Apixaban Impurity 101 CAS 2219376-48-2

Description

Compared with other compounds in its class, the molecular weight of 252.65 g/mol gives Apixaban Impurity 101 distinctive chromatographic separation conditions and mass-spectrometry parameter settings.

CATO supplies Apixaban Impurity 101 (CAS 2219376-48-2), a pharmacopoeial impurity reference standard (molecular formula C11H9ClN2O3, MW 252.65 g/mol) used for the identification and quantification of trace impurities in APIs.

Structurally, Apixaban Impurity 101 (C11H9ClN2O3) contains a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage, chlorine substitution. The molecule exhibits a degree of unsaturation (DBE) of 8.0, corresponding to approximately 8 ring(s) or double-bond equivalent(s). With a molecular weight of 252.65 g/mol, it falls into the medium-molecular-weight range. 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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