Sofosbuvir Impurity 102 es una impureza relacionada con el proceso de síntesis de Sofosbuvir que exige identificación y control riguroso en el desarrollo farmacéutico. Su perfil analítico se define mediante técnicas avanzadas como HPLC-MS | RMN y espectrometría de masas para cuantificación y elucidación estructural. La evaluación incluye estudios de estabilidad | degradación forzada y determinación de límites de aceptación conforme a las guías ICH aplicables | además de validación de los métodos analíticos. El control de esta impureza en fases de síntesis y purificación es crítico para asegurar la calidad del producto y mitigar riesgos de seguridad y eficacia.
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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]")
