Lapatinib Impurity 2 CAS 202197-25-9

Description

Compared with other compounds in its class, the molecular weight of 217.24 g/mol gives Lapatinib Impurity 2 distinctive chromatographic separation conditions and mass-spectrometry parameter settings.

CATO supplies Lapatinib Impurity 2 (CAS 202197-25-9), a pharmacopoeial impurity reference standard (molecular formula C13H12FNO, MW 217.24 g/mol) used for the identification and quantification of trace impurities in APIs.

Owing to a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage, fluorine substitution, Lapatinib Impurity 2 is typically pale yellow to yellow low-melting solid. Its solid-state physicochemical attributes — including a molecular weight of 217.24 g/mol — guide the selection of appropriate sample preparation and analytical techniques. 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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