Abstract:
Disclosed is ranolazine, or a composition containing ranolazine, which is free, or substantially free, of potential genotoxicity wherein 2-(2-methoxyphenoxy)- methyloxirane is present in an amount equal to or less than 750 ppb (w/w) relative to ranolazine, and provides a process for preparing the same. Also disclosed is a method for determining the purity of ranolazine, wherein 2-(2-methoxyphenoxy)- methyloxirane is employed as a reference marker and/or standard.
Abstract:
Disclosed is a process for preparing purified ranolazine of formula (I), which is indicated for the chronic treatment of angina, comprising reacting l-[(2,6- dimethylphenyl)aminocarbonyl]piperazine with l-phenoxy-2,3-epoxypropane in an inert solvent followed by precipitating the ranolazine.