Impureza Relacionada à Moxifloxacina G (CAS 1346603-25-5) é um isômero estereoespecífico | identificado como Moxifloxacin HCl (R | R)-Isomer | que aparece como impureza de síntese no cloridrato de moxifloxacina. Esta impureza apresenta configuração (4aR | 7aR) e propriedades fisicoquímicas semelhantes ao composto principal | exigindo técnicas analíticas altamente seletivas para detecção e quantificação | por exemplo cromatografia líquida com coluna quiral | LC-MS e RMN. O controle de qualidade deve monitorar o perfil de impurezas conforme diretrizes ICH | definindo limites de aceitação e medidas de mitigação no processo para assegurar pureza e conformidade regulatória.
Referências
Kumar, Y. Ravindra., et al. “Structural Identification and Characterization of Impurities in Moxifloxacin.†Journal of Pharmaceutical and Biomedical Analysis, vol. 34, no. 5, Mar. 2004, pp. 1125–29, https://doi.org/10.1016/j.jpba.2003.11.012. Barman Balfour, Julia A., and Harriet M. Lamb. “Moxifloxacin.†Drugs, vol. 59, no. 1, Jan. 2000, pp. 115–39, https://doi.org/10.2165/00003495-200059010-00010.
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