Impureza relacionada P de Bicalutamida JP es una impureza orgánica identificada durante el desarrollo y control de calidad del principio activo. Se caracteriza por su perfil cromatográfico y espectrométrico y se detecta y cuantifica mediante HPLC con detección UV y confirmación por LC-MS. Su presencia | incluso en niveles traza | requiere límites y criterios de aceptación claros para garantizar la conformidad farmacéutica y minimizar riesgos toxicológicos. El establecimiento de métodos de separación robustos | validación de especificación de impurezas y estudios de forzamiento ayudan a su identificación y eliminación en procesos de síntesis y purificación. Información analítica reproducible es esencial para cumplimiento con JP y normas ICH.
Referencias
Chen, K.-C., Chen, C.-R., Chen, C.-Y., Tzou, K.-Y., Peng, C.-C., & Peng, R. Y. (2020). Bicalutamide Elicits Renal Damage by Causing Mitochondrial Dysfunction via ROS Damage and Upregulation of HIF-1. International Journal of Molecular Sciences, 21(9), 3400. https://doi.org/10.3390/ijms21093400 ‌‌ ‌
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