Atorvastatin FXA Impurity (Free Base) es una impureza relacionada con el proceso de síntesis y degradación de atorvastatina en su forma de base libre. Se caracteriza por mayor lipofilia que la sal | retención tardía en HPLC reverso y patrones confirmables por LC-MS y RMN. Su aparición puede deberse a reacciones incompletas de protección/desprotección o a condiciones alcalinas en purificación. La cuantificación exige métodos indicativos de estabilidad con límites especificados en especificaciones de calidad | uso de estándares de referencia y técnicas de muestreo controladas. Estrategias de reducción incluyen optimización de etapas sintéticas | condiciones de limpieza y controles de pH en proceso.
Referencias
“Statin Therapy: Review of Safety and Potential Side Effects.” Acta Cardiologica Sinica, vol. 32, no. 6, Taiwan Society of Cardiology, 2016, pp. 631–39, https://doi.org/10.6515/ACS20160611A.
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