Mark Jordi has published a series of articles on use of multiple detectors (LC-UV,LC-CAD, GC-FID, GC-MS, LC-MS) as a mechanism to ensure correct relative response factors are used in extractable screening studies as an alternative to very high uncertainty values in setting AETs.
What do people think of this approach?
I am interested in hearing why people choose the solvents they do for their extraction studies. Anybody care to share what they would recommend and why?
Do you think all methods for Extractable and Leachable methods need validation? Can you successfully validate a method without reference standards? How do you test the accuracy of your methods?
As per the name. Come here to post and ask questions about anything around E&L. There no such thing as a stupid question.
It those simple questions that sometimes lead to the most profound discussion. For example, what is an extractable?
We have so many different descriptions for at the moment. It a very open question and the correct answer is all about the context in which it is asked. I think the simplest answer is it is a designed experiment to determine what is present in the sample (typically a component material of a system) which you want to establish identity and amount.
Comments are most welcome
I am starting to get the feeling that even for lifecycle management changes, the FDA are requiring a leachable study. As the PQRI/USP guidelines state that you must perform a leachable study on pMDI's, it doesnt seem to leave any room for interpretation. My personal view on this (from a beginners perspective) is
1) Perform a leachable study regardless (even if considered safe by toxicologist) to show correlation. This in a sense "validates" your controlled extraction study.
2) Perform a leachable scanning study to identify actual leachables and then perform quantification.
3) Pick known additives of concern from supplier and monitor through shelf life.
I was hoping that implementation of ICH Q3E guidelines might mean that we could keep a "dossier" on the container closure system, so that enforced changes can be risk assessed and mitigate need tor leachables (but only when considered low risk by toxicologist).
Thanks again for you help and for setting up this forum. As highlighted by the JPAG meeting, there are different interpretations of the guidelines so discussing in an open forum is really beneficial.
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What is the forum view on method performance testing for E&L. I have used test mixes in the past for system suitability check? I think they are very valuable for any trace analysis method. Do others agree?