Your needs: carrying out an analysis of extractables and leachables according to ICH
Extractables and leachables
Studies on extractables and leachables examine the interactions between pharmaceutical products and their packaging. These interactions can occur at various stages, from the production process to the product’s shelf life. While packaging is essential for ensuring the safe storage and/or administration of products, it can sometimes negatively impact the product due to the migration or transfer of certain substances. To minimize migration and protect consumers, packaging must comply with strict standards and regulations.
Why study extractables and leachables according to ICH?
To determine migration levels, products must be tested for extractables and leachables. Extractable compounds are those that can be drawn out of a regulated product when exposed to certain solvents under specific conditions. In contrast, leachable compounds are those that can migrate from a product’s formulation under normal use. These contaminants pose toxicological risks and can accelerate product degradation, especially in biopharmaceuticals.
Pharmaceutical packaging, bioprocess materials, drug delivery systems, and implantable medical devices are often complex in composition. They may consist of a combination of plastics, polymers, rubber, glass, printed materials, and coatings. Consequently, extractables and leachables studies must be tailored to the unique characteristics of each product to ensure accurate and reliable assessments.
FILAB supports you in the analysis of extractables and leachables according to the ich
At the Filab laboratory, we provide you with advanced expertise and state-of-the-art analytical equipment to help you identify, quantify and assess the risks associated with extractables and leachables in accordance with ICH requirements.
Why are E&L analysis according ICH essential?
Analysis of extractables and leachables are crucial for guaranteeing :
- Regulatory compliance: meeting the requirements of agencies such as the EMA, FDA and ISO.
- User safety: identification and quantification of potentially toxic compounds.
- Product quality: prevention of undesirable interactions between materials and formulations.
Our technical resources for extractables and leachables analysis according to the ich
No single analytical technique can detect all categories of compounds in E&L studies. The choice of techniques depends on the specific product and its packaging components. As a result, a combination of complementary analytical methods is used to ensure comprehensive testing.
