Impureza Norepinefrina EP Impureza A (CAS 51-43-4) | también referida como Noradrenalina EP Impureza A o L-(-)-Epinefrina | es un contaminante crítico en materias primas relacionadas con adrenalina. Presenta polaridad y grupos catecol que afectan retención en HPLC y requieren condiciones de fase inversa con protección contra oxidación. Su identificación se realiza por HPLC-UV acoplado a espectrometría de masas y confirmación por RMN. Su presencia influye en cumplimiento de especificaciones | potencia y estabilidad del lote; por tanto se definen límites de aceptación | perfiles de degradación y estrategias de control analítico como validación de método | pruebas de proceso y almacenamiento bajo condiciones anóxicas para minimizar formación.
Referencias
Lavanya, N., and C. Sekar. “Electrochemical Sensor for Simultaneous Determination of Epinephrine and Norepinephrine Based on Cetyltrimethylammonium Bromide Assisted SnO 2 Nanoparticles.†Journal of Electroanalytical Chemistry, vol. 801, Sept. 2017, pp. 503–10, https://doi.org/10.1016/j.jelechem.2017.08.018. ‌Wieruszewski, Erin D., et al. “Predictors of Dysrhythmias with Norepinephrine Use in Septic Shock.†Journal of Critical Care, vol. 61, Feb. 2021, pp. 133–37, https://doi.org/10.1016/j.jcrc.2020.10.023. ‌
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