Sugammadex Impurity N14 CAS 53784-83-1

Description

The occurrence of Sugammadex Impurity N14 is closely related to a carboxylic acid group, a hydroxyl group, an ether linkage, bromine substitution, a polycyclic aromatic system in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.

CATO supplies Sugammadex Impurity N14 (CAS 53784-83-1), a pharmacopoeial impurity reference standard (molecular formula C42H63Br7O28, MW 1575.26 g/mol) used for the identification and quantification of trace impurities in APIs.

Sugammadex Impurity N14 (C42H63Br7O28) contains a carboxylic acid group, a hydroxyl group, an ether linkage, bromine substitution, a polycyclic aromatic system. 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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