When we first launched Nitrosamine Exchange, we originally tackled discussions related to risk assessment, a topic that continues to be of a lot of uncertainties and gaps. Our core goal is to close those gaps and clear some of those uncertainties by sharing information, knowledge, common challenges, discussions, or simply a place to ask questions when one is stuck!
We also know the journey does not stop there, ‘Confirmatory Testing’ is next, and it comes with its own challenges. With that, I wonder myself:
Does it make sense to open discussion in the community related to analytical challenges?
How can we maintain a rail guard in our discussion, so it does not become a place to market brands or products?
If we open the community in that direction, What specific expectation would you have?
We would appreciate your feedback by replying here.
I would like to know how well labs are able to meet the LOQ requirements, especially for complex products with large maximum daily doses like creams and ointments. What sample preparation techniques work for them? What doesn’t work so well?
Yes, I agree for including Analytical testing of Nitrosamines in discussion. As most of have faced challenges on analysis and need more clarity on assessment of Nitrosamines in drug product and drug substance.
In similar groups there is a filter previous to any publication to warrantee the scientific and not commercial focus of the post.
A heavy measure can be ban any single post from vendors… and if we want to communicate with someone do it in private if possible.
I am not directly involved in analytical testing, so I can’t contribute specifics or tipps and tricks, but yes, I think it would be relevant. As we are talking very low concentrations here, there are so many obstacles / interactions, matrix effects, preparation influence, and things to care of in order to obtain solid results, I think it is useful have a platform where analysts can exchange on their challenges.
Challenges around analytical testing will go down two potential paths. Can I do this testing in large numbers or can I just analyse it in very complex matrices (ointments & gels as someone has mentioned). This will probably need automation for the first part and with the complex matrices some “interesting” sample prep and recovery will be required.
Hi Naiffer @Naiffer_Host
Thanks for thinking about this, sharing my thoughts,
It’s a good idea to include discussion on Analytical challenges too since there are members in the community from the Analytical fraternity, myself included and having accurate sensitive Analytical methods and emerging Technologies is a challenge that Analytical scientists have been facing and are working upon.
Having said that the discussions could be focussed on knowledge sharing on Science n Technology instead of brands .
Hope this will help the community.
I also agree. In case confirmatory testing for products with a higher maximum daily dose to reach the recommended LoQ /LoD will be very challenging or even unrealistic considering the current technologies. I would also like to additonally open a new categroy related to in silico methods related to determination of the carcinogenety/genotoxic properties of Nitrosamines under investigation. I guess we have in our community memebers from LHASA and they have a very good webinar on this topic. Since not all Nitrosamines seems to have carcinogenety/genotoxic properties maybe such an evaluation can reduce analytical efforts significantly. Here what would be very interesting is the acceptance of such an approach of authorities since this is not an official option in the respective EMA/FDA publications.
I also agree. In my opinion, analytical issues have lots of problems specific for structure of nitrosamines, features of API and drug products, including sample preparations, improvement of sensitivity, mitigation of false positive signals, routine tests vs option4, reference standards… To be honest, I have no idea how to share them appropriately, however I believe we can start discussion whenever we want.
The following thread may be similar to your suggestion. And I agree with your thought, both are definitely important!!
Hi everyone, I echo these comments and concerns and the need to expand the analytical science discussions. There is a huge amount of cross industry learning on the analytical methodology that we can share. Of particular importance is the risk and sources of artefactual formation and how this can be avoided. Two key channels that will help us share learning are the many forums and conferences that are covering nitrosamine trace analysis and also peer reviewed journal articles. For the latter, I expect many to be available over the coming months.
Good Afternoon everybody! I happy to announce that we have received internal approval to go ahead and expand our Nitrosamine Exchange to include 'Analytical Challenges Discussions". Please read the Category description for details and rules of engagement in this topic. As always we will rely on your the community members to help build and stir the conversation in this important topic.
Each of your feedback and comments were consider in our internal approval process.