Rocuronium impurity 65 CAS CATO-C4X-124265

Description

Compared with other compounds in its class, the molecular weight of 304.42 g/mol gives Rocuronium impurity 65 distinctive chromatographic separation conditions and mass-spectrometry parameter settings.

CATO supplies Rocuronium impurity 65 (CAS CATO-C4X-124265), a pharmacopoeial impurity reference standard (molecular formula C19H28O3, MW 304.42 g/mol) used for the identification and quantification of trace impurities in APIs.

Structurally, Rocuronium impurity 65 (C19H28O3) contains a steroid core, a hydroxyl group, an ether linkage. The molecule exhibits a degree of unsaturation (DBE) of 6.0, corresponding to approximately 6 ring(s) or double-bond equivalent(s). With a molecular weight of 304.42 g/mol, it falls into the moderately-high-molecular-weight range. The high carbon-to-hydrogen ratio imparts good lipophilicity, allowing liquid-liquid extraction with non-polar solvents such as n-hexane or ethyl acetate.

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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