A Impureza EP B da acetilcisteína corresponde à L-cisteína, CAS 52-90-4, um aminoácido contendo enxofre com fórmula molecular C3H7NO2S e massa molecular de 121,16 g/mol. No insumo farmacêutico acetilcisteína, está geralmente associada à acetilação incompleta, à desacetilação hidrolítica ou ao arraste do precursor de síntese. Como impureza de प्रक्रिया não mutagênica, e não como nitrosamina ou espécie genotóxica, sua relevância é predominantemente farmacopeica e composicional. A quantificação normalmente exige LC-MS/MS, HPLC com par iônico ou derivatização, e, por vezes, eletroforese capilar para resolver espécies tiol relacionadas.
Referências
Toussaint, B., et al. “Quantitative Analysis of N-Acetylcysteine and Its Pharmacopeial Impurities in a Pharmaceutical Formulation by Liquid Chromatographya-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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