Japanese–English glossary
Elemental impurities
元素不純物genso fujunbutsu
Metal and other elemental residues in a drug product, coming from catalysts, equipment, container closure systems, excipients and water. ICH Q3D sets permitted daily exposures for each element by route of administration and requires a risk assessment of all potential sources, with testing where the assessment shows it is needed. Suppliers of excipients, process materials and components are routinely asked for elemental impurity statements to feed that assessment. Japanese documents use the term as in ICH Q3D.