Amoxicillin EP Impurity F (CAS 126247-63-0) | también conocida como Amoxicillin Related Compound F | es una impureza relacionada observada en lotes de amoxicilina que requiere vigilancia por su impacto en la calidad y seguridad del medicamento. Desde el punto de vista técnico se caracteriza como un derivado estructural detectable por métodos cromatográficos validados como HPLC con detectores UV o MS para cuantificación y perfilado. Su presencia sirve como indicador de degradación o reacciones secundarias durante síntesis y almacenamiento | por lo que se aplican límites analíticos y estrategias de control de proceso para minimizarla | incluyendo optimización de etapas de purificación y condiciones de estabilidad conforme a Farmacopea Europea.
Referencias
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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