Phenylephrine Impurity 3 (HCl Salt) é uma impureza relacionada ao processo de síntese do fármaco que se apresenta como sal hidrogeno-clorídrico e requer monitoramento rigoroso no controle de qualidade. Caracteriza-se por perfil cromatográfico distinto | massa molecular e fragmentação por espectrometria de massas | e propriedades de solubilidade e estabilidade diferentes do princípio ativo | exigindo métodos analíticos validados por HPLC | LC-MS e NMR para identificação e quantificação. A presença dessa impureza pode afetar o rendimento de purificação | o perfil de degradação e a aceitabilidade regulatória | tornando críticas as especificações | limites de aceitação e estratégias de redução no processo.
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