A Impureza EP H da amoxicilina, também designada Amoxicillin Related Compound H, é um produto de degradação estruturalmente definido derivado do núcleo penâmico e não se enquadra na classe das nitrosaminas. O CAS 205826-86-4 identifica a entidade com fórmula molecular C13H17NO4 e massa molecular de 251.28 g/mol. Sua ocorrência está associada a vias de hidrólise, oxidação ou rearranjo durante a síntese, o armazenamento ou o manuseio de materiais de amoxicilina. Como pode haver sobreposição cromatográfica com espécies relacionadas, a caracterização geralmente exige LC-MS/MS, LC-MS de alta resolução e HPLC ortogonal com detecção por arranjo de diodos; a confirmação estrutural pode recorrer a RMN.
Referências
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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