Cinnarizine EP Impurity A CAS 841-77-0

Description

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

CATO supplies Cinnarizine EP Impurity A (CAS 841-77-0), a pharmacopoeial impurity reference standard (molecular formula C17H20N2, MW 252.35 g/mol) used for the identification and quantification of trace impurities in APIs.

Owing to a nitrogen-containing heterocyclic scaffold, a nitrile group, Cinnarizine EP Impurity A is typically pale yellow to yellow low-melting solid. Its solid-state physicochemical attributes — including a molecular weight of 252.35 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.

The assigned purity is verified by mass-balance and quantitative NMR (qNMR) approaches, with the expanded uncertainty reported at a 95% confidence level (k=2). Batch homogeneity and stability are independently assessed for every lot.

Physical & Chemical Properties

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