Impureza Amoxicillin EP Impurity E (Amoxicillin Related Compound E | CAS 1356020-01-3) é um marcador crítico de controle de qualidade em lotes de amoxicilina | identificado como subproduto de síntese e degradação. Sua deteção e quantificação são realizadas por métodos validados como HPLC com detecção UV e LC-MS para confirmação estrutural | complementados por RMN quando necessário. A presença desta impureza influencia especificações e limites de aceitação segundo boas práticas regulatórias e diretrizes ICH | exigindo monitoramento em estudos de estabilidade e procedimentos analíticos de liberação de lote para garantir conformidade farmacêutica e integridade do perfil de pureza.
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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