Sofosbuvir Impurity 45 (CAS 1337529-56-2) | denominado Propan-2-yl (2S)-2-[[(2 | 3 | 4 | 5 | 6-pentafluorophenoxy)-phenoxyphosphoryl]amino]propanoate | es una impureza relacionada con el proceso de síntesis de Sofosbuvir que exige identificación | cuantificación y control en las especificaciones del API. Su detección se realiza típicamente por HPLC acoplado a detectores UV y LC-MS para confirmación de masa y por RMN para elucidación estructural. Se considera relevante en estudios de calidad y estabilidad debido a rutas de formación por reacciones secundarias o pasos de acoplamiento incompletos. La caracterización y el establecimiento de límites analíticos conformes a ICH son esenciales para garantizar pureza | seguridad y cumplimiento regulatorio.
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![Sofosbuvir 5'-Desphosphate 3'-O-[(S)-Phosphate]](https://veeprho.com/wp-content/uploads/2022/07/Sofosbuvir-5-Desphosphate-3-O-5BS-Phosphate5D.png "Sofosbuvir 5'-Desphosphate 3'-O-[(S)-Phosphate]")
