Acetylcysteine Impurity 14 (DiHCl), CAS 438542-17-7, bezeichnet das Dihydrochlorid eines cysteinabgeleiteten schwefelhaltigen Basenverunreinigungsstoffs mit der Summenformel C8H17N3O2S. 2 HCl und einer Molekülmasse von 219,31 plus 2 x 36,46 g/mol. Die Struktur spricht eher für ein prozessbedingtes oder umwandlungsbedingtes Nebenprodukt aus der Acetylcystein-Synthese, Salzbildung oder nachfolgender Aminierung als für ein klassisches Nitrosamin. Aufgrund der hohen Polarität erfolgt die Charakterisierung üblicherweise mittels LC-MS/MS oder hochauflösender LC-MS; für ausreichende Retention können auch Ionenchromatographie oder HILIC-Verfahren erforderlich sein. Regulatorisch relevant sind Identitätsbestätigung, Verunreinigungsprofil und gegebenenfalls die Qualifizierung nach ICH-Anforderungen.
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