Naphazoline Impurity 2 (Di HCl) es la sal dihidrocloruro asociada al perfil de impurezas de un vasoconstrictor imidazolina, descrita formalmente por la fórmula C14H17N3.2HCl y un peso molecular de 227.31 2 36.46 g/mol. En química de proceso, esta especie puede originarse por ciclización incompleta, reordenamiento de la cadena lateral o arrastre de formación salina durante la manufactura de intermediarios relacionados con nafazolina. Su estado protonado modifica la retención cromatográfica y la ionización, por lo que su caracterización requiere LC-MS/MS, MS de alta resolución y, cuando procede, cromatografía de par iónico o HILIC. La evaluación regulatoria se centra en la asignación estructural, la especificación de impurezas y el control a nivel traza, con apoyo de RMN y determinación de cloruro.
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