Impureza Bupropion 2-Oxime (CAS 56472-71-0) é uma impureza conhecida no perfil analítico de Bupropion que resulta de oximação do grupo cetona ou de vias de degradação durante síntese e armazenagem. Apresenta propriedades fisicoquímicas que podem afetar pureza e estabilidade do lote; por isso é monitorada por HPLC com detecção UV e confirmada por espectrometria de massa e RMN. Testes de estresse e validação de método definem limites aceitáveis e condições de processo para minimizar sua formação. A documentação regulatória requer identificação | quantificação e avaliação toxicológica da impureza.
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