I find this an interesting idea, as I would have though that the temperatures involved in hot melt extrusion would have caused higher levels of nitrosamine formation - though is there loss of NDMA at those elevated temperatures (evaporation)?
The synopsis mentions measurement by GC, not GC-MS - is the methodology sensitive enough?
Unfortunately I won’t be able to attend, but it would be great to hear from anyone who does.
I also am intrigued Mark, as you suggest, the higher temperatures should be expected to drive formation but as you say should also remove NDMA and DMA? This does seem contrary to some of the the discussions within IQ back in 2021, but it would be good to understand more. I would not see simple GC-FID as sensitive enough, without adding preconcentration etc. NPD detection may work but there is also a lot of Nitrogen in your typical Metformin sample. As a reference for the end to end risk, and control strategies for Metformin and NDMA the Schlingemann paper from Merck KGaA in 2022, https://www.sciencedirect.com/science/article/pii/S0378517322002952 -Avoiding N-nitrosodimethylamine formation in metformin pharmaceuticals by limiting dimethylamine and nitrite