Empagliflozin impurity 265 CAS CATO-C4X-1065265

Description

The occurrence of Empagliflozin impurity 265 is closely related to a steroid core, a hydroxyl group, an ether linkage, chlorine/iodine substitution in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.

CATO supplies Empagliflozin impurity 265 (CAS CATO-C4X-1065265), a pharmacopoeial impurity reference standard (molecular formula C17H16ClIO2, MW 414.67 g/mol) used for the identification and quantification of trace impurities in APIs.

Owing to a steroid core, a hydroxyl group, an ether linkage, chlorine/iodine substitution, Empagliflozin impurity 265 is typically pale yellow to yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 414.67 g/mol — guide the selection of appropriate sample preparation and analytical techniques. The high carbon-to-hydrogen ratio imparts good lipophilicity, allowing liquid-liquid extraction with non-polar solvents such as n-hexane or ethyl acetate.

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), Empagliflozin impurity 265 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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