Toxicological risk assessment of extractable and leachable impurities

At Netpharmalab we recognize the duality of pharmaceutical and biopharmaceutical containers and delivery systems: on the one hand, they protect against environmental contamination, on the other, they can be potential sources of contamination. This reality extends to polymeric materials and plastic components used in the manufacture of medical devices, which can pose a risk due to the possible migration of compounds, impurities and additives to the product.

To address these challenges, our controlled extraction studies are designed to identify and quantify extractable impurities that could migrate from polymeric materials to pharmaceutical products under extreme conditions. Following this, we perform a toxicological risk analysis to determine the actual presence of each extractable in the maximum dose of the product.

With the results obtained from the toxicological risk analysis and always considering the type of product, we carry out leachable studies. These studies are crucial to evaluate the presence of leachable impurities in the final product, ensuring both product quality and patient safety.

Our commitment

At Netpharmalab we not only have the advanced equipment necessary for Extractables and Leachable studies, but we also have a team of experienced professionals and highly qualified toxicologists. We are dedicated to conducting accurate and detailed evaluations, ensuring safety and compliance with the highest quality standards.

Contact our team of experts in studies of extractable and leachable impurities in pharmaceutical products to ask any questions or request more information about our services.