Rocuronium Impurity 61 CAS CATO-C4X-124261

Description

The occurrence of Rocuronium Impurity 61 is closely related to a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage, bromine substitution in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.

CATO supplies Rocuronium Impurity 61 (CAS CATO-C4X-124261), a pharmacopoeial impurity reference standard (molecular formula C32H53N2O4Br, MW 609.69 g/mol) used for the identification and quantification of trace impurities in APIs.

Structurally, Rocuronium Impurity 61 (C32H53N2O4Br) contains a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage, bromine substitution. The molecule exhibits a degree of unsaturation (DBE) of 7.0, corresponding to approximately 7 ring(s) or double-bond equivalent(s). With a molecular weight of 609.69 g/mol, it falls into the high-molecular-weight range. Halogen substitution (F/Cl/Br/I) produces a distinctive isotope pattern in mass spectrometry, a valuable aid for qualitative confirmation.

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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