Relebactam Impurity 66 CAS CATO-C4X-214466

Description

The occurrence of Relebactam Impurity 66 is closely related to an amide group, a sulfone group, a carboxylic acid group, a hydroxyl group, an ether linkage in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.

As a process- or degradation-related impurity, Relebactam Impurity 66 (CAS CATO-C4X-214466, C16H29N4O7SC16H36N) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Owing to an amide group, a sulfone group, a carboxylic acid group, a hydroxyl group, an ether linkage, Relebactam Impurity 66 is typically white to pale yellow amorphous powder. Its solid-state physicochemical attributes — including a molecular weight of 663.96 g/mol — guide the selection of appropriate sample preparation and analytical techniques. 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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