Ambazone Monohydrate and its Impurities
Ambazone Monohydrate was patented in 1957 by Bayer under the trade name Iversal, and briefly used in Germany. It is still used in Russia, countries of the former Soviet Union, Poland and Romania. it is indicated in the treatment of infections of the mouth and throat, including tonsillitis, gingivitis, stomatitis, as well as after tonsillectomy, after tooth extraction. Reference standards of Ambazone Monohydrate API,and its pharmacopeial, non pharmacopeial impurities, and stable isotopes are listed below.