Nilotinib Hydrochloride Monohydrate EP Impurity A CAS 641571-11-1

Description

The occurrence of Nilotinib Hydrochloride Monohydrate EP Impurity A is closely related to a nitrogen-containing heterocyclic scaffold, a nitrile group, fluorine substitution in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.

CATO supplies Nilotinib Hydrochloride Monohydrate EP Impurity A (CAS 641571-11-1), a pharmacopoeial impurity reference standard (molecular formula C11H10F3N3, MW 241.21 g/mol) used for the identification and quantification of trace impurities in APIs.

The molecular framework of Nilotinib Hydrochloride Monohydrate EP Impurity A (C11H10F3N3) is characterized by a nitrogen-containing heterocyclic scaffold, a nitrile group, fluorine substitution. In reversed-phase chromatography, its retention is governed primarily by its high hydrophobicity (logP), which provides a practical basis for HPLC-UV/DAD or LC-MS method development. The aromatic system may exhibit native fluorescence, enabling detection with a fluorescence detector (FLD).

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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