N-Nitrosonorfloxacin (CAS 74011-53-3) is the N-nitrosamine derivative of norfloxacin, chemically classified as a potentially genotoxic impurity arising from nitrosation of the secondary amine functionality under acidic or oxidative manufacturing conditions. Its molecular formula is C16H17FN4O4 with a molecular weight of 348.33 g/mol. In regulatory assessment, this class of impurity is treated with heightened concern under ICH M7 due to possible DNA-reactive behavior. Trace-level determination typically requires highly selective LC-MS/MS, often supported by high-resolution mass spectrometry, and, where appropriate, GC-MS after derivatization or enrichment. Structural confirmation may also rely on isotopic pattern analysis and fragment ion mapping.
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