Abemaciclib Impurity 101 CAS CATO-C4X-2937101

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 101.

CATO supplies Abemaciclib Impurity 101 (CAS CATO-C4X-2937101), a pharmacopoeial impurity reference standard (molecular formula C46H46F4N14, MW 870.94 g/mol) used for the identification and quantification of trace impurities in APIs.

Owing to a nitrogen-containing heterocyclic scaffold, a nitrile group, fluorine substitution, Abemaciclib Impurity 101 is typically pale yellow to yellow amorphous powder. Its solid-state physicochemical attributes — including a molecular weight of 870.94 g/mol — guide the selection of appropriate sample preparation and analytical techniques. Halogen substitution (F/Cl/Br/I) produces a distinctive isotope pattern in mass spectrometry, a valuable aid for qualitative confirmation.

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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