Quetiapine EP Impurity H CAS 1076199-40-0

Description

The occurrence of Quetiapine EP Impurity H is closely related to a steroid core, an amide group, a sulfone group, a hydroxyl group, an ether linkage in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.

CATO supplies Quetiapine EP Impurity H (CAS 1076199-40-0), a pharmacopoeial impurity reference standard (molecular formula C21H25N3O3S, MW 399.51 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, Quetiapine EP Impurity H is typically pale yellow to yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 399.51 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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