A NOVEL PROCESS FOR THE PREPARATION OF CRYSTALLINE MAGNESIUM SALT OF (S)-OMEPRAZOLE DI HYDRATE

摘要

Disclosed herein is process for preparation of crystalline form of (S)-5-methoxy-2-[[(4- methoxy-3,5-dimethyl-2-pyridinyl)-methyl]sulfinyl]-1H-benzimidazolemagnesium dihydrate which comprises: dissolving (S)-Omeprazole potassium in dimethyl formamide; reacting with magnesium chloride hexa hydrate; removing the salts from the mixture; and precipitating the (S)-Omeprazole magnesium di hydrate crystalline form by adding anti solvent. The anti-solvent used in the above process is selected from the group consisting of ketones such as acetone or methyl isobutyl ketone; esters such as ethyl acetate, and ethers like methyl tertiary butyl ether.