Amikacin EP Impurity E (CAS 50866-72-3) ist eine definierte prozess- und degradationsbedingte Verunreinigung aus dem Aminoglykosid-Bereich, die mit dem kanamycinabgeleiteten Aminocyclitol-Gerüst von Amikacin verknüpft ist. Mit der Summenformel C22H43N5O13 und einer Molekülmasse von 585,6 g/mol bewahrt sie den polyhydroxilierten, polykationischen Charakter dieser Stoffklasse und weist damit auf eine eng verwandte Strukturvariante hin. Ihr Auftreten ist typischerweise auf unvollständige funktionelle Umsetzung oder nachfolgende Zersetzung während Synthese, Aufarbeitung und Lagerung zurückzuführen. Die Bestimmung erfordert gewöhnlich orthogonale LC-MS/MS, hochauflösende LC-MS sowie Ionenaustausch- oder HILIC-Methoden, häufig ergänzt durch Derivatisierung oder MS-Optimierung für die Spurenanalytik im pharmakopöischen Impuritäsprofil.
References
Wang, Jian, et al. “Separation and Characterization of Unknown Impurities in Amikacin Sulfate by HPLC–MS N.†Chromatographia, vol. 78, no. 15-16, May 2015, pp. 1031–39, https://doi.org/10.1007/s10337-015-2909-8.?Adams, E., et al. “Analysis of Amikacin by Liquid Chromatography with Pulsed Electrochemical Detection.†Journal of Chromatography A, vol. 819, no. 1-2, Sept. 1998, pp. 93–97, https://doi.org/10.1016/s0021-9673(98)00394-x.
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