With so much noise about potential API-specific nitrosamines. I was wondering if anybody in the community knows if it’s a publicly available preliminary assessment of FDA/USP molecules database for secondary amines. If not anybody or the organization willing to collaborate in such an effort? I’m sure we can find resources to conduct such an assessment and make it available… ideas?
Anybody interested on exploring USP/FDA portfolio of molecules for Secondary amines?
Naiffer, I have done this for a client of mine last year itself, where I took the entire list of drugs in USP and put them in buckets - secondary amines, tertiary amines (with risk of NDMA, NDEA), other teritiary amines, quaternary amines with secondary and tertiary amines as impurities. However, I am not at liberty to share this. Also, it good to have this confidential as a company due to legal burden that may come up with it. Someone or some group may start testing specific product to find nitrosamines (like we saw with Metformin) and create tremendous chaos and legal hassle.
Yes, let me know what exactly USP/FDA is focusing on.
@Naiffer_Host would be happy to collaborate. Let me know the way forward
Again, this has been done in 2019 itself. Please understand that this should not be publicized too much as in the hands of wrong people, these could lead to lawsuit after lawsuit.
@AndyTeasdale in reference to your comment:
Desloratadine is unfortunately a secondary amine and thus susceptible to Nitrosation. Somewhere / somehow we have to reconcile the number of drugs that are secondary amines and thus intrinsically at risk with the risk of widespread withdrawals.
Would like to hear your thoughts!
@David @fernandaw @MichaelBurns any interest as part of new Lhasa’s ‘Complex Nitrosamines’ data sharing initiative?