Anastrozole EP Impurity E (CAS 120511-88-8) es un contaminante crítico monitorizado en el control de calidad de materias primas farmacéuticas | caracterizado por su perfil analítico y potencial impacto sobre la pureza del lote. Presenta propiedades fisicoquímicas que requieren técnicas de cuantificación sensibles | incluyendo cromatografía líquida de alta resolución y espectrometría de masas para identificación y cuantificación trazable. Su presencia puede influir en la estabilidad del principio activo y en los criterios de aceptación del producto | por lo que se recomiendan límites especificados | estudios de degradación forzados y validación de métodos analíticos. El control robusto y la documentación trazable son esenciales para mitigarlo.
Referencias
Gangadhara, Sharath, and Gianfilippo Bertelli. “Long-Term Efficacy and Safety of Anastrozole for Adjuvant Treatment of Early Breast Cancer in Postmenopausal Women.†Therapeutics and Clinical Risk Management, vol. 5, 2009, pp. 291–300, www.ncbi.nlm.nih.gov/pmc/articles/PMC2690973/.
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