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Packaging related nitrosamines in Drug Products

Published Date: September 22, 2023

Join this webinar to learn how to gain insight in nitrosamines impurities, especially nitrosamines related to packaging.

Key Takeaways

  • Case studies will be presented where Extractables screening of primary and secondary packaging materials could assist in the risk evaluation/assessment for the presence of nitrosamines in the related Drug Products.
  • Case studies of Leachables screening in Drug Products will be presented to demonstrate their assistance in the risk evaluation/assessment for the presence of nitrosamines in the concerned Drug Products.

More Information

For many years it has been known that Pharmaceutical Elastomers are the potential source of the existence of nitrosamines in Drug Products. With the recent regulatory spotlight on nitrosamines, other Pharmaceutical packaging constituents came into the picture.

In the subsequent confirmatory testing steps, the following questions need to be answered: are the predicted nitrosamines actually present in the final Drug Product and, if so, do they exceed the acceptable intake limit as listed in the relevant regulatory guidelines? Analytical challenges for monitoring Nitrosamines in final Drug Products will be discussed by means of case studies. In this discussion the focus will be on liquid Drug Products with very high maximum daily doses.


Ank Reumer

Senior Study Director, Quantitative Methods team

Ank Reumer received her Ph.D. from the Faculty of Sciences at the University of Leuven (Belgium). As a PostDoc at the Mass Spectrometry Facility of Leuven, she developed methods for peptide biomarker discovery. In 2014 she started working at Nelson Labs. Currently she is senior Study Director in the Quantitative methods team. The main focus points of this group are method development and validation for evaluation of nitrosamines in Drug Products, as well as in use stability testing of drug-medical device combinations and stability testing of Drug Products.

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