La impureza EP A de acetilcisteína, identificada como L-cistina o cistina (CAS 56-89-3), es el producto de oxidación disulfuro simétrico de dos unidades de L-cisteína y un degradante de proceso o almacenamiento derivado del tiol. Su fórmula molecular es C6H12N2O4S2 y su peso molecular es 240,30 g/mol. La formación se favorece por la exposición al oxígeno, metales traza o pH inadecuado durante la fabricación y el manejo. Al tratarse de una impureza de oxidación de aminoácido no genotóxica y no de una nitrosamina, suele evaluarse mediante especificaciones específicas de impurezas. La cuantificación requiere habitualmente LC-MS/MS, HILIC-LC o cromatografía de fase reversa con par iónico y detección UV o MS.
Referencias
Toussaint, B., et al. Quantitative Analysis of N-Acetylcysteine and Its Pharmacopeial Impurities in a Pharmaceutical Formulation by Liquid Chromatography “UV Detection “Mass Spectrometry. Journal of Chromatography A, vol. 896, no. 1-2, Oct. 2000, pp. 191-99, https://doi.org/10.1016/s0021-9673(00)00741-x.
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