Acyclovir Impurity 3 é uma impureza estrutural identificada no perfil de estabilidade do princípio ativo aciclovir | definida como N-(9-((2-((2-acetamido-6-oxo-1 | 6-dihidro-7H-purin-7-yl)methoxy)ethoxy)methyl)-6-oxo-6 | 9-dihydro-1H-purin-2-yl)acetamide. Esta impureza apresenta alta polaridade e é geralmente detectada em níveis traço por HPLC e LC-MS | com identidade confirmada por RMN e análise espectrométrica. A monitorização de Acyclovir Impurity 3 é crítica para o controle de qualidade e estabelecimento de limites conforme diretrizes ICH | permitindo avaliação de origem por degradação ou subprodutos de processo e suporte à validação analítica para garantir conformidade das especificações.
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