Ezetimibe Impurity 80 CAS CATO-C4X-109880

Description

Compared with other compounds in its class, the molecular weight of 716.96 g/mol gives Ezetimibe Impurity 80 distinctive chromatographic separation conditions and mass-spectrometry parameter settings.

CATO supplies Ezetimibe Impurity 80 (CAS CATO-C4X-109880), a pharmacopoeial impurity reference standard (molecular formula C39H46F2N2O5Si2, MW 716.96 g/mol) used for the identification and quantification of trace impurities in APIs.

Ezetimibe Impurity 80 (C39H46F2N2O5Si2) contains a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage, fluorine substitution. It is notably hygroscopic, halogen substitution raises its density and boiling point, 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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