Bilastine impurity 93 CAS CATO-C4X-225393

Description

The occurrence of Bilastine impurity 93 is closely related to a carboxylic acid group, a hydroxyl group, an ether linkage, chlorine substitution, an aromatic ring system in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.

CATO supplies Bilastine impurity 93 (CAS CATO-C4X-225393), a pharmacopoeial impurity reference standard (molecular formula C13H17ClO2, MW 240.73 g/mol) used for the identification and quantification of trace impurities in APIs.

The molecular framework of Bilastine impurity 93 (C13H17ClO2) is characterized by a carboxylic acid group, a hydroxyl group, an ether linkage, chlorine substitution, an aromatic ring system. In reversed-phase chromatography, its retention is governed primarily by its high hydrophobicity (logP), which provides a practical basis for HPLC-UV/DAD or LC-MS method development. 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), Bilastine impurity 93 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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