The present invention relates to a novel cocrystal, a pharmaceutical composition comprising same and a preparation method therefor. By using the cocrystal of the present invention, cancers, inflammatory diseases, or viral infection diseases may be effectively prevented and/or treated.

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 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 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.

The present disclosure provides a preparation method for metformin hydrochloride. The preparation method includes: microwave heating raw materials containing dicyandiamide and dimethylamine hydrochloride, and reacting the two at 100° C. to 160° C. to obtain a product system containing metformin hydrochloride. Microwave heating is adopted to heat the dicyandiamide and the dimethylamine hydrochloride. Compared with a conventional heating mode that requires heat to be gradually transferred from the outside to the inside, microwave heating can directly heat each part inside the reactant, which can make the internal temperature of the reactant more uniform, thereby reducing the generation of impurities.

The present disclosure provides a preparation method for metformin hydrochloride. The preparation method includes: microwave heating raw materials containing dicyandiamide and dimethylamine hydrochloride, and reacting the two at 100° C. to 160° C. to obtain a product system containing metformin hydrochloride. Microwave heating is adopted to heat the dicyandiamide and the dimethylamine hydrochloride. Compared with a conventional heating mode that requires heat to be gradually transferred from the outside to the inside, microwave heating can directly heat each part inside the reactant, which can make the internal temperature of the reactant more uniform, thereby reducing the generation of impurities.

The present disclosure is directed to methods for performing size exclusion chromatography. Embodiments of the present disclosure feature methods for improving separations of proteinaceous analytes in size exclusion chromatography, for example, by using low concentrations of amino acids or derivatives thereof in the mobile phase.

The present disclosure is directed to methods for performing size exclusion chromatography. Embodiments of the present disclosure feature methods for improving separations of proteinaceous analytes in size exclusion chromatography, for example, by using low concentrations of amino acids or derivatives thereof in the mobile phase.

An object of the present invention is to provide a crystal of an amino acid salt of HMB which is easy to handle and has high solubility, and to provide a method for producing the same. According to the present invention, the crystal of an amino acid salt of HMB can be precipitated by dissolving an amorphous amino acid salt of HMB in a solvent containing alcohol and stirring or allowing the solvent to left stand. In addition, the crystal of an amino acid salt of HMB can be precipitated by concentrating an aqueous HMB solution of an amino acid salt which has a pH of 2.5 to 11.0.

An object of the present invention is to provide a crystal of an amino acid salt of HMB which is easy to handle and has high solubility, and to provide a method for producing the same. According to the present invention, the crystal of an amino acid salt of HMB can be precipitated by dissolving an amorphous amino acid salt of HMB in a solvent containing alcohol and stirring or allowing the solvent to left stand. In addition, the crystal of an amino acid salt of HMB can be precipitated by concentrating an aqueous HMB solution of an amino acid salt which has a pH of 2.5 to 11.0.