Naphazoline EP Impurity D (CAS 22126-67-6) es una impureza estructuralmente relacionada detectada en el proceso de síntesis y formulación de naphazoline según la Farmacopea Europea. Esta impureza se caracteriza por su perfil cromatográfico único y puntos de retención específicos en HPLC | absorción UV y masas moleculares identificables por LC-MS. Su identificación y cuantificación son críticas para garantizar conformidad con especificaciones de pureza y seguridad. Los métodos analíticos validados incluyen HPLC con detector UV y técnicas de espectrometría de masas para confirmar identidad | mientras que estudios de degradación y control de proceso ayudan a minimizar su formación en etapas de fabricación.
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.Wall, G. Michael. “Naphazoline Hydrochloride.†Analytical Profiles of Drug Substances and Excipients, 1992, pp. 307–44, https://doi.org/10.1016/s0099-5428(08)60396-2.
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