Abemaciclib Impurity 78 CAS CATO-C4X-293778

Description

Under current pharmacopoeial and regulatory frameworks, quality-control requirements for this class of reference material explicitly involve the control of targets including Abemaciclib Impurity 78.

CATO supplies Abemaciclib Impurity 78 (CAS CATO-C4X-293778), a pharmacopoeial impurity reference standard (molecular formula C16H20ClFN6HCl, MW 387.28 g/mol) used for the identification and quantification of trace impurities in APIs.

Abemaciclib Impurity 78 (C16H20ClFN6HCl) contains a nitrogen-containing heterocyclic scaffold, a nitrile group, fluorine/chlorine substitution. Halogen substitution raises its density and boiling point; these physicochemical properties determine the optimal preparation and storage of its standard solutions. 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.

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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