Vortioxetine Impurity N1 CAS CATO-C1202544

Description

Under current pharmacopoeial and regulatory frameworks, quality-control requirements for this class of reference material explicitly involve the control of targets including Vortioxetine Impurity N1.

CATO supplies Vortioxetine Impurity N1 (CAS CATO-C1202544), a pharmacopoeial impurity reference standard (molecular formula C17H20N2S, MW 284.42 g/mol) used for the identification and quantification of trace impurities in APIs.

Structurally, Vortioxetine Impurity N1 (C17H20N2S) contains a nitrogen-containing heterocyclic scaffold, a nitrile group, sulfur-containing functionality. The molecule exhibits a degree of unsaturation (DBE) of 9.0, corresponding to approximately 9 ring(s) or double-bond equivalent(s). With a molecular weight of 284.42 g/mol, it falls into the medium-molecular-weight range. 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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