Secondary amine Risk Assessment

[JohannesReiner]

Thank you for the feedback, maybe this thread is also supporting you

Testing and controls for nitrosamines for components of container closure systems

What level of testing and controls for nitrosamines are expected for components of container closure systems, for example rubber stoppers?

There is also an interesting paper from BettineBoltres

Testing and controls for nitrosamines for components of container closure systems

Just as an fyi and for those who are interested: My paper on nitrosamines from elastomers has been accepted by PDA Journal of Pharm Science & Technology: Evaluating Nitrosamines from Elastomers in Pharmaceutical Primary Packaging | PDA Journal of Pharmaceutical Science and Technology Maybe this also helps a little bit to understand the background of nitrosamines from elastomers.

All the best