ICH Q3D analysis in the medical industry

Medical industry, you want to perform an analysis according to ICH Q3D

What is ICH Q3D?

Firstly, the ICH (International Conference on Harmonisation) Q3D guideline indicates the methodology for the assessment of elemental impurities in pharmaceutical products.

The ICH Q3D stipulates 4 classes of elemental impurities, including heavy metals, according to their toxicological impact and their 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 perform an ICH Q3D analysis?

Heavy metals are particularly hazardous to health and are strictly regulated.

Therefore, the analysis of elemental impurities according to ICH Q3D allows to verify the non-toxicity of your products. Therefore, the analysis of elemental impurities according to ICH Q3D by a competent laboratory is indispensable for the marketing of your products from the medical industry.

FILAB supports you in your analysis needs according to ICH Q3D

Through our three levels of services: analysis, expertise and R&D support, FILAB assists companies in the medical industry with their analysis needs according to ICH Q3D. FILAB provides its clients with the know-how and experience of its team, as well as a 2100m² analytical park equipped with state-of-the-art equipment. 

our services

  • Analytical laboratory development by ICP-MS or ICP-AES
  • Heavy Metals Analysis and Determination
  • ICH Q3D Analytical Training
  • Determination of heavy metals according to ISO 21392:2021

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

Thank you !

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