Pregabalin Impurity 58 CAS CATO-C4X-131258

Description

The occurrence of Pregabalin Impurity 58 is closely related to an amide group, a carboxylic acid group, a hydroxyl group, an ether linkage, chlorine substitution in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.

CATO supplies Pregabalin Impurity 58 (CAS CATO-C4X-131258), a pharmacopoeial impurity reference standard (molecular formula C11H23NO2HCl, MW 237.77 g/mol) used for the identification and quantification of trace impurities in APIs.

Owing to an amide group, a carboxylic acid group, a hydroxyl group, an ether linkage, chlorine substitution, Pregabalin Impurity 58 is typically white to off-white crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 237.77 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), Pregabalin Impurity 58 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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