Elemental impurity analysis
according to ICH Q3D
ICH Q3D is a methodology for assessing elemental impurities in pharmaceutical products. This guideline has been in force since June 2016 for new applications for Marketing Authorization (MA) of drugs for human use.
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...
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.
Why FILAB?
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.