Hydantoin Impurity 13 CAS CATO-C4X-214613

Description

Compared with other compounds in its class, the molecular weight of 128.17 g/mol gives Hydantoin Impurity 13 distinctive chromatographic separation conditions and mass-spectrometry parameter settings.

CATO supplies Hydantoin Impurity 13 (CAS CATO-C4X-214613), a pharmacopoeial impurity reference standard (molecular formula C6H12N2O, MW 128.17 g/mol) used for the identification and quantification of trace impurities in APIs.

Based on its molecular formula C6H12N2O, Hydantoin Impurity 13 contains an amide group, a hydroxyl group, an ether linkage; these features give the compound characteristic functional-group stretching vibrations in infrared spectroscopy. The molecular weight of 128.17 g/mol is directly relevant to the identification of the molecular ion in mass spectrometry. Nitrogen-containing functional groups confer excellent ionization efficiency in positive-ion electrospray (ESI) mode, making the compound well suited to LC-MS/MS analysis.

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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