Identification of detected extractables or leachables in concentrations above the applicable toxicological threshold is a vital part in the interpretation of non-targeted screening data, usually obtained by chromatography – mass spectrometry. A correct identification is a key aspect for the toxicological assessment, since the toxic potential of a compound is directly linked to its chemical structure. Assigning a wrong identity inevitably leads to a flawed toxicological assessment, where in a worst-case the safety for the patient may be at risk. Adherence to good identification practices should mitigate the risk of securing incorrect identifications. In this presentation our suggested good identification practices will be explained in more detail. Additionally, strategies to upgrade the identification level of reported compounds will be discussed.
Dr. Ward D’Autry, Study Director – Nelson Labs
