Risk Assessment and Control in the Guideline for Elemental Impurities in Drugs
The original article by Rina Nishioka, Soichiro Hanakawa of the Sumika Chemical Analysis Service, Ltd., appeared in an e-newsletter of FUJIFILM Wako Pure Chemical Corporation and was translated by the company.
A regulatory guideline for elemental impurities in drug products was formulated by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). In Jap...