Amoxicillin Related Compound 2 es una impureza relacionada con amoxicilina que aparece como subproducto de síntesis o mediante degradación durante almacenamiento. Su identificación y cuantificación son críticas en el control de calidad farmacéutico | ya que puede afectar el perfil de pureza | la potencia y la seguridad del lote. Se caracteriza por estudios cromatográficos y espectrométricos | típicamente detectada por HPLC con método validado y confirmada por MS y RMN para estructuración. Los límites de aceptación se establecen según guías regulatorias y evaluación toxicológica | por lo que su monitoreo en el perfil de impurezas y en estudios de estabilidad es esencial.
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.†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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