Amikacin EP Impurity H, CAS 48237-20-3, is a structurally defined aminoglycoside-related process impurity associated with the amikacin heptose/aminocyclitol scaffold and the molecular composition C22H44N6O12, molecular weight 584.62 g/mol. The analyte represents a closely related chromatographic variant arising from incomplete glycosylation, transglycosylation, or late-stage transformation within semisynthetic aminoglycoside manufacture. Owing to its polar, polycationic, and highly oxygenated architecture, separation typically requires ion-pair or HILIC LC coupled with high-resolution MS or LC-MS/MS for trace-level elucidation. In pharmaceutical impurity profiling, such species are assessed under impurity control principles because small structural differences can affect potency, microbiological response, and specification setting.
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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