Amikacin EP Impurity E (CAS 50866-72-3) is a defined aminoglycoside-related process and degradant impurity associated with the kanamycin-derived aminocyclitol scaffold of amikacin. With molecular formula C22H43N5O13 and molecular weight 585.6 g/mol, it retains the polyhydroxylated, polycationic profile characteristic of this class, indicating a closely related structural variant rather than a low-mass reagent contaminant. Its occurrence is typically linked to incomplete functional group transformation or downstream degradation during manufacture and storage. Determination generally requires orthogonal LC-MS/MS, high-resolution LC-MS, and ion-pair or hydrophilic interaction LC methods, with derivatization or MS optimization often necessary for trace-level quantification in pharmacopoeial impurity profiling.
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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