EXTRACTABLE AND LEACHABLE IMPURITIES
Prevent health risks caused by toxicological properties of packaging and manufacturing materials.
Materials used in pharmaceutical packaging or in the manufacturing process can migrate to a finished pharmaceutical product. This might change the product’s composition, followed by changes in therapeutic action, organoleptic properties, or stability – and a serious health risk due to the toxicological properties of the materials.
It is therefore essential to determine which materials are compatible with your product to not only comply with all regulations, but also to guarantee patient safety.
There are two types to be regarded here. Extractables are the compounds that can be extracted from a material under forced laboratory conditions. They typically represent the worst that could happen under extreme circumstances. Leachables, on the other hand, are components that migrate into the product under normal application and storage conditions, as well.
We both conduct complete studies of extractable substances and develop methods to monitor the presence of leachables in your final product to identify and address all risks.
To ensure the highest standards, we work in GMP and FDA certified analytical laboratories that have the technology to detect ultra-trace levels. Our team of expert toxicologists accredited by AETOX and EUROTOX customizes everything to your specific needs.
Our service for extractable and leachable impurities includes:
- Review of all materials used in packaging and production, production procedure and equipment to predict the compatibility of your packaging system with your product: we specify each material and study its condition during all steps of the manufacturing and storage process.
- Extraction studies on the materials: In order to see how they react under extreme conditions, we design and carry out a specific study for each material.
- Leachable studies: We identify any volatile and semi-volatile impurity derived from the given materials that may be found in the final product under normal conditions of use.
- Toxicological evaluation of the detected impurities: We define the toxicological profile of the impurities and the risk they pose for the patients, using literature reviews, data migration via the read-across technique, and QSAR methods to predict toxicological end points. This way, we can define safety limits and adjust them for different forms of medication application.
- Toxicological risk analysis: Considering the results of the extraction studies and the inherent toxicology of each extractable, we assess the risk posed by different exposure levels to the impurity in the finished product.
- A detailed report of findings in accordance with the applicable legislation (FDA, EMA, PQRI, PDA).