Bupropion 3,4-Dichloro Impurity (CAS 1346598-72-8) ist eine halogenierte, prozessbedingte Verunreinigung des Bupropion-Synthesewegs und entsteht plausibel durch Eintrag chlorierter aromatischer Vorstufen oder Nebenreaktionen in Zwischenstufen. Mit der Summenformel C13H18Cl3NO und einer Molmasse von 310,65 g/mol handelt es sich um ein strukturelles Analogon und nicht lediglich um ein Abbauprodukt. Die Trichlorierung erhöht die chromatographische Hydrophobie und beeinflusst das Ionisationsverhalten, weshalb eine sichere Bestimmung typischerweise LC-MS/MS, hochauflösende LC-MS und, bei geeigneter Derivatisierung, GC-MS erfordert. Die regulatorische Bewertung erfolgt im Rahmen von ICH Q3A/Q3B und einer toxikologischen Qualifizierung nach Schwellenwertprinzipien.
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