Impureza Bicalutamide JP Related substance O (CAS 339530-91-5) es una sustancia relacionada identificada en el perfil de impurezas de bicalutamida cuya caracterización requiere métodos analíticos robustos; su detección se realiza típicamente por HPLC-UV con confirmación por LC-MS y RMN para establecer estructura y masa exacta. Es recomendable validar métodos cuantitativos conforme a criterios de precisión | exactitud | linealidad y límites de detección | y ejecutar estudios de estrés ácido | básico | oxidativo y fotolítico para evaluar su formación. La evaluación toxicológica | la definición de límites en especificación de lote y la trazabilidad mediante estándares de referencia son esenciales para cumplir requisitos regulatorios ICH y garantizar control de calidad consistente.
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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