Elemental impurities: how to be compliant with ICH Q3D guideline?
CPhI ISCE 2015
On January 1st 2018, all new and existing drug products will have to comply with the ICH Q3D guideline for elemental impurities (EIs). Although this guideline sets
specifications for drug products only, the risk assessment approach also involves the determination of metallic impurities in APIs and excipients.