Mérieux NutriSciences has a proven track record in carrying out studies of extractables and leachables in order to detect very low levels of contaminants from materials in contact with medicinal products and medical devices.
Mérieux NutriSciences provides analytical support for:
- Development of analytical study plans for determination of extractables and leachables
- Profiling of extractables
- Characterization of extractables
- Research into organic compounds using TOC, HPLC-UV/DAD, HPLC-ELSD, LC-MS/MS, LC-Q-Orbitrap and GC-MS
- Research into elemental impurities using AA, ICP-OES or ICP-MS
- Development and validation of methods suitable for the quantification of specific leachables present in the drug matrix, based on the extractables studies