Sofosbuvir Impurity 102 é uma impureza relacionada ao ingrediente farmacêutico ativo Sofosbuvir | relevante para controle de qualidade e investigação de perfil de impurezas | detectada tipicamente em níveis traço durante síntese e estudos de estabilidade. Caracteriza-se por propriedades cromatográficas específicas | sendo quantificada por HPLC e confirmada por LC-MS e NMR para elucidação estrutural. A avaliação inclui limiares de visibilidade | desenvolvimento de métodos validados e estudos de formação em processos de fabricação e degradação forçada. A gestão dessa impureza é crítica para conformidade regulatória segundo diretrizes ICH | mitigação de riscos e estabelecimento de especificações analíticas robustas.
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