Impureza relacionada ao cloridrato de amantadina CRS (A0363000 | CAS 665-66-7) descrita por seu perfil químico e impacto na qualidade do padrão de referência. Caracteriza-se por impurezas de síntese e produtos de degradação que afetam pureza | solubilidade e estabilidade. Métodos analíticos validados como HPLC com deteção UV | cromatografia gasosa | espectrometria de massas e RMN são utilizados para identificação e quantificação. Os limites são definidos conforme diretrizes ICH e controle de lote inclui testes de retenção | isolamento e caracterização estrutural para assegurar conformidade. A monitorização sistemática minimiza risco analítico e garante reprodutibilidade dos ensaios de referência.
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