Donepezil EP Impurity G (freie Base), CAS 2452407-72-4, ist eine definierte verwandte Substanz von Donepezil mit der Summenformel C24H27NO3 und einer Molmasse von 377,5 g/mol. Strukturell handelt es sich um eine tertiäre aminoaromatische Alkylether-Verbindung, die eher einem prozessbedingten oder aus Vorstufen stammenden Analogon als einem einfachen Oxidationsprodukt entspricht. Ihr Auftreten kann aus unvollständiger Umsetzung des Benzylpiperidin-Gerüsts oder aus Alkylierungsnebenreaktionen während der Herstellung resultieren. Die Spurennachweischarakterisierung erfordert üblicherweise LC-MS/MS zur Bestätigung der Elementarzusammensetzung, während HPLC-UV und LC-ELSD die Gehaltsbestimmung unterstützen. Für die Verunreinigungsprofilierung werden orthogonale MS- oder hochauflösende LC-Verfahren zur Trennung von isomeren Abbauprodukten eingesetzt.
References
Birks, J. S., & Harvey, R. J. (2018). Donepezil for dementia due to Alzheimer’s disease. Cochrane Database of Systematic Reviews, 2018(6). https://doi.org/10.1002/14651858.cd001190.pub3
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