Sofosbuvir Impurity 99 (CAS 2095880-39-8) | também conhecida como Sofosbuvir BDA Fluoro cinnamoyl ou 1-[(2R)-5 | 6-dimetoxil-5 | 6-dimetil-1 | 4-dioxan-2-il]-3-etoxi-2-fluoro-2-metil-3-oxopropil (2E)-3-fenilprop-2-enoato | é uma impureza estruturalmente definida com grupos fluoro | cinnamoil e dioxano que pode influenciar o perfil farmacotécnico do princípio ativo. Comercializada com pureza de 99 | sua caracterização exige técnicas analíticas robustas como HPLC com detecção UV | LC-MS para identificação de massa molecular e NMR para confirmação estrutural. Estudos de estabilidade | limiares de especificação e investigação de vias sintéticas são essenciais para avaliar seu impacto na qualidade | estabilidade e segurança do lote final.
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