Osimertinib Impurity 117 CAS CATO-C4X-2045117

Description

The occurrence of Osimertinib Impurity 117 is closely related to a steroid core, an amide group, a sulfone group, a hydroxyl group, an ether linkage in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.

CATO supplies Osimertinib Impurity 117 (CAS CATO-C4X-2045117), a pharmacopoeial impurity reference standard (molecular formula C29H37N7O5S, MW 595.71 g/mol) used for the identification and quantification of trace impurities in APIs.

Osimertinib Impurity 117 (C29H37N7O5S) contains a steroid core, an amide group, a sulfone group, a hydroxyl group, an ether linkage. It is notably hygroscopic, the carboxyl group imparts weak acidity; these physicochemical properties determine the optimal preparation and storage of its standard solutions. The presence of an aromatic ring or conjugated system gives the compound characteristic absorption bands in the UV-Vis region, making it well suited to UV or diode-array detection (DAD).

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.

CATO manufactures Osimertinib Impurity 117 under ISO 17034:2016 accreditation with dual CNAS and ANAB accreditation. Each batch is characterized by orthogonal methods and supplied with a full Certificate of Analysis (COA), ensuring metrological traceability.

Physical & Chemical Properties

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