Phenytoin Impurity 12 CAS 15427-81-3

Description

Compared with other compounds in its class, the molecular weight of 226.27 g/mol gives Phenytoin Impurity 12 distinctive chromatographic separation conditions and mass-spectrometry parameter settings.

As a process- or degradation-related impurity, Phenytoin Impurity 12 (CAS 15427-81-3, C14H14N2O) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Phenytoin Impurity 12 (C14H14N2O) contains a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage. Its high carbon-to-hydrogen ratio confers good lipid solubility; 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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