Ahead of the upcoming Extractables & Leachables Asia 2023
conference, we caught up with Dr. Jan Baeten, Sr. Scientist – Technical Advisor
from Nelson Labs Europe
. He gave us a sneak peek of what we can expect from his presentation: 'Selecting the right surrogate standards for semi-quantitative concentration determinations of extractables in GC/MS: what the Nelson Database can learn us'.
Learn more about what he shared with us below!
1. Hi Jan, It’s great to have you joining us this year! Can you tell us more about your upcoming presentation at E&L Asia 2023?
I am also thrilled to present at the upcoming conference. I will talk about aspects of uncertainty and protectiveness when it comes to quantitation as part of the analytical methods used for non-targeted analysis in E&L studies. The main challenges are how to deal with compounds for which you don’t know the response behavior. To tackle this problem, we performed an in-depth analysis of known relative response factors of our Nelson Labs GCMS database and evaluated some new and existing quantitation strategies.
2. Why did you choose to tackle this topic?
From a regulatory perspective, guidance is provided to address the problem of uncertainty when it comes to determining a suitable AET or to calculate protective concentrations. However, there is still some ambiguity of how accurate and how protective analytical methods should and can be, and how the adopted quantitation strategy may influence that.
3. What are the main challenges in your day-to-day work relating to E&L?
As an analytical chemist, I always strive to ensure that the chemical testing procedures we perform day-in-day-out are scientifically sound. A first critical aspect of this are correct identifications which I encounter when reviewing first pass identifications or when performing structural elucidation studies. This aspect cannot be stressed enough because if you picked the wrong identity, then the toxicological risk assessment will be wrong a priori. The second critical aspect is correct quantitations, for which we need a diversified approach depending on the finality of the chemical testing (for instance medical device vs. leachable studies).
4. What are you most looking forward to at the event?
Although I am not able to physically attend the event, I hope of course that my presentation can bring about some fresh insights for the E&L industry. And secondly, an event like this also allows to connect with many people and to learn from the current best practices, challenges and new insights.