N-Nitroso Cetirizine EP Impurity A, também denominada N-Nitroso Hydroxyzine EP Impurity A, é uma nitrosamina associada ao núcleo anti-histamínico de piperazina e classificada estruturalmente como impureza potencialmente genotóxica. Com CAS 2005-04-1, fórmula molecular C17H18ClN3O e massa molecular de 315,80 g/mol, a substância reflete a N-nitrosação do precursor amínico correspondente durante a síntese, o armazenamento ou a exposição a agentes nitrosantes. No contexto regulatório, essas espécies são avaliadas segundo ICH M7 devido ao risco mutagênico e carcinogênico. A determinação em níveis traço geralmente requer LC-MS/MS ou LC-MS de alta resolução, com confirmação por GC-MS quando aplicável.
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