Amoxicillin EP Impurity F (CAS 126247-63-0) | também identificada como Amoxicillin Related Compound F | é uma impureza conhecida no perfil de qualidade da amoxicilina que requer monitoramento rigoroso. Quimicamente definida na Farmacopeia Europeia | sua presença pode indicar vias de degradação ou subprodutos na síntese. Técnicas analíticas validadas como HPLC com detecção UV e espectrometria de massas são empregadas para quantificação e identificação estruturada. O controle de limites | estudos de estabilidade forçados e otimização do processo de fabricação minimizam sua formação. Documentação compatível com boas práticas regulamentares assegura avaliação de risco | aceitabilidade e implementação de medidas de mitigação.
Referências
Valvo, L., et al. Development of a Simple Liquid Chromatographic Method with UV and Mass Spectrometric Detection for the Separation of Substances Related to Amoxicillin Sodium.â€Â Journal of Chromatography A, vol. 797, no. 1-2, Feb. 1998, pp. 311–16, https://doi.org/10.1016/s0021-9673(97)00952-7 Zhu, Yongxin, et al. Evaluation of Liquid Chromatography Methods for the Separation of Ampicillin and Its Related Substances.†Journal of Pharmaceutical and Biomedical Analysis, vol. 14, no. 5, Mar. 1996
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