Clofazimine Impurity 2 CAS 2158184-11-1

Description

Under current pharmacopoeial and regulatory frameworks, quality-control requirements for this class of reference material explicitly involve the control of targets including Clofazimine Impurity 2.

Clofazimine Impurity 2 (CAS 2158184-11-1) is a certified pharmaceutical impurity reference standard with the molecular formula C27H23ClN4 and a molecular weight of 438.95 g/mol.

The molecular framework of Clofazimine Impurity 2 (C27H23ClN4) is characterized by a nitrogen-containing heterocyclic scaffold, a nitrile group, chlorine substitution. 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. The presence of an aromatic ring or conjugated system gives the compound characteristic absorption bands in the UV-Vis region, making it well suited to UV or diode-array detection (DAD).

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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