La impureza Atorvastatin Impurity 157, conocida también como 2-hidroxi-atorvastatina sal disódica, es un degradado y metabolito potencial que requiere monitorización en el control de calidad del principio activo atorvastatina. Se genera por reacciones de hidroxilación y procesos oxidativos durante síntesis y almacenamiento, y su forma salina modifica solubilidad y comportamiento cromatográfico. Su identificación y cuantificación se realiza mediante HPLC con detección UV y confirmación por LC-MS y RMN para soportar la especificación. La evaluación de su perfil toxicológico y los límites de aceptación se determinan según guías regulatorias ICH, siendo crítico su seguimiento en estudios de estabilidad y desarrollo analítico.
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