Obeticholic Acid Impurity 8 CAS 1908444-28-9

Description

The occurrence of Obeticholic Acid Impurity 8 is closely related to a carboxylic acid group, a hydroxyl group, an ether linkage, a polycyclic aromatic system in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.

CATO supplies Obeticholic Acid Impurity 8 (CAS 1908444-28-9), a pharmacopoeial impurity reference standard (molecular formula C52H86O7, MW 823.24 g/mol) used for the identification and quantification of trace impurities in APIs.

Obeticholic Acid Impurity 8 (C52H86O7) contains a carboxylic acid group, a hydroxyl group, an ether linkage, a polycyclic aromatic system. The carboxyl group imparts weak acidity; these physicochemical properties determine the optimal preparation and storage of its standard solutions. The aromatic system may exhibit native fluorescence, enabling detection with a fluorescence detector (FLD).

This reference standard supports related-substances testing and method development in line with ICH Q3A/Q3B guidance on impurity control, and is suitable for system suitability testing and forced-degradation studies.

As a certified reference material (CRM), Obeticholic Acid Impurity 8 meets the metrological traceability requirements of ISO/IEC 17025 laboratories. Batch-to-batch consistency is monitored via control charts to guarantee comparable assigned values across lots.

Physical & Chemical Properties

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