… all manufacturers to carry out a risk assessment to control elemental impurities in their DP. Such evaluation needs to consider all potential sources of Elemental Impurities and obviously, drug product components …

… products will have to comply with the ICH Q3D guideline for elemental impurities (EIs) and on 1st January 2018, all existing … for all drug substances, excipients and drug products. … Elemental Impurities: How to be compliant with Q3D ? … …

… products will have to comply with the ICH Q3D guideline for elemental impurities (EIs). Although this guideline sets … of metallic impurities in APIs and excipients. … … Elemental impurities: how to be compliant with ICH Q3D …

… products.  Drug product manufacturers will soon require Elemental Impurities (EIs) specifications and/or batch analysis for … regulation changes. Our concept consists of quantifying all elemental impurities using a fast, cost-effective generic …