Amikacin EP Impurity B（CAS 927821-99-6）は、半合成4,6-二置換デオキシストレプタミン系抗菌薬アミカシンに関連する構造規定不純物である。分子式C26H50N6O15、分子量686.71 g/molを有し、多価ヒドロキシル化されたアミノシクロイトール骨格と複数の配糖結合を保持することから、半合成工程、加水分解、または母核のエピマー化再配列に由来する工程関連または変換由来不純物と解釈される。アミカシンとの構造類似性が高いため、検出・定量には高分解能LC-MS/MSに加え、イオン交換またはHILICによる直交分離が通常必要であり、構造解析にはNMRが用いられる。
References
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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