Donepezil Impurity 17 CAS 127399-78-4

Description

Compared with other compounds in its class, the molecular weight of 178.18 g/mol gives Donepezil Impurity 17 distinctive chromatographic separation conditions and mass-spectrometry parameter settings.

CATO supplies Donepezil Impurity 17 (CAS 127399-78-4), a pharmacopoeial impurity reference standard (molecular formula C10H10O3, MW 178.18 g/mol) used for the identification and quantification of trace impurities in APIs.

Donepezil Impurity 17 (C10H10O3) contains a carboxylic acid group, a hydroxyl group, an ether linkage, an aromatic ring system. It is notably hygroscopic, its high carbon-to-hydrogen ratio confers good lipid solubility, 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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