Extractables and Leachables Testing
Advinus has a rich history of over 25 years and a track record of developing 50 INDs and over 8500 regulatory studies for global regulatory submission by sponsors world wide. In our constant effort to better ourselves and extend the gamut of services we offer, we are happy to announce the availability of Extractables and Leachables testing.
Extractables and Leachables (E/L) studies are critical to the identification and quantification of potentially harmful impurities which could migrate from pharmaceutical container closure systems, process equipment and packaging to contaminate pharmaceutical products. For assessment of any risks associated with the leachable impurities, it is imperative that E/L studies are designed specifically for your drug product and the container materials.