Brexpiprazole Impurity 73 CAS 2138169-93-2

Description

Under current pharmacopoeial and regulatory frameworks, quality-control requirements for this class of reference material explicitly involve the control of targets including Brexpiprazole Impurity 73.

CATO supplies Brexpiprazole Impurity 73 (CAS 2138169-93-2), a pharmacopoeial impurity reference standard (molecular formula C41H47N5O2S2, MW 705.97 g/mol) used for the identification and quantification of trace impurities in APIs.

Brexpiprazole Impurity 73 (C41H47N5O2S2) contains a nitrogen-containing heterocyclic scaffold, an amide group, a sulfone group, a hydroxyl group, an ether linkage. It is notably hygroscopic, the carboxyl group imparts weak acidity; these physicochemical properties determine the optimal preparation and storage of its standard solutions. 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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