Elemental impurities: how to be compliant with ICH Q3D guideline?

Philippe De Raeve
Pascal Brichart
Julius Bianga
Géry Van Vyncht
Arnaud Delobel
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.