Naphazoline Impurity 2 (Di HCl) ist das Dihydrochlorid-Salz eines Verunreinigungsprofils eines Imidazolin-Vasokonstriktors, formal beschrieben durch die Formel C14H17N3.2HCl und eine Molekülmasse von 227.31 2 36.46 g/mol. In der Prozesschemie kann eine solche Spezies aus unvollständiger Cyclisierung, Seitenkettenumlagerung oder aus der Salzbildung während der Herstellung von Naphazolin-Vorstufen entstehen. Der protonierte Zustand verändert chromatographische Retention und Ionisierung, sodass eine orthogonale Charakterisierung mittels LC-MS/MS, hochauflösender MS und gegebenenfalls Ion-Pair- oder HILIC-Chromatographie erforderlich ist. Der regulatorische Schwerpunkt liegt auf Strukturzuordnung, Spezifikationsfestlegung und Spurenkontrolle, ergänzt durch NMR und Chloridgehaltsbestimmung.
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