Impureza Norfloxacina EP Impurity H | também referida como Norfloxacin Related Compound H ou Norfloxacin N-Ethoxycarbonyl Impurity | CAS 105440-01-5 | é uma impureza relacionada identificada em lotes de norfloxacino que resulta de reações de N-etoxicarbonilação durante a síntese. Apresenta comportamento cromatográfico distintivo em HPLC e é detectável por LC-MS e caracterizável por RMN | exigindo monitorização rigorosa em acordo com monografias e limites de processo. A sua identificação e quantificação são críticas para controlo de qualidade | investigação de causas raiz e validação de métodos analíticos. Fornecemos material de referência e dados analíticos para suportar avaliação de pureza | identificação e estudo de degradantes.
Referências
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.?
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