Ketotifen EP Impurity B (Enantiomer Mixture) CAS 59743-88-3

Description

Compared with other compounds in its class, the molecular weight of 341.47 g/mol gives Ketotifen EP Impurity B (Enantiomer Mixture) distinctive chromatographic separation conditions and mass-spectrometry parameter settings.

CATO supplies Ketotifen EP Impurity B (Enantiomer Mixture) (CAS 59743-88-3), a pharmacopoeial impurity reference standard (molecular formula C20H23NO2S, MW 341.47 g/mol) used for the identification and quantification of trace impurities in APIs.

Owing to a steroid core, an amide group, a sulfone group, a hydroxyl group, an ether linkage, Ketotifen EP Impurity B (Enantiomer Mixture) is typically pale yellow to yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 341.47 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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