The reference compound 4-(2-azido-3-methyl-5-oxotetrahydrofuran-2-yl)phenylhydrazonopropanedinitrile and its use as a reference compound in the determination of potentially genotoxic impurities in samples of a levosimendan batch

摘要

The compound [[4-(2-azido-3-methyl-5-oxotetrahydrofuran-2-yl)phenyl]hydrazono]propa nedinitrile (I) and diastereoisomers thereof are described. A reference preparation for the determination of potentially genotoxic impurities in samples of a levosimendan batch comprising the compound of formula (I) is also described. Also described is an analytic method for the determination of potentially genotoxic impurities in samples of a levosimendan batch characterised in that the compound of formula (I) is used as a reference compound.