Nafamostat impurity 126 CAS CATO-C4X-1332126

Description

Under current pharmacopoeial and regulatory frameworks, quality-control requirements for this class of reference material explicitly involve the control of targets including Nafamostat impurity 126.

As a process- or degradation-related impurity, Nafamostat impurity 126 (CAS CATO-C4X-1332126, C13H12N2O2) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Nafamostat impurity 126 (C13H12N2O2) contains a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage. It is notably hygroscopic, its high carbon-to-hydrogen ratio confers good lipid solubility, the carboxyl group imparts weak acidity; these physicochemical properties determine the optimal preparation and storage of its standard solutions. 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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