Vortioxetine Impurity 45 CAS 2925447-38-5

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 45.

Vortioxetine Impurity 45 (CAS 2925447-38-5) is a certified pharmaceutical impurity reference standard with the molecular formula C18H21N3OS and a molecular weight of 327.44 g/mol.

The molecular framework of Vortioxetine Impurity 45 (C18H21N3OS) is characterized by a steroid core, an amide group, sulfur-containing functionality, a hydroxyl group, an ether linkage. In reversed-phase chromatography, its retention is governed primarily by its high hydrophobicity (logP), which provides a practical basis for HPLC-UV/DAD or LC-MS method development. Nitrogen-containing functional groups confer excellent ionization efficiency in positive-ion electrospray (ESI) mode, making the compound well suited to LC-MS/MS analysis.

Recommended for quantitative analysis by HPLC, GC, LC-MS/MS, or GC-MS as an external calibration standard; it can also be used for spiked-recovery experiments, LOD/LOQ determination, and LC-MS/MS multiple-reaction-monitoring (MRM) calibration.

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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