Impureza Bupropiona 14 (CAS 92821-91-5) é um subproduto orgânico detectado em etapas intermediárias e no produto final da síntese de bupropiona | com perfil cromatográfico e espectral distintivo. Apresenta propriedades físico-químicas que podem alterar estabilidade e perfil farmacotóxico do lote | exigindo investigação de origem por vias de reação secundárias ou degradativas. A identificação e quantificação são realizadas por HPLC com padrão de referência e confirmada por LC-MS/MS e RMN para elucidação estrutural. Estudos de qualificação | avaliação de genotoxicidade e estabelecimento de limites de especificação devem seguir guidelines ICH aplicáveis | integrando controles de processo e validação analítica robusta.
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