Impureza Dinitroso-metil-piperazina associada à gatifloxacina (CAS 55556-94-0) | também referida como 2-metildinitrosopiperazina ou 2-metil-N | N’-dinitrosopiperazina | é uma impureza nitrosa de interesse analítico e regulatório; devido à presença de grupos nitroso | exige monitorização rigorosa por técnicas sensíveis como HPLC com detecção UV | LC-MS/MS e GC-MS para quantificação e caracterização de traços. Sua identificação e quantificação são essenciais para avaliação de pureza | investigação de vias de degradação e avaliação de risco toxicológico segundo diretrizes ICH. Recomenda-se estabelecer especificações | métodos validados e estratégias de controle de processo para minimizar sua formação e garantir conformidade.
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