Ampicillin Impurity 55 CAS CATO-C4X-144355

Description

Compared with other compounds in its class, the molecular weight of 1415.63 g/mol gives Ampicillin Impurity 55 distinctive chromatographic separation conditions and mass-spectrometry parameter settings.

CATO supplies Ampicillin Impurity 55 (CAS CATO-C4X-144355), a pharmacopoeial impurity reference standard (molecular formula C64H78N12O17S4, MW 1415.63 g/mol) used for the identification and quantification of trace impurities in APIs.

The molecular framework of Ampicillin Impurity 55 (C64H78N12O17S4) is characterized by a nitrogen-containing heterocyclic scaffold, an amide group, a sulfone group, a hydroxyl group, an ether linkage. In reversed-phase chromatography, its retention is governed primarily by the protonation state of its nitrogen-containing groups, which provides a practical basis for HPLC-UV/DAD or LC-MS method development. 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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