Drospirenone Impurity N4 CAS 2963-69-1

Description

Compared with other compounds in its class, the molecular weight of 320.42 g/mol gives Drospirenone Impurity N4 distinctive chromatographic separation conditions and mass-spectrometry parameter settings.

CATO supplies Drospirenone Impurity N4 (CAS 2963-69-1), a pharmacopoeial impurity reference standard (molecular formula C19H28O4, MW 320.42 g/mol) used for the identification and quantification of trace impurities in APIs.

The molecular framework of Drospirenone Impurity N4 (C19H28O4) is characterized by a steroid core, a hydroxyl group, an ether linkage. 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), Drospirenone Impurity N4 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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