Donepezil EP Impurity G (Free base), CAS 2452407-72-4, is a defined related substance of donepezil with molecular formula C24H27NO3 and molecular weight 377.5 g/mol. Structurally, it is a tertiary amino arylalkyl ether impurity consistent with a synthetic intermediate-derived or process-related analog rather than a simple oxidation product. Its presence may arise from incomplete elaboration of the benzylpiperidine framework or alkylation side reactions during manufacture. Trace-level characterization generally requires LC-MS/MS for elemental composition confirmation, with HPLC-UV and LC-ELSD supporting assay determination. Where impurity profiling is required, orthogonal MS or high-resolution LC techniques are used to distinguish it from isomeric degradants.
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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