Eplerenone EP Impurity A CAS 209253-67-8

Description

Under current pharmacopoeial and regulatory frameworks, quality-control requirements for this class of reference material explicitly involve the control of targets including Eplerenone EP Impurity A.

CATO supplies Eplerenone EP Impurity A (CAS 209253-67-8), a pharmacopoeial impurity reference standard (molecular formula C23H28O5, MW 384.47 g/mol) used for the identification and quantification of trace impurities in APIs.

The molecular framework of Eplerenone EP Impurity A (C23H28O5) is characterized by a flavonoid core, a hydroxyl group, an ether linkage. In reversed-phase chromatography, its retention is governed primarily by the polarity and ionization state of its functional groups, 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), Eplerenone EP Impurity A 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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