Amikacina EP Impureza H, CAS 48237-20-3, es una impureza de proceso estructuralmente definida relacionada con los aminoglucósidos y asociada al esqueleto heptosa/aminociclitol de la amikacina, con fórmula molecular C22H44N6O12 y peso molecular 584.62 g/mol. El analito corresponde a una variante cromatográfica estrechamente emparentada que puede originarse por glicolisación incompleta, transglicosilación o transformación tardía durante la fabricación de aminoglucósidos semisintéticos. Debido a su arquitectura muy polar, policatiónica y ricamente oxigenada, la separación suele requerir LC de par iónico o HILIC acoplada a MS de alta resolución o LC-MS/MS para su elucidación a nivel traza. En el perfilado regulatorio de impurezas, estas especies se consideran por su posible impacto en potencia, respuesta microbiológica y límites de especificación.
Referencias
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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