Roxatidine impurity 68 CAS CATO-C4X-121368

Description

Compared with other compounds in its class, the molecular weight of 421.53 g/mol gives Roxatidine impurity 68 distinctive chromatographic separation conditions and mass-spectrometry parameter settings.

CATO supplies Roxatidine impurity 68 (CAS CATO-C4X-121368), a pharmacopoeial impurity reference standard (molecular formula C22H35N3O5, MW 421.53 g/mol) used for the identification and quantification of trace impurities in APIs.

Based on its molecular formula C22H35N3O5, Roxatidine impurity 68 contains a flavonoid core, an amide group, a hydroxyl group, an ether linkage; these features give the compound characteristic absorption bands in UV spectroscopy. The molecular weight of 421.53 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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