@Nitesh interesting you flagging the control of Nitrosamine in carriers like water. My team knows anecdotally that there is a lot of nitrosamine testing going among India’s manufacturers is in water. Although we have not been pointed out to specific cases where water is the main source of Nitrosamines, it raises my curiosity as to why so many manufacturers testing their water. Regarding solvents, I am aware of control strategies been deployed at API manufacturers.
Maybe @Aaron @nathananderson or @ShoheiSawada might share any insight from their perspective related to water/solvent level of analytical workload happening.
@MichaelBurns @David do you think we coordinate a presentation to discuss the work that Lhasa is leading on Nitrates excipient content database.
This thread on excipients shines some light on this topic. In there @Yosukemino shared an example presented by Dr. Urquhart, where the “worst case” scenario was calculated for a formulation assuming 100% conversion on Nitrosamines.