Elemental impurities


The “Guideline for Elemental Impurities” ICH Q3D, published on the 18 th of December 2014 regulates the control of potentially toxic elemental impurities in human medicines and impose a new step to characterize the product for both API (Active Pharmaceutical Ingredient) manufacturers and drug product manufacturers.



  • The Guideline ICH Q3D defines 4 classes of elements depending on toxicity and probability of occurrence in the drug products: 

Class 1 (As, Cd, Hg, Pb), Class 2A (Co, Ni, V), Class 2B (Ag, Au, Ir, Os, Pd, Pt, Rh, Ru, Se, TI) and Class 3 (Ba, Cr, Cu, Li, Mo, Sb, Sn).

  • The guideline includes the PDE (Permitted Daily Exposure), in µg/day, for all the 24 elements for the oral, parenteral and inhalation routes of administration.


  • The guideline proposes a 3 steps risk-based control strategy :

               1. Identify known and potential sources of elemental impurities that may find their way into the drug product :

               2. Evaluate the presence of a particular elemental impurity in the drug product by determining the observed or predicted level of the impurity and comparing with the established PDE.          

               3. Summarize and document the risk assessment. Identify if controls built into the process are sufficient or identify additional controls to be considered to limit elemental impurities in the drug product.


We develop Elemental Impurities Implementation of Risk Assessment Reports, for both API manufacturers and drug product manufacturers. You can contact us regarding a QUOTATION REQUEST for an ICH Q3D report development.


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