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CITALOPRAM / ESCITALOPRAM

Characterised impurities

ImpurityChemical namePharmacopoeia
"C"cyano-1(3H)- isobenzofuranone oxalate 3-(3--
Related compounddimethylaminopropy l)-3-(4- fluorophenyl)-6- cyano-1(3H)- isobenzofuranone oxalate ; (1RS)-1-[3-USP
"C"(dimethylamino)pro pyl]-1- (fluorophenyl(-3- oxo-1,3-dihydro-2- benzofuran-5- carbonitrile oxalate-
Related compound D (Desmethy1-(4-fluorophenyl)-1- methylaminopropyl) -1,3-USP
l Citalopram )dihydroisobenzofura n-5-carbonitrile hydrochloride-
Related compound “E”1-(3- Dimethylaminoprop yl)-1-(4- fluorophenyl)-1,3- dihydroisobenzo furan-5-carbonitrile- N-oxide 1-(3- DimethylaminopropUSP
Related compound “E” (N- Oxide) / Impurity "H"yl)-1-(4- fluorophenyl)-1,3- dihydroisobenzo furan-5-carbonitrile- N-oxide OR Citalopram N-Oxide; 3-[(1RS)-5-cyano-1- (4-fluorophenyl)-1,3- dihydro-2- benzofuran-1-yl]- N,N-USP/EP /BP
Impurity “F” / Related compound “H”dimethylpropan-1- amine-N-oxide 3-[(1RS)-5-bromo-1- (4-fluorophenyl)-1,3- dihydroisobenzofura n-1-yl]-N,N-dimethyl propan-1-1amineBP/EP/ USP
Citalopram Ketone (Impurity "G")(Dimethylamino)-1- {1-[3- Dimethylamino)prop yl]-1-(4- fluorophenyl)-1,3- dihydroisobenzofura 5 yl}butan 1 oneUSP
Impurity "L"/ Desfluoro Citalopram(1RS)-1-[3- (dimethylamino)pro pyl]-1-phenyl-1,3- dihydro-2- benzofuran-5- carbonitrile oxalateEP
IMPURITY- I4~[(1Z)4~ (Dimethylamino)~ 1- (4~f1uorophenyl)but: -yl]-3-(hyd roxymethyl)benzonit rile; Citalopram olefinic; Olefinic ImouritvEP/BP
IMPURITY- Jmethylbenzenesulfo monohydrate; toluenesulfonic acid monohydrate DescyanoEP/BP
IMPURITY- Mcitalopram carboxylic acid; (1RS)-1-[3- (dimethylamino)pro pyl]-1-(4- f1uorophenyl)-1,2- dihydro-2- benzofuran-5-EP/BP
R- Citalopram oxalatecarboxylic acid I-1-[3- (Dimethylamino)pro pyl]-1-(p- fluorophenyl)-5- phthalancarbonitrile oxalateUSP
Racemic cyanodiol[4-)Dimethylamino)- 1-(4-fluorophenyl)-1- hydroxybutyl]-3- (hydroxymethyl)ben zonitrileIHT
N,N- dimethyla mino propyl chloride HClN,N-dimethylamino propyl chloride HClIHT
Cyano diol 2,4- Dibromo-4-[4- (Dimethylamino)-1- (4-fluorophenyl)-1- hydroxybutyl]-3- (hydroxymethyl)ben zonitrile 2,4-Dibromo-1-IHT
1- fluorobenz ene Fluoroben zene Oxalate salt of Ene imp. offluorobenzene 1-Fluorobenzene 5-Cyano-2-(4- (dimethylamino)-1- (4-fluorophenyl)but-IHT IHT IHT
monoacet ylcyanoest er 1-Bromo- 3- Chloropro pane1-en-1-yl)benzyl acetate oxalate 1-Bromo-3- ChloropropaneIHT
Olefin impurity of racemic cyanodiol4-[4- (dimethylamino)-1- (4-fluorophenyl)1- buten-1-yl]-3- (hydroxymethyl)- benzonitrileIHT
5- Carbamoyl phthalide P-Toluic acid1,2-Dihydro-1-oxo-5- isobenzofuran carboxamide 4-Methyl benzoic acidIHT IHT
Impurity E, Racemic cyanodiol hydrobro mide(4RS)-4-[4-cyano-2- (hydroxymethyl)phe nyl]-4-(4- fluorophenyl)-4- hydroxy-N,N- dimethylbutan-1- aminium bromideEP/IHT
“Acrylate”Diethyl {[(3- chlorophenyl)amino] methylidene} propane dioate-

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