ICH Q3D analysis by ICP in the laboratory

You wish to perform an analysis according to ICH Q3D by ICP

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 by ICP?

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

ICP, short for “Inductively Coupled Plasma“, is an inductively coupled plasma analytical technique for measuring the content of an inorganic element in a sample. This technique is applicable to all types of chemical elements.

Therefore, the analysis of elemental impurities by ICP according to ICH Q3D allows to verify the non-toxicity of your products. Thus, the analysis of elemental impurities by ICP according to ICH Q3D is essential for the marketing of your products.

FILAB supports you in your ICH Q3D analysis needs by ICP

Through our three levels of services: analysis, expertise and R&D support, FILAB assists companies from all sectors in their ICP 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. The combination of ICP-AES and ICP-MS allows the determination of a wide range of inorganic elements and elemental impurities, in a single run, with extreme reliability and accuracy (from ppt to ppb depending on the matrices).

FILAB laboratory is COFRAC ISO 17025 accredited for the following competence 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

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

Caroline KURZAWA
Caroline KURZAWA R&D Project Engineer
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