Revefenacin Impurity N2 CAS 115293-14-6

Description

Under current pharmacopoeial and regulatory frameworks, quality-control requirements for this class of reference material explicitly involve the control of targets including Revefenacin Impurity N2.

CATO supplies Revefenacin Impurity N2 (CAS 115293-14-6), a pharmacopoeial impurity reference standard (molecular formula C25H20N2O, MW 364.44 g/mol) used for the identification and quantification of trace impurities in APIs.

The molecular framework of Revefenacin Impurity N2 (C25H20N2O) is characterized by a steroid core, an amide group, 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 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), Revefenacin Impurity N2 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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