We Japanese pharmaceutical companies had a discussion to share knowledge related to the risk assessment of nitrosamines at the beginning of March, and we found generic pharmaceutical companies suffered from the lack of NDSRIs standards. The synthesis of NDSRIs brings lots of helpful information for risk assessment, but most generic providers in Japan are not likely to own a chemical synthesis department. Some companies could get the NDSRI samples from vendors, but others not, even though they tried hard to look for vendors accepting the synthesis of NDSRIs. What should we do to get the NDSRI samples unless in-house chemical synthesis groups are available? Are there any contract labs to synthesize NDSRIs? I think this is not a rare case. I would appreciate it if you could give me your opinions or share your experiences, @Naiffer_Host, @ASrinivasan, @DAB, @conudel, @Diego_HM, @AndyTeasdale, and others.
@Yosukemino depending on the type of NDSRIs in need, I can connect our USP Nitrosamines in charge of development of Analytical Impurities.
Do we have a list of candidates? @Mrunal@Zeenat@levelchange
What I could tell is that NDSRI are commercially available or by demand, but needs to be sourced from abroad in my case.
What is important is that the standard has all the neccesary documentation to give reliable results (characterized with several techniques, etc.).
Additionally, I didnt know about the possiblity to look into USP support for getting nitrosamines standards, so would be interesting to get in touch with Naiffer and his/her colleagues.
Thank you for sharing helpful information, @Naiffer_Host and @Diego_HM. I am interested in the USP project related to NDSRI standards. I am going to suggest generic pharmaceutical companies look for NDSRI providers abroad. And I will keep in mind to carefully review necessary documents such as the elucidation of the structure, certificates, and handling manuals. A testing method is also available in some cases. It’s helpful.
I can help you connect with vendor in India for NDSRI impurity who are being used by our customers when they send NDSRI projects to us for method development and validation.
I am reachable on ashay.mehta@dalpl.co.in
If you are thinking about contract synthesis of NDSRIs, I would look for laboratories specializing in working with highly toxic substances, adapted to work with the OEB-6 class of carcinogens. Of course, it will be expensive, but outsourcing such syntheses to small companies unaware of the threat is heartless.
