Epinastine Impurity 16 CAS 1557-50-2

Description

Compared with other compounds in its class, the molecular weight of 225.29 g/mol gives Epinastine Impurity 16 distinctive chromatographic separation conditions and mass-spectrometry parameter settings.

CATO supplies Epinastine Impurity 16 (CAS 1557-50-2), a pharmacopoeial impurity reference standard (molecular formula C15H15NO, MW 225.29 g/mol) used for the identification and quantification of trace impurities in APIs.

Epinastine Impurity 16 (C15H15NO) contains a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage. 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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