Phenylephrine Impurity 14 (CAS 2514691-61-1) é uma impureza associada ao processo de síntese da fenilefrina | de importância crítica para o controle analítico e regulatório do API. Apresenta perfil cromatográfico e assinaturas espectrais que exigem identificação por HPLC acoplada a espectrometria de massas | complementada por RMN para confirmação estrutural. Pode originar-se por vias de reação secundária | impurezas de partida ou degradação durante armazenamento | impactando pureza e estabilidade. A quantificação precisa | estabelecimento de limites conforme guias ICH e validação robusta de métodos analíticos são essenciais para mitigação de risco e garantia de conformidade.
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