Esketamine Impurity 7 CAS CATO-C4X-19047

Description

The occurrence of Esketamine Impurity 7 is closely related to a hydroxyl group, an ether linkage, chlorine/bromine substitution, an aromatic ring system in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.

CATO supplies Esketamine Impurity 7 (CAS CATO-C4X-19047), a pharmacopoeial impurity reference standard (molecular formula C12H11Br2ClO, MW 366.48 g/mol) used for the identification and quantification of trace impurities in APIs.

Structurally, Esketamine Impurity 7 (C12H11Br2ClO) contains a hydroxyl group, an ether linkage, chlorine/bromine substitution, an aromatic ring system. 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 366.48 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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