Preparation of metformin hydrochloride free from genotoxic impurity
AssigneesExemed Pharmaceuticals, Cadila Healthcare Limited
InventorsPranav Dushyantbhai PATEL, Mayurkumar Lalitbhai GURJAR, Pravinchandra Jayantilal VANKAWALA, Amit Chimanbhai PATEL
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Abstract
A high purity metformin hydrochloride, having a purity equal to or greater than 99% by area percentage of LCMS and no detectable amount of N-Nitrosodimethylamine (NDMA), wherein the LCMS method for the determination of NDMA content in Metformin hydrochloride has a Limit of detection of 0.004 ppm and a Limit of quantification of 0.009 ppm.
Claims13
A high purity metformin hydrochloride, having a purity equal to or greater than 99% by area percentage of LCMS and no detectable amount of N-Nitrosodimethylamine (NDMA), wherein the LCMS method for the determination of NDMA content in Metformin hydrochloride has a Limit of detection of 0.004 ppm and a Limit of quantification of 0.009 ppm.
A pharmaceutical composition comprising metformin hydrochloride having a purity equal to or greater than 99% by area percentage of LCMS and NDMA in an amount less than TTC 0.035 ppm and one or more pharmaceutically acceptable carriers, excipients or diluents.
A pharmaceutical composition comprising metformin hydrochloride having a purity equal to or greater than 99% by area percentage of LCMS and NDMA in an amount less than TTC 0.035 ppm, alone or in combination with at least another therapeutic agent in the presence of a pharmaceutically acceptable carrier.
A method for treating diabetes in patients comprising administering a therapeutically effective amount of a pharmaceutical composition comprising metformin hydrochloride having a purity equal to or greater than 99% by area percentage of HPLC and NDMA in an amount less than TTC 0.035 ppm, alone or in combination with at least another therapeutic agent in the presence of a pharmaceutically acceptable carrier.
Dependencies are inferred from the claim text.