of hydroxyl substituents. These impurities may affect the drug’s potency, stability, and safety. All impurities are structurally characterized and qualified according to ICH guidelines for toxicological assessment and analytical validation.
Pharmacopeial and non-pharmacopeial Obeticholic Acid impurity compounds are available in compliance with European Pharmacopoeia (EP) specifications. These standards support analytical method development, impurity profiling, and long-term stability studies. EP traceable materials are supplied with validated analytical data, including purity, structural confirmation, and spectral characterization.
Structurally related compounds and synthetic analogs associated with Obeticholic Acid are included for impurity identification, toxicological qualification, and regulatory submission. These related substances are used in forced degradation studies, genotoxicity assessments, and impurity threshold evaluations. They are essential for understanding the impurity profile and ensuring compliance with regulatory limits.
Obeticholic Acid impurity reference standards are provided with validated analytical data, including purity, NMR, MS, and full Certificates of Analysis. These standards are used in pharmaceutical research, method validation, and GMP-compliant quality control. EP/USP traceable entries are available upon request and are routinely re-tested to ensure consistency and reliability.
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