Impureza de Epinefrina 18 é um contaminante identificado no perfil de impurezas da epinefrina que requer caracterização técnica e controle analítico rigoroso. Geralmente originada por vias de síntese ou por degradação oxidativa | esta impureza pode afetar a pureza | a estabilidade e a segurança do produto final. A sua detecção e quantificação demandam métodos validados como HPLC com detecção UV e LC-MS para elucidação estrutural | complementados por RMN quando necessário. Estudos de esterilização e estabilidade acelerada ajudam a determinar vias formadoras e limites aceitáveis em conformidade com diretrizes ICH Q3A e Q3B. Procedimentos de purificação e controles durante o processo mitigam a sua presença.
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