Biapenem impurity 16 CAS CATO-C4X-227316

Description

The occurrence of Biapenem impurity 16 is closely related to a flavonoid core, an amide group, a sulfone group, a hydroxyl group, an ether linkage in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.

CATO supplies Biapenem impurity 16 (CAS CATO-C4X-227316), a pharmacopoeial impurity reference standard (molecular formula C15H19N3O6S, MW 369.39 g/mol) used for the identification and quantification of trace impurities in APIs.

Based on its molecular formula C15H19N3O6S, Biapenem impurity 16 contains a flavonoid core, an amide group, a sulfone group, a hydroxyl group, an ether linkage; these features give the compound characteristic absorption bands in UV spectroscopy. The molecular weight of 369.39 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.

As a certified reference material (CRM), Biapenem impurity 16 meets the metrological traceability requirements of ISO/IEC 17025 laboratories. Batch-to-batch consistency is monitored via control charts to guarantee comparable assigned values across lots.

Physical & Chemical Properties

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