Hyoscine Butylbromide EP Impurity G, auch als Hyoscine Apo-N-Butyl Impurity bezeichnet, ist ein strukturell definiertes Tropanalkaloid-Derivat mit der Summenformel C21H28NO3 und einer Molmasse von 342,45 g/mol. Es entspricht einem dequaternisierten oder umlagerungsbedingten Abbauprodukt, das aus Spaltungs- oder Eliminierungsprozessen des butylierten Scopolamin-Gerüsts während der Synthese oder unter Belastung entstehen kann. Als Nicht-Nitrosamin-Verunreinigung liegt die regulatorische Bedeutung in der Verunreinigungscharakterisierung und Spezifikationsableitung nach pharmakopöischen Anforderungen. Der Nachweis erfordert üblicherweise LC-MS/MS zur Identitätsbestätigung und Spurenbestimmung, ergänzt durch LC-HRMS und orthogonale chromatographische Trennung zur Peakzuordnung und Verunreinigungsabgrenzung.
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