Impureza de cetona aromática com identificação CAS 93-55-0 (Propiofenona; 3-Phenyl-3-propanone; Ethyl Phenyl Ketone) | caracterizada por ponto de ebulição elevado e solubilidade limitada em água mas boa solubilidade em solventes orgânicos | relevante no perfil de pureza do Bupropion. Detectável e quantificável por técnicas analíticas como GC | HPLC acoplado a MS | RMN e espectroscopia IV | esta impureza pode resultar de reações secundárias ou condições de processamento subóptimas. Seu controle é crítico para cumprir limites de impurezas relacionados a ICH Q3A/Q3B | exigindo otimização de reação | etapas de purificação e análises de estabilidade para minimizar impacto sobre qualidade e segurança do produto final.
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