Ramelteon Impurity 63 CAS CATO-C4X-262263

Description

Compared with other compounds in its class, the molecular weight of 257.33 g/mol gives Ramelteon Impurity 63 distinctive chromatographic separation conditions and mass-spectrometry parameter settings.

CATO supplies Ramelteon Impurity 63 (CAS CATO-C4X-262263), a pharmacopoeial impurity reference standard (molecular formula C16H19NO2, MW 257.33 g/mol) used for the identification and quantification of trace impurities in APIs.

Based on its molecular formula C16H19NO2, Ramelteon Impurity 63 contains a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage; these features give the compound characteristic absorption bands in UV spectroscopy. The molecular weight of 257.33 g/mol is directly relevant to the identification of the molecular ion in mass spectrometry. 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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