Bicalutamide EP Impurity K | también referida como Bicalutamide JP Related substance K | es una impureza identificada en el perfil de Bicalutamide que requiere caracterización rigurosa para control de calidad farmacéutico. Su evaluación incluye identificación estructural mediante LC-MS y RMN | cuantificación por HPLC validado y determinación de límites de aceptación en concordancia con guías ICH. El monitoreo de esta impureza es crítico en estudios de estabilidad | liberación de lote y validación de procesos para garantizar cumplimiento regulatorio y seguridad del producto. Los datos analíticos permiten establecer especificaciones | investigar fuentes de formación y optimizar la eliminación en etapas de síntesis y purificación.
Referencias
Neyman, A., Fuqua, J. S., & Eugster, E. A. (2019). Bicalutamide as an Androgen Blocker With Secondary Effect of Promoting Feminization in Male-to-Female Transgender Adolescents. Journal of Adolescent Health, 64(4), 544–546. https://doi.org/10.1016/j.jadohealth.2018.10.296
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