We need your help!! As part of an internal initiative with the USP Nitrosamines team, I’m reaching out to you—our trusted community—to help identify those nitrosamine impurities that are giving you a hard time.
Are there specific nitrosamines or related impurities for which you’ve struggled to access reliable reference materials?
Have you encountered obstacles in synthesizing or sourcing a particular compound for your testing or confirmatory work?
We want to hear from you! Your insights can directly inform our prioritization efforts and guide USP in filling critical gaps for the scientific and regulatory community.
To protect your confidentiality, please use the “Anonymous” post button when sharing. No challenge is too small, and every bit of feedback helps.
Thank you for supporting this mission!
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I thought this would wake up interest in our community! The desire to understand and identify impurities that are impossible to synthesize seems not to be a priority? — or if you prefer email me directly to ner@usp.org
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The fact that in the EMA list of acceptance intakes, is still presented the N-nitrosoticagrelor should have made this topic as a high priority.
‘‘False’’ standard references could lead to false results, rejections of submissions or even recalls of final products.
Thanks for highlighting this Naiffer,
Christos
EMA and USFDA have just published the risk of formation of N-nitroso-impurity, its us who need to justify and both agencies accept the technical justification. Yes, now is the time that all regulatory agencies should update the list based on the technical inputs from industry, The fact is N-nitroso Ticagrelor will not form. The reaction will undergo rearrangement to form another impurity.
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Hi all,
There is one impurity i know is N-Nitroso Felodipine impurity which is hard to systhesis in lab and found unstable in lab.
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Hello,
I find hard sometimes to find the standards but usually I canmanage it, until now. However, what makes me a little bit concerned, is that some suppliers that already have the compound available are quoting the justification report. So that the moment I am not sure of the quality of the justification report and all the syntesis attempts described in it.
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Pls check NMR carefully, its one of most authentic tool to identify if the impurity is correct. Pls do consider chemical shifts carefully.
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