The Extractables & Leachables studies are needed to evaluate the potential release of toxic components from the materials used to the finished product and, ultimately, to the human being (packaging materials for medicines, cosmetics and food, medical devices, materials during manufacturing, etc.).
Plastics, aluminum, rubber and other polymers that are commonly used in the Pharmaceutical, Cosmetic or Food Industry, can release metals, volatile and non-volatile components that can become toxic or harmful to health. Therefore, it is critical to evaluate and control the presence of these components in the finished product to ensure the safety of patients and users.
What is needed for these studies?
In order to carry out these studies, it is necessary to combine several complex techniques that allow the identification of potential metals, volatile components and non-volatile components to be present in the finished product. LC/MS, GC/MS and ICP/MS equipment provide the most complete and accurate assessment.
In addition, it is necessary to be able to make a correct toxicological evaluation of the detected components.
What Netpharmalab offers to you…
At Netpharmalab we have the equipment and the experienced personnel necessary to perform the Extractables and Leachables studies that allow us to make an evaluation and exact quantification of the potential toxic components that may release the materials.
In addition, we have professional toxicologists to perform the toxicological evaluation of those components identified and quantified.