Analytical methods for analyzing and determining impurities in dianhydrogalactitol
AssigneeDel Mar Pharmaceuticals
InventorXiaoyun Lu
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Abstract
An improved analytical method for analysis of dianhydrogalactitol preparations provides a method for determining the purity of dianhydrogalactitol and detecting impurities in preparations of dianhydrogalactitol, as well as identifying any such impurities. The method employs high performance liquid chromatography (HPLC), in particular, HPLC with refractive index (RI) detection; the HPLC can be followed by tandem mass spectroscopy. The method can further comprise the step of performing preparative HPLC collection of at least one specific substance peak present in a preparation of dianhydrogalactitol.
Claims42
An analytical method for analyzing the presence and quantity of impurities present in a preparation of dianhydrogalactitol comprising the steps of:
- (a) analyzing a preparation of dianhydrogalactitol by subjecting the preparation to high performance liquid chromatography using elution with a mobile phase gradient to separate dianhydrogalactitol from dulcitol and other contaminants of the preparation;
- and
- (b) determining the relative concentration of one or more peaks resolved by high performance liquid chromatography that represent compounds other than dianhydrogalactitol itself.
An analytical method comprising:
- (a) analyzing a preparation of dianhydrogalactitol by subjecting the preparation to high performance liquid chromatography using elution with an isocratic mobile phase to separate dianhydrogalactitol from dulcitol and other contaminants of the preparation;
- and
- (b) determining the relative concentration of one or more peaks resolved by high performance liquid chromatography that represent compounds other than dianhydrogalactitol itself.
Dependencies are inferred from the claim text.