Patent ID: 9029164
Filing Date: 2015-05-12
Classification: G01N,Y10T

Abstract:
1. An analytical method for analyzing the presence and quantity of impurities present in a preparation of dianhydrogalactitol comprising the step of: analyzing a preparation of dianhydrogalactitol by subjecting the preparation to high performance liquid chromatography (HPLC) on an HPLC column using elution with a mobile phase gradient to separate dianhydrogalactitol from dulcitol and other contaminants of the preparation, wherein the HPLC column is a silica gel column bonded to C 18 compounds and finished with an endcapping procedure employing Lewis acid-Lewis base chemistry, wherein the mobile phase gradient comprises Mobile Phase A and Mobile Phase B, with Mobile Phase A being 0.05% formic acid in water and Mobile Phase B being 100% methanol, wherein a first elution sequence is performed with a gradient of 95% water/5% acetonitrile to 70% water/30% acetonitrile, returning to 95% water/5% acetonitrile, wherein following the first elution sequence, a second elution sequence is performed as follows: from 0 minutes to 7.5 minutes with 100% of 0.05% formic acid; from 7.5 minutes to 7.6 minutes with 97% of 0.05% formic acid and 3% of methanol; and from 7.6 minutes to 20 minutes with 100% of 0.05% formic acid, and wherein the high performance liquid chromatography employs evaporative light scattering detection (ELSD).