Sugammadex Impurity 61 CAS 53784-84-2

Description

Compared with other compounds in its class, the molecular weight of 1800.30 g/mol gives Sugammadex Impurity 61 distinctive chromatographic separation conditions and mass-spectrometry parameter settings.

As a process- or degradation-related impurity, Sugammadex Impurity 61 (CAS 53784-84-2, C48H72Br8O32) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Sugammadex Impurity 61 (C48H72Br8O32) 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 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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