Nifuratel Impurity 18 CAS CATO-C4X-127218

Description

Under current pharmacopoeial and regulatory frameworks, quality-control requirements for this class of reference material explicitly involve the control of targets including Nifuratel Impurity 18.

CATO supplies Nifuratel Impurity 18 (CAS CATO-C4X-127218), a pharmacopoeial impurity reference standard (molecular formula C9H9NO7, MW 243.17 g/mol) used for the identification and quantification of trace impurities in APIs.

Based on its molecular formula C9H9NO7, Nifuratel Impurity 18 contains an amino-acid-derived structure, an amide group, a hydroxyl group, an ether linkage; these features give the compound characteristic absorption bands in UV spectroscopy. The molecular weight of 243.17 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.

As a certified reference material (CRM), Nifuratel Impurity 18 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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