Amoxicillin EP Impurity E (CAS 1356020-01-3) | también denominado Amoxicillin Related Compound E | es una impureza procesal y de degradación relevante en la fabricación y control de calidad de amoxicilina. Este compuesto se caracteriza y cuantifica mediante técnicas analíticas validadas como HPLC con detección UV y espectrometría de masas | y su estructura se confirma por RMN cuando es necesario. La presencia de esta impureza se vigila dentro de especificaciones basadas en estudios de estabilidad y riesgo | y su identificación temprana soporta estrategias de mitigación durante el desarrollo y la producción. Documentación técnica y especificaciones garantizan cumplimiento regulatorio y uniformidad analítica.
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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