InphA GmbH and World Health Organization (WHO) have initiated a project aiming at the revision of monographs of the International Pharmacopoeia (IP). The IP is a collection of procedures (called “monographs”) for the testing of essential medicines and their active pharmaceutical ingredients. In some of the monographs reagents are still being used which nowadays would be replaced with more suitable ones. Concretely our cooperation with WHO is about avoiding the use of the toxic reagent mercuric acetate, which is being used in certain IP monographs for the quantitative analysis of weak bases by titration.
Mercuric acetate is harmful to humans and the environment and therefore its use should be avoided. Whenever possible harmonization of the IP with alternative methods described in other pharmacopoeias avoiding the use of mercuric acetate is pursued. If such methods are not available, new methods have to be developed. The respective monographs involve active substances that are characterized as halide salts of organic bases and quaternary ammonium compounds. For the halide salt quinine dihydrochloride, which is in combination with Doxycycline used for treatment of acute malaria, no alternative method exists. Also for the monograph of the antibiotic Moxifloxacin, which is still to be included into the IP, the use of mercuric acetate shall be avoided.
Therefore InphA is developing and validating mercuric acetate free quantitative analytical methods in cooperation with WHO. The tests are performed by a pharmacist in training as part of the academic education with support from a supervising pharmacist.