InphA GmbH is conducting a project in cooperation with the World Health Organisation (WHO) to revise monographs of the International Pharmacopoeia. The International Pharmacopoeia is a collection of regulations for the testing of essential medicines and their drug substances, known as “monographs”. In some of these, reagents are still used for which, from today’s point of view, there are more suitable alternatives. The concrete objective of our cooperation with the WHO is to avoid the use in the International Pharmacopoeia of the toxic reagent mercury acetate, which is used to determine the content of weak bases by titration.
Mercury acetate is a harmful substance for humans and the environment. For this reason, mercury acetate should no longer be used in the future. As far as possible, harmonisation with alternative methods in other pharmacopoeias is sought. If such alternative methods are not described there, new methods are to be developed that do not require the use of toxic reagents. The monographs in question are a group of medicinal substances which are chemically assigned to the halogen salts of organic bases or quaternary ammonium compounds. For the halogen salt quinine dihydrochloride, which is used in the therapy of acute malaria in combination with doxycycline, no alternative method existed until now. The use of mercury acetate should also be avoided for the antibiotic moxifloxacin hydrochloride (also a halogen salt), which is to be newly included in the International Pharmacopoeia.
The development and validation of mercury acetate-free content determinations for these active substances is therefore being carried out by InphA in cooperation with the WHO. The investigations are carried out by a pharmacist in practical training as part of her practical training after her pharmacy studies, with the support of her supervising pharmacist.