N-Pivaloyl Amoxicillin (CAS 1313237-94-3) es una impureza relacionada con el proceso de pivaloilación de la amoxicilina que puede formarse durante la síntesis | purificación o almacenamiento del principio activo. Técnicamente se identifica como un derivado acilado con incremento de masa correspondiente al grupo pivaloil | detectado y cuantificado mediante métodos validados como HPLC con detección UV | LC-MS y confirmación por RMN. Su presencia puede afectar la potencia | perfil de degradación y seguridad del lote | por lo que se controla mediante estrategias de proceso | límites especificados conforme a ICH Q3A/Q3B y ensayos de estabilidad y pureza.
Referencias
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, pp. 631–39, https://doi.org/10.1016/0731-7085(95)01661-9. ‌
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