Amikacin EP Impurity B, CAS 927821-99-6, es una impureza estructuralmente definida relacionada con amikacina, un antibiótico aminoglucósido semisintético de tipo 4,6-disustituido deoxiestreptamina. Con fórmula molecular C26H50N6O15 y peso molecular 686,71 g/mol, conserva el núcleo aminociclitol polihidroxilado y varias funciones glicosídicas, lo que es coherente con una impureza de proceso o de transformación originada durante la semisíntesis, la hidrólisis o la reorganización epimérica del principio activo. Por su alta similitud estructural con amikacina, su identificación suele requerir LC-MS/MS con espectrometría de masas de alta resolución y separación ortogonal por intercambio iónico o HILIC; la RMN se utiliza para la elucidación estructural.
Referencias
Ristuccia AM, Cunha BA. An overview of amikacin. Therapeutic Drug Monitoring. 1985 ;7(1):12-25. DOI: 10.1097/00007691-198503000-00003. PMID: 3887667.http://europepmc.org/article/med/3887667 Wang, Jian, et al. “Separation and Characterization of Unknown Impurities in Amikacin Sulfate by HPLC–MS N.†Chromatographia, vol. 78, no. 15-16, Springer Science+Business Media, May 2015, pp. 1031–39, https://doi.org/10.1007/s10337-015-2909-8 . Accessed 26 Oct. 2023.
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