Olaparib Nitroso Impurity 1 (CAS 2742659-74-9) é uma impureza nitroso estruturalmente definida do inibidor de PARP olaparibe, com fórmula molecular C20H18FN5O3 e massa molecular de 395.39 g/mol. A designação indica um motivo de risco do tipo nitrosamina, relevante para a avaliação de impurezas mutagênicas segundo ICH M7 e para estratégias contemporâneas de controle de nitrosaminas. Tais espécies podem surgir por nitrosação de intermediários contendo amina ou por condições de processo nitrosantes. A detecção em níveis traço normalmente exige caracterização ortogonal por LC-MS/MS, espectrometria de massas de alta resolução e, quando a volatilidade permite, GC-MS. A confirmação espectral é indispensável.
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