Naphazoline EP Impurity A (CAS 36321-43-4) | conocida también como Naphthylacetylethylenediamine o 1-Naphthaleneacetamide | es una impureza derivada del núcleo naftalénico presente en síntesis de naphazoline. Su estructura acilada con cadena aminoalquila confiere absorción UV significativa y polaridad intermedia | lo que facilita su detección por HPLC-UV y confirmación mediante LC-MS y RMN. Desde el punto de vista de control de calidad esta impureza puede afectar pureza | perfil de impurezas y estabilidad del principio activo por lo que su cuantificación y límites analíticos según especificaciones farmacéuticas son esenciales para cumplimiento regulatorio y seguridad del producto.
Referencias
“Development and Validation of a Capillary Electrophoretic Method for the Determination of Degradation Product in Naphazoline HCl Bulk Drug Substance.” Journal of Liquid Chromatography & Related Technologies, 2021, www.tandfonline.com/doi/abs/10.1080/10826079808003408.?QUAN, LIN, and HUA HE. “Treatment with Olopatadine and Naphazoline Hydrochloride Reduces Allergic Conjunctivitis in Mice through Alterations in Inflammation, NGF and VEGF.” Molecular Medicine Reports, vol. 13, no. 4, Feb. 2016, pp.
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