ICH Q3D Testing - Elemental Impurity Analysis Laboratory
ICH Q3D : Test your products for elemental impurities
Ensure your pharmaceutical products comply with the ICH Q3D guidelines on elemental impurities with FILAB’s expert testing services.
As a COFRAC ISO 17025 accredited laboratory, FILAB provides fast and reliable ICH Q3D testing using state-of-the-art techniques (ICP-MS, ICP-OES). Whether you are launching a new drug product or performing routine compliance tests, our scientific team supports you from method development to result interpretation.
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.
ICH Q3D testing : Our analytical capabilities
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.
FILAB offers comprehensive elemental impurity testing according to ICH Q3D through:
- ICP-MS (Inductively Coupled Plasma Mass Spectrometry). Ultra-trace quantification of Class 1 and 2 elements
- ICP-OES (Optical Emission Spectrometry). Cost-effective detection of Class 3 elements
- Full validation or verification protocols
- Custom testing methods tailored to your matrices (API, excipients, final products)
We help you determine which elements apply to your formulation and perform risk assessments where needed.
The elementary impurity classes described by ICH Q3D
Under ICH Q3D, elemental impurities to be analyzed primarily include heavy metals and other toxic elements. Impurities are classified based on their toxicological impact and potential presence in the pharmaceutical product.
- Category 1: Arsenic (As), Cadmium (Cd), Mercury (Hg), Lead (Pb)
- Category 2A: Cobalt (Co), Nickel (Ni), Vanadium (V)
- Category 2B: Silver (Ag), Gold (Au), Palladium (Pd), Iridium (Ir), Osmium (Os), Rhodium (Rh), Ruthenium (Ru), Selenium (Se), Thallium (Tl)
- Catégorie 3 : Ba (Baryum), Cr (Chrome), Cu (Cuivre), Li (Lithium), Mo (Molybdène), Sb (Antimoine), Sn (Étain)
FILAB laboraties : an accredited expertise since 2015
Since 2015, FILAB has been COFRAC ISO 17025 accredited for the analysis and quantification of elemental impurities and minerals, including heavy metals, in cosmetic and pharmaceutical products.
These analyses are performed using ICP-AES and ICP-MS techniques, in compliance with European Pharmacopoeia 2.4.20 and USP standards.
FAQ
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…
The guideline sets Permitted Daily Exposure (PDE) limits for 24 elemental impurities, classified by toxicity and administration route.
APIs, excipients, finished drug products, packaging, process intermediates…
Not necessarily – a risk assessment may exclude irrelevant elements. FILAB assists you in this determination.
