@Yosukemino Thanks for sharing the paper… waiting on my library to send me a copy. Andy does a fantastic job exposing the industry challenges. I’m really interested in reactions from some of the FDA answers to the industry during the joint meeting last May 4th. I would even dare to say that FDA’s strong stand will have a very important effect on emerging regulations from some agencies. At least that has been my reading from discussion with certain regulatory representatives.
@Frabaneda did you chance to review Christopher, @MichaelBurns, Timothy, and Nathan publication. It’s a wonderful insight into reactions that have the potential to destroy the nitrosamine’s moiety. The Nitrosamine chemistry explored is not just fascinating but also a window to how complex it can be.
I would welcome any comment from our organic & medicinal chemist on this.