Ketoconazole Impurity 16 CAS 2234-16-4

Description

The occurrence of Ketoconazole Impurity 16 is closely related to a hydroxyl group, an ether linkage, chlorine substitution, an aromatic ring system in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.

Ketoconazole Impurity 16 (CAS 2234-16-4) is a certified pharmaceutical impurity reference standard with the molecular formula C8H6Cl2O and a molecular weight of 189.04 g/mol.

The molecular framework of Ketoconazole Impurity 16 (C8H6Cl2O) is characterized by a hydroxyl group, an ether linkage, chlorine substitution, an aromatic ring system. In reversed-phase chromatography, its retention is governed primarily by the polarity and ionization state of its functional groups, 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).

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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