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Eszopiclone

Human API

Characterised impurities

ImpurityChemical namePharmacopoeia
“ CCPC” Impurity II3-(5-chloropyridin-2- ylcarbamoyl)pyrazin e-2-carboxylic acid N-(5-chloropyridin- 2-yl)-3- (hydroxymethyl)pyra zine-2-carboxamideIHT IHT
Impurity III-IHT
Impurity IVbis(4- methylpiperazin-1- yl)methanoneIHT
Impurity IX7-Hydroxy-6- (pyridine-2-yl)-6,7- dihydro-5H- pyrrolo[3,4- b]pyrazin-5-oneIHT
“R-Isomer” of Zopiclone(+)-(5R)-6-(5- Chloropyridin-2yl)-7- oxo-6,7-dihydro- 5N- pyrrolol[3,4,b]pyrazi n-5-yl-4-methyl Piperazine carboxylateIHT
Impurity “B”RS)-6-(5- chloropyridin-2- yl)-7-hydroxy-6,7- dihydro-5H- pyrrolo[3,4- b]pyrazin-5-one (CPHP)EP
Impurity “A”6-(5-Chloro-2- Pyridin-2-yl)-6,7- dihydro-7-oxo-5H- Pyrrolo-[3,4-b] Pyrazin-5-yl-4- methylpiperazine-1- carboxylate 4-oxide (Zopiclone n-oxide) 6-(5-Chloropyridine- 2-yl)-5H-USP
"CPDO" Impurity “C”pyrrolol[3,4- b]pyrazine-5,7(6H)- dione 6-(5-chloropyridin-2- yl)-6,7-dihydro-5H- pyrrolo[3,4- b]pyrazin-5-oneIHT BP/EP
"PMC" impurity "PDCA" impurity Des methyl Impurity “A”Pyrazine-2- carboxylic acid Furo[3,4-b]pyrazine- 5,6-dione 6-(5-chloropyridin-2- yl)-7-oxo-6,7- dihydro-5H- pyrrolo[3,4- b]pyrazin-5-yl (4-chlorophenyl)(4- hydroxyphenyl)meth anoneIHT IHT IHT USP/B P/EP
Impurity “B”2-[4-(4- Chlorobenzoyl)phen oxy]-2- methylpropanoic acid; Fenofibric acidEP

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