Acetylcystein EP Verunreinigung A, bezeichnet als L-Cystin oder Cystin (CAS 56-89-3), ist das symmetrische Disulfid-Oxidationsprodukt zweier L-Cystein-Einheiten und ein aus der Thiolchemie stammendes Prozess- oder Lagerungsabbauprodukt. Die Summenformel lautet C6H12N2O4S2 bei einer Molekülmasse von 240,30 g/mol. Die Bildung wird durch Sauerstoff, Spurenmetalle oder ungeeigneten pH-Wert während Herstellung und Handhabung begünstigt. Da es sich um eine nicht genotoxische Oxidationsverunreinigung einer Aminosäure und nicht um ein Nitrosamin handelt, erfolgt die Bewertung üblicherweise über verunreinigungsspezifische Spezifikationen. Die Bestimmung erfordert meist LC-MS/MS, HILIC-LC oder Ion-Pair-Reversed-Phase-Chromatographie mit UV- oder MS-Detektion.
References
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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