Ivabradine Impurity 55 CAS 35202-54-1

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 55.

CATO supplies Ivabradine Impurity 55 (CAS 35202-54-1), a pharmacopoeial impurity reference standard (molecular formula C11H11NO2, MW 189.21 g/mol) used for the identification and quantification of trace impurities in APIs.

Owing to an amino-acid-derived structure, an amide group, a hydroxyl group, an ether linkage, Ivabradine Impurity 55 is typically off-white to pale yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 189.21 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), Ivabradine Impurity 55 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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