Impureza N-Nitroso Levetiracetam é uma nitrosamina potencialmente genotóxica detectada como impureza relacionada em lotes de levetiracetam. Apresenta estrutura N-nitrosada do análogo amínico e é identificada por LC-MS/MS e GC-MS após derivatização; métodos analíticos devem ser validados para sensibilidade em níveis de ng/g. A formação pode ocorrer por reação de nitritos com aminas secundárias durante síntese | purificação ou armazenamento. Estratégias de controle incluem otimização de pH | eliminação de fontes de nitrito | uso de reagentes livres de nitrosantes e monitoramento contínuo. Avaliação de estabilidade | estabelecimento de limites de especificação e medidas de mitigação são essenciais para atender a requisitos regulatórios sobre nitrosaminas.
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