917805-75-5Relevant academic research and scientific papers
PROCESS FOR THE PREPARATION OF ROSUVASTATIN
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Page/Page column 52, (2010/08/08)
The invention relates to a process for the preparation of a HMG - CoA reductase inhibitor such as rosuvastatin, as well as intermediates useful in such process. The invention also relates to salts of HMG-CoA reductase inhibitors and processes for preparing same as well as processes for preparing pharmaceutically acceptable salts of HMG-CoA reductase inhibitors.
PROCESS FOR PREPARING AMORPHOUS ROSUVASTATIN CALCIUM FREE OF IMPURITIES
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Page/Page column 13-14, (2008/06/13)
A pure amorphous form of rosuvastatin calcium having purity of more than 99.5%, preferably a purity of more than 99.8%, more preferably a purity of more than 99.9% as determined by HPLC area percentage, and free from any traces of alkali metal impurities is disclosed. A process of preparing said pure amorphous form of rosuvastatin calcium is disclosed, which comprises hydrolysis of C1-C5 alkyl esters of rosuvastatin, preferably terf-butyl ester of rosuvastatin, with an organic nitrogen base, e.g. guanidines, amidines, amines and quaternary ammonium hydroxides, in the presence of water, optionally containing aprotic solvent, following the conversion of thus obtained rosuvastain salt with a source of calcium to desired rosuvastatin calcium, which is then isolated. An alternative process is disclosed, which comprises the conversion of numerous novel ammonium salts of rosuvastatin, preferably tert-octylammonium salt of rosuvastatin, with the source of calcium to desired commercial rosuvastatin calcium.. Rosuvastatin calcium is HMG CoA reductase, useful in the treatment of hyperlipidemia, hypercholesterolemia and atherosclerosis.
