As a pharmaceutical manufacturer, you would like to carry out an ICH Q3E analysis
ICH Q3E
The ICH Q3E (International Conference on Harmonization) guideline establishes principles and methodologies for the assessment and control of extractable and leachable impurities in medicinal products.
It aims to ensure product safety and quality by ensuring that substances from packaging materials or closure systems do not contaminate the final product.
FILAB carries out your analysis in compliance with the ICH Q3E guideline, using cutting-edge analytical equipment
Why choose FILAB for ICH Q3E analysis of your drugs?
For over 30 years, the FILAB laboratory has been providing dozens of customers with elemental impurity analysis services in accordance with USP 233, ICH Q3D and ICH Q3E, some of which are COFRAC ISO 17025 accredited.
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 skills in elemental analysis and pharmaceutical analysis, the FILAB laboratory offers you its elemental impurity analysis services to meet the requirements of USP 233:
ICH Q3D and ICH Q3E: two complementary standards mastered by FILAB
ICH Q3E : Extractibles and Leachables
This more recent directive, currently undergoing harmonization, was created to manage substances that can migrate from direct contact materials (such as vials, caps, syringes) into the drug itself. These substances are generally organic compounds that degrade or are released from the packaging material.
ICH Q3D: Elemental Impurities
The ICH Q3D guideline aims to control and limit the presence of elements such as lead (Pb), mercury (Hg), arsenic (As), and cadmium (Cd) in pharmaceutical products. These elements can be present in trace amounts in raw materials, excipients, catalysts, or even migrate from production equipment.
Technical means used for ICH Q3E analysis
- GC-MS, HPLC, or UHPLC/MS/MS for the detection, identification, and quantification of organic compounds present in solvents, UV-protective material additives, antioxidants, dyes, inks, detergent residues, sterilization residues, polymer residues, etc., which have been extracted and/or released from the material by a standardized simulant.
- UV-visible spectrophotometry for the determination of Chromium VI released by metal alloy materials.
- ICP-AES and ICP-MS are particularly suitable for mineral or metallic pollution or additives, such as heavy metals, mineral or metallic fillers, dyes, etc.
- SEM-EDX microscopy, a truly rapid and versatile diagnostic tool for diagnosing the surface condition of the material after aging, and observing particles and deposits.
Our other extractable and leachable analysis services
FAQ
Extractables and leachables analysis is a process of assessing and controlling the migration of chemical substances from packaging or manufacturing materials into a pharmaceutical product. The objective is to ensure that these substances, even at trace levels, do not compromise the safety, quality, or efficacy of the drug.
- Extractables are compounds that can be extracted from a material using harsh solvents and high temperatures. Extractables analysis aims to identify as many of the chemical substances that make up a material as possible.
- Leachables are compounds that actually migrate from the material to the finished product under normal use and storage conditions. Leachables are generally a subset of extractables.
The ICH Q3E is a guideline that harmonizes regulatory requirements worldwide (Europe, USA, Japan, etc.) for E&L studies. Its importance is paramount for the pharmaceutical industry because it:
- Ensures patient safety by limiting exposure to contaminants.
- Simplifies the new drug submission process by providing a single framework for safety studies.
- Eliminates the need to repeat analysis for each region of the world.
The directive applies to all materials that come into direct contact with a pharmaceutical product. This includes:
- Primary packaging systems (vials, pre-filled syringes, intravenous bags).
- Closure systems (caps, seals).
- Single-use production equipment (filters, tubing).
- Medical devices that administer a drug (inhalers, catheters).
