To provide a process for obtaining cefepime dihydrochloride monohydrate from synthetic cefepime.
A synthetic cefepime solution is bleached with carbon, sterilely filtered and treated with a concentrated hydrochloric acid to pH 0.4-0.6 at 15-30°C. Then the solution is crystallized and a water-miscible organic solvent is added to the solution at 20-30°C until sterilized cefepime dihydrochloride monohydrate is completely precipitated. Then, after filtration, the precipitate is redissolved in a solvent selected from methanol and water, the solution is sterilely filtered and the solution is diluted with the organic solvent so as to induce crystallization. The produced crystal is filtered, washed with acetone and dried under vacuum to 3.0-4.5% K.F.
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FILIPPI MAURO
Makoto Ono
Chihiro Watanabe
Kenkyo Kanayama
Katsuma Osaki
Mitsuaki Tsubokura