Sofosbuvir Impurity 23 (CAS 2041584-99-8) | 1-[(2R)-2-deoxi-2-fluoro-2-metil-alfa-D-erythro-pentofuranosil]-2 | 4(1H | 3H)-pirimidinediona | caracteriza-se por um núcleo nucleosídico fluorado com centro estereogênico 2R que pode originar-se como subproduto de síntese ou por degradação térmica/química do precursor | afetando o perfil de impurezas do lote. Sua identificação e quantificação dependem de metodologias analíticas robustas como HPLC/UHPLC acoplada a LC-MS e confirmação por 1H/13C NMR. Considerada um atributo crítico de qualidade | exige estratégias de controle em processo e purificação | além de métodos validados para monitoramento conforme diretrizes regulatórias ICH.
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