Ponatinib Impurity 1 CAS 2097674-16-1

Description

The occurrence of Ponatinib Impurity 1 is closely related to a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage, fluorine substitution in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.

CATO supplies Ponatinib Impurity 1 (CAS 2097674-16-1), a pharmacopoeial impurity reference standard (molecular formula C46H46F6N6O2, MW 828.89 g/mol) used for the identification and quantification of trace impurities in APIs.

Structurally, Ponatinib Impurity 1 (C46H46F6N6O2) contains a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage, fluorine substitution. The molecule exhibits a degree of unsaturation (DBE) of 24.0, corresponding to approximately 24 ring(s) or double-bond equivalent(s). With a molecular weight of 828.89 g/mol, it falls into the high-molecular-weight range. Nitrogen-containing functional groups confer excellent ionization efficiency in positive-ion electrospray (ESI) mode, making the compound well suited to LC-MS/MS analysis.

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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