Process for the preparation of azithromycin dihydrochloride

Details Process for the preparation of azithromycin dihydrochloride Process for the preparation of azithromycin dihydrochloride

C - Chemistry, Metallurgy

07

H

C07H 17/00 (2006.01) C07H 17/08 (2006.01)

Patent

CA 2146475

The present invention refers to a new process for the preparation of azithromycin dihydrochloride, which is a pharmaceutically acceptable salt of the antibiotic azithromycin useful as an antibacterial agent with a broad-spectrum action, the process compriseing reacting azithromycin dihydrate dissolved in a lower (C1-C4) alcohol or lower (C3-C6) ketone with 1.6 to 2 equivalents of hydrogen chloride gas dissolved in a dry lower (C1-C4) alcohol at a concentration of 12-20% (w/v), at a temperature of from 10°C to 15°C, precipitating the obtained product with a non-solvent at a temperature of from 10°C to 25°C, with the ratio of solvent:non-solvent being from 1:1.8 to 1:8 (v/v), and then isolating the obtained product by filtration.

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