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Donepezil

Human API

Characterised impurities

ImpurityChemical namePharmacopoeia
TAPS PCP impurity RCP impuritydimethoxy-2,3- dihydro-1H-indene- 1-one 2,4,5,6-tetraamino pyrimidine suphate (2E)-5,6-dimethoxy- 2-(pyridine-4- ylmethylidine)-3H-1- one 5,6-Dimethoxy-2- (piperidin-4- ylmethylidine)indan- 1-one ; Desbenzyl Donepezil (USP)IHT IHT IHT
Dimer impurity Dibenzyl Impurity Donepezil- N-Oxide Donepezib enzyl (USP- Quatarnar y salt)2-(3-(3,4- dimethoxyphenyl)-3- oxopropyl)-5,6- dimethoxy-2,3- dihydro-1H-inden-1- one 4-[(2,3-dihydro-5,6- dimethoxy-1-oxo-1H- inden-2- yl)methyl]-1,1- bis(phenylmethyl)pi peridinum chloride 1-Benzyl-4-[5,6- dimethoxy-1-oxo- 2,3-dihydro-1H- inden-2- yl)methyl]piperidine- oxide (1,1-dibenzyl-4-[(5,6- dimethoxy-1-oxo- 2,3-dihydro-1H- inden-2- yl)methyl]piperidiniu or (1,1-dibenzyl- 4-[(5,6-dimethoxy-1- oxoindan-2- yl)methyl]piperidiniuIHT IHT USP IHT
Impurity “C”2-[(1RS)-8-ethyl-1- methyl-1,3,4,9- tetrahydro pyrano[3,4-b]indol- 1-yl]acetic acid (1- methyl Etodolac)BP/EP/ USP
Impurity "D" (8- Isopropyl Etodolac)[(1RS)-1-Ethyl-8-)1- methylethyl)-1,3,4,9- tetrahydrofuran[3,4- b]indol-1-yl)acetic acidEP/BP
Impurity "G" (1- propyl etodolac)[(1RS)-8-ethyl-1- propyl)-1,3,4,9- tetrahydrofuran[3,4- b]indol-1-yl]acetic acidBP/EP

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