Nerandomilast impurity 4 CAS CATO-C4X-34734

Description

Compared with other compounds in its class, the molecular weight of 225.67 g/mol gives Nerandomilast impurity 4 distinctive chromatographic separation conditions and mass-spectrometry parameter settings.

Nerandomilast impurity 4 (CAS CATO-C4X-34734) is a certified pharmaceutical impurity reference standard with the molecular formula C10H12ClN3O and a molecular weight of 225.67 g/mol.

Nerandomilast impurity 4 (C10H12ClN3O) contains a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage, chlorine substitution. Halogen substitution raises its density and boiling point, its high carbon-to-hydrogen ratio confers good lipid solubility; these physicochemical properties determine the optimal preparation and storage of its standard solutions. 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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