Enalapril EP Impurity A (CAS 76420-74-1) | identificado como el isómero (R | S | S) o Enalapril HCl (1R)-Isomer | es una impureza de síntesis crítica que requiere monitorización en materia prima y lotes intermedios. Presenta características estereoquímicas que pueden influir en la pureza óptica y en el perfil analítico del principio activo. Su identificación y cuantificación se realizan típicamente por HPLC con detección UV | con confirmación estructural por LC-MS y RMN. El control de esta impureza forma parte de las pruebas de liberación y se emplea para verificar cumplimiento con especificaciones EP y optimizar procesos de fabricación.
Referencias
Todd, Peter A., and Karen L. Goa. “Enalapril.†Drugs, vol. 43, no. 3, Mar. 1992, pp. 346–81, https://doi.org/10.2165/00003495-199243030-00005. ?Davies, Richard O., et al. “Enalapril Worldwide Experience.†The American Journal of Medicine, vol. 77, no. 2, Aug. 1984, pp. 23–35, https://doi.org/10.1016/s0002-9343(84)80055-8.
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