Norfloxacin EP Impurity K (CAS 70459-07-3) | também designado Norfloxacin Related Compound K ou 6-fluoro-1-methyl-4-oxo-7-piperazin-1-ylquinoline-3-carboxylic acid | é uma impureza isolada no perfil de pureza do princípio ativo norfloxacina. Apresenta-se como análogo N-metil formado por vias de síntese e degradação | sendo monitorada por HPLC/UPLC com detecção UV e confirmada por LC-MS e RMN para estabelecimento de identidade e pureza. A caracterização destas impurezas é crítica para controle de qualidade | definição de limites de especificação | estudos de estabilidade e validação de métodos | com padrões de referência certificados para garantir conformidade farmacopéica.
Referências
Nageswara Rao, R., and V. Nagaraju. “Separation and Determination of Synthetic Impurities of Norfloxacin by Reversed-Phase High Performance Liquid Chromatography.†Journal of Pharmaceutical and Biomedical Analysis, vol. 34, no. 5, Mar. 2004, pp. 1049–56, https://doi.org/10.1016/j.jpba.2003.11.009.?
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