La impureza EP H de amoxicilina, también denominada Amoxicillin Related Compound H, es un degradante estructuralmente definido del núcleo penámico y no corresponde a una familia de nitrosaminas. El CAS 205826-86-4 identifica esta entidad con fórmula molecular C13H17NO4 y masa molecular de 251.28 g/mol. Su presencia se asocia con vías de hidrólisis, oxidación o reordenamiento durante la síntesis, el almacenamiento o la manipulación de materiales de amoxicilina. Dada la posible superposición cromatográfica con compuestos relacionados, su detección y cuantificación suelen requerir LC-MS/MS, LC-MS de alta resolución y HPLC ortogonal con detección por arreglo de diodos; la confirmación estructural puede apoyarse en RMN.
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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