Acetylcysteine Impurity 1 (Natriumsalz), CAS 15058-19-2, ist das Natriumsalz einer acetylcysteinbezogenen Thiolcarbonsäure mit der Summenformel C5H6NNaO2S und einem Molekulargewicht von 167,16 g/mol. Die Verbindung entspricht einer prozess- oder abbauabhängigen ionischen Spezies, die durch Deacetylierung, Thioloxidation oder Salzumsetzung während Synthese und Lagerung schwefelhaltiger mukolytischer Zwischenprodukte entstehen kann. Aufgrund der hohen Polarität werden zur Identifizierung und Quantifizierung typischerweise LC-MS/MS, Ionenchromatographie und NMR eingesetzt, während GC-MS nur eingeschränkt geeignet ist. Regulatorisch wird ein solcher Schwefelverunreinigungsbefund im Hinblick auf Oxidationsstabilität, Spezifikationsgrenzen und Chargenvariation bewertet.
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