Ivabradine impurity 92 CAS CATO-C4X-111992

Description

Under current pharmacopoeial and regulatory frameworks, quality-control requirements for this class of reference material explicitly involve the control of targets including Ivabradine impurity 92.

CATO supplies Ivabradine impurity 92 (CAS CATO-C4X-111992), a pharmacopoeial impurity reference standard (molecular formula C15H19NO4, MW 277.32 g/mol) used for the identification and quantification of trace impurities in APIs.

The molecular framework of Ivabradine impurity 92 (C15H19NO4) is characterized by a flavonoid core, an amide group, a hydroxyl group, an ether linkage. In reversed-phase chromatography, its retention is governed primarily by the protonation state of its nitrogen-containing groups, which provides a practical basis for HPLC-UV/DAD or LC-MS method development. The presence of an aromatic ring or conjugated system gives the compound characteristic absorption bands in the UV-Vis region, making it well suited to UV or diode-array detection (DAD).

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), Ivabradine impurity 92 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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