N-Benzyl Epinephrine Impurity (CAS 1095714-91-2) | también conocida como rac Adrenaline Impurity D | es una impureza sintética derivada de la N-bencilación de la epinefrina que puede afectar la pureza y estabilidad farmacéutica. Su perfil analítico requiere técnicas de alta resolución como HPLC con detección UV/ELSD | LC-MS para confirmación de masa y RMN para asignación estructural. Se presta atención a mecanismos de formación durante etapas de protección y desprotección | límites regulatorios y criterios de aceptación según ICH Q3A. La cuantificación | la evaluación de la toxicidad potencial y la disponibilidad de estándares de referencia son clave para el control de calidad y la trazabilidad.
Referencias
«Simons, F. Estelle. R., et al. “Epinephrine Absorption in Adults: Intramuscular versus Subcutaneous Injection.†Journal of Allergy and Clinical Immunology, vol. 108, no. 5, Nov. 2001, pp. 871–73, https://doi.org/10.1067/mai.2001.119409. ?»
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