Vonoprazan Fumarate Impurity 60 CAS CATO-C4X-102060

Description

The occurrence of Vonoprazan Fumarate Impurity 60 is closely related to a nitrogen-containing heterocyclic scaffold, a nitrile group, fluorine/chlorine substitution in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.

Vonoprazan Fumarate Impurity 60 (CAS CATO-C4X-102060) is a certified pharmaceutical impurity reference standard with the molecular formula C11H6ClFN2 and a molecular weight of 220.63 g/mol.

The molecular framework of Vonoprazan Fumarate Impurity 60 (C11H6ClFN2) is characterized by a nitrogen-containing heterocyclic scaffold, a nitrile group, fluorine/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 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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