Impureza G da Amoxicilina (Amoxicillin EP Impurity G | CAS 188112-75-6) | também referida como Amoxicillin Related Compound G | é um degradante crítico monitorado em matérias-primas e produtos acabados por sua relevância para segurança e conformidade. Caracteriza-se por propriedades cromatográficas e massas específicas identificáveis por HPLC e LC-MS | e exige quantificação precisa para cumprir especificações farmacopéias. Estudos de estabilidade | perfil de pureza e validação de método definem limites aceitáveis e estratégias de redução durante síntese e formulação. A documentação analítica robusta e a rastreabilidade dos resultados suportam controle de qualidade | avaliação de risco e submissões regulatórias.
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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