Elemental impurity analysis according to ICH Q3D in the laboratory
Your needs: Actors in the pharmaceutical field, you wish to analyze 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 analyze 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 30 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:
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
Elemental impurities analysis is an important process in ensuring the safety and efficacy of pharmaceutical products. The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) has established guidelines for evaluating and controlling the presence of elemental impurities in drug products, known as ICH Q3D.
There are various analytical techniques that can be employed to detect and quantify these impurities, including :
- atomic absorption spectroscopy,
- inductively coupled plasma mass spectrometry,
- X-ray fluorescence spectroscopy.
These methods allow for precise measurements of elemental impurities. By using these techniques, pharmaceutical companies can ensure that their products meet the stringent safety requirements set forth by regulatory agencies.
- Evaluation of toxicology data for each potential elemental impurity.
- Calculation of the Permitted Daily Exposure (PDE), which is the acceptable daily exposure level for the user, for each impurity.
- Risk analysis to monitor and control elemental impurities.
There are regular modifications on the guideline for elemental impurities, and the latest version was adopted on 26 April 2022 with Q3D(R2). The main changes about ich q3d 2022 concern:
- Correction on the Permitted Daily Exposure for gold, silver and nickel, and monographs for the gold and silver
- Limits for Elemental Impurities by the Cutaneous and Transcutaneous Route
Cadmium, Arsenic, Mercury, Cobalt, Nickel, Thallium, Gold, Iridium, Rhodium, Silver, Platinum, Lithium, Barium, Copper, Chromium…
