Sivelestat sodium impurity 45 CAS CATO-C4X-212345

Description

The occurrence of Sivelestat sodium impurity 45 is closely related to a flavonoid core, an amide group, a hydroxyl group, an ether linkage in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.

CATO supplies Sivelestat sodium impurity 45 (CAS CATO-C4X-212345), a pharmacopoeial impurity reference standard (molecular formula C15H12N2O4, MW 284.27 g/mol) used for the identification and quantification of trace impurities in APIs.

Sivelestat sodium impurity 45 (C15H12N2O4) contains a flavonoid core, an amide 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 presence of an aromatic ring or conjugated system gives the compound characteristic absorption bands in the UV-Vis region, making it well suited to UV or diode-array detection (DAD).

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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