A community member brought to my attention that there is a reference material supplier that is currently offering Synthesis Attempts and Failure Reportsā¦ I know organizations have used these types of reports to justify the derisking of particular nitrosamines. I imagine the depth of this report has to be significant for a regulatory body to accept, including all the characterization and analytical evidence.
I have not seen any of these āfor-purchaseā reports, so I cannot speak on their rigurosity. I wonder if anybody has had experience with these types of off-the-shelf reports.
Dear Naiffer,
is just some days ago that we have asked for this type of a failure report from an impurity supplier.
The draft sample which have been send to us was very nice with a lot of information regarding synthetic trials and identification data.
In this sample it was noticeable that they have also implemented the 3-armed nitrosation based on the paper of I. W. Ashworth et al (Approaches and Considerations for the Investigation and Synthesis of
NāNitrosamine Drug Substance-Related Impurities (NDSRIs). Org. Process Res. Dev. 2023, 27, 1784ā1791.
Here is a part of the content from the sample report (only two out of 10 synthetic trials is presented here)
I didnāt want to be seen advertising any particular company on LinkedIn - it shouldnāt have taken a lot for people to have been able to find who was offering this service for themselves.
I donāt know if this is from the company I had seen, but it looks a promising, positive start.