And a method for preparing new crystalline form of pantoprazole sodium compound

2015 
The present invention relates to a novel form and method of preparation of pantoprazole sodium, it is defined with the angle of diffraction peaks characteristic X- ray powder diffraction pattern and DSC 2θ °. The pantoprazole sodium is added an organic solvent to prepare a 0.05 ~ 0.2g / mL suspension of the solid was added after complete dissolution controlling crystal nucleation additives 15 ~ 35 ℃, then added dropwise to the eluent solution, eluent used in an amount of 3 to 10 times the volume of the solvent, and then cooled to 0 to 10 deg.] C, stirred for 1 ~ 3h, the suspension formed is suction filtered and dried to give a new compound pantoprazole sodium crystal form N product. Product has a higher bulk density and better flow properties, bulk density 20% higher than has been reported in Patent polymorph, while the Form new products due to the larger size, higher crystallinity, and therefore a higher purity of the product may be 99.5%. New crystalline form has more advantages in the processing of tablets and powder injection dosage form.
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