Elemental impurity analysis according to ICH Q3D in the laboratory

Your needs: Actors in the pharmaceutical field, you wish to analyse the elemental impurities in your products according to ICH Q3D

What is ICH Q3D?

The ICH (International Conference on Harmonisation) Q3D guideline establishes the methodology for the assessment of elemental impurities in pharmaceutical products, including medicinal products for human use.

The ICH Q3D also reports 4 classes of elemental impurities, including heavy metals, according to their toxicological impact and potential presence in the pharmaceutical product.

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

Why analyse elemental impurities according to ICH Q3D?

The analysis of elemental impurities according to ICH Q3D allows first of all to verify the non-toxicity of your products. Indeed, heavy metals are particularly dangerous for health and are strictly regulated.

Moreover, the ICH Q3D directive has been applicable since June 2016 to new applications for Marketing Authorisation (MA), and in January 2018 for medicines already on the market.

Thus, the analysis of elemental impurities according to ICH Q3D is essential for the marketing of your products.

Elemental impurity testing according to the ICH Q3D directive: a FILAB laboratory speciality

For more than 20 years, FILAB has been providing elemental impurity analysis services to dozens of clients according to ICH Q3D, some of them under COFRAC ISO 17025 accreditation.

Thanks to its state-of-the-art analytical equipment (12 ICP-MS and ICP-AES, 1 mercury amalgamator with autosampler, plate or microwave mineralisation techniques) and its high level of expertise in elemental analysis, FILAB offers you its elemental impurity analysis services to meet the requirements of the ICH Q3D Directive:

  • Analytical laboratory development by ICP-MS or ICP-AES

  • ICH Q3D Analytical Training

  • Analysis of heavy metals and elemental impurities ICH Q3D by ICP-MS

Did you know that?

FILAB laboratory is COFRAC ISO 17025 accredited on the following scope since 2015: Analysis and determination of elemental impurities and minerals including heavy metals by ICP-AES and ICP-MS in cosmetic and pharmaceutical products according to European Pharmacopoeia 2.4.20 and USP 233

The positive aspects of FILAB

  • A highly qualified team

  • Responsiveness in responding to and processing requests

  • A complete analytical park of 2100m²

  • Tailor-made support

Caroline KURZAWA R&D Project Engineer
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