A impureza associada à Fenilefrina Cloridrato (CAS 61-76-7) representa um risco crítico ao perfil de qualidade do ativo | incluindo impurezas relacionadas sintéticas e produtos de degradação formados por oxidação ou descarboxilação. O perfil de impurezas é monitorado por HPLC com detecção UV e confirmado por LC-MS para identificação estrutural e quantificação abaixo dos limites de especificação. Controle de processo e condições de armazenamento minimizam a formação de degradantes | enquanto testes de pureza | ensaios de massa e validação de métodos asseguram conformidade regulatória e segurança do produto final. Documentação técnica detalhada suporta liberação de lote e investigação de desvios.
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