Implementation of the ICH Q3D Directive

ICH Q3D reports 4 classes of elemental impurities, including heavy metals, according to their toxicological impact and their degree of presence in pharmaceutical products:

  • Class 1: As, Pb, Cd, Hg
  • Class 2a: Co, V, Ni
  • Class 2b: Ag, Au, Tl, Pd, Pt, Ir, Os, Rh, Ru, Se
  • Class 3: Sb, Ba, Li, Cr, Cu, Sn

The guideline is divided into three parts:


Evaluation of toxicology data for each potential elemental impurity 


Calculation of the PDE (permitted daily exposure), i.e. the daily exposure considered acceptable for the user, for each impurity


Risk analysis to control elemental impurities

A dedicated analytical park...

  • Analysis of heavy metals and elemental impurities ICH Q3D by ICP-MS and ICP-MS/MS
  • Analysis of heavy metals and elemental impurities ICH Q3D by ICP-AES
  • Analytical development in the laboratory by ICP-MS or ICP-AES
  • Analytical validation in the laboratory according to the ICH Q2 guideline

The analytical park includes 13 ICPs


How long will the analysis take?

For routine assays, analysis times are between 1 and 10 working days depending on requirements. 


FILAB laboratory is COFRAC ISO 17025 accredited for the following scope: analysis and determination of elemental impurities and minerals including heavy metals by ICP-AES and ICP-MS in cosmetic and pharmaceutical products according to the European Pharmacopoeia 2.4.20 and USP 233.

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