Norfloxacin EP-Impurität E, auch als Norfloxacin-HCl-7-Chlor-Analogon und Norfloxacin Related Compound E bezeichnet, ist das Hydrochlorid einer Fluorchinolon-Prozessverunreinigung mit Halogenmuster-Isomerie innerhalb der Norfloxacin-Synthesefamilie. CAS 75001-78-4; Formel C16H18ClN3O3 . HCl; Molekulargewicht 372.25 für das Salz, entsprechend 335.79 für die freie Base. Ihr Auftreten ist typischerweise auf verfahrensabhängige Mitführung chlorierter Vorstufen oder späte Substitutionsfehlinkorporation und nicht auf oxidative Abbauprozesse zurückzuführen. Die Charakterisierung erfordert üblicherweise LC-MS/MS, HPLC mit Diodenarraydetektion und, für die Strukturabsicherung, NMR sowie HRMS. Solche Verunreinigungen werden im Rahmen pharmakopöischer und ICH-basierten Impuritätskontrolle bewertet.
References
Mielji, Branislava, et al. “Column High-Performance Liquid Chromatographic Determination of Norfloxacin and Its Main Impurities in Pharmaceuticals.†Journal of AOAC INTERNATIONAL, vol. 91, no. 2, Mar. 2008, pp. 332–38, https://doi.org/10.1093/jaoac/91.2.332 Kaplowitz, Lisa G., et al. “Norfloxacin in the Treatment of Uncomplicated Gonococcal Infections.†The American Journal of Medicine, vol. 82, no. 6, June 1987, pp. 35–39, https://doi.org/10.1016/0002-9343(87)90616-4.?
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