Amantadine Impurity 2 (CAS 702-77-2) é uma impureza relacionada que exige análise robusta devido ao potencial impacto na qualidade do API; trata-se tipicamente de um subproduto gerado em etapas de síntese e purificação | com propriedades físico-químicas que podem diferir da amantadina em polaridade | basicidade e comportamento de cristalização. A sua identificação e quantificação são realizadas por HPLC com detector DAD | LC-MS para confirmação de massa e 1H/13C NMR para elucidação estrutural. Estratégias de controle incluem otimização de condições reacionais | purificação cromatográfica e validação analítica para garantir níveis aceitáveis | além de estudos de estabilidade e avaliação toxicológica para conformidade regulatória.
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