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N-Nitrosamines in Primary Packaging for SVP’s

Published Date: September 7, 2022

Because of recent product recalls due to the unexpected presence of N-Nitrosamines, it is important to look at the formation of these amines on materials prominently used in the primary packaging of drug products.

The unanswered question is: do we know everything about the materials of construction of a container closure system and their ability to generate N-Nitrosamines? It is commonly known that secondary amines (and potentially tertiary amines) are a precursor to N-Nitrosamine formation and that these need to be taken into consideration when evaluating the
extraction pro file of materials of construction. The question however remains: should this raise a “red flag” in an N-Nitrosamine risk mitigation strategy?

Learn more about the presenter below.

Ward d’Autry

Ward d’Autry PhD

Study Director Structural Elucidation- Nelson Labs

Dr. D’Autry received his PhD from the Laboratory for Pharmaceutical Analysis, Faculty of Pharmaceutical Sciences of the University of Leuven (Belgium) in 2010. From 2010 to 2017 he worked for DSM and SABIC in Geleen, The Netherlands, where he worked as an R&D scientist developing and optimizing chromatography & mass spectrometry based analytical methods for improved analysis of (complex) petrochemical samples or polymeric systems. Often his work included interpretation of mass spectral data. Since 2017 Dr. d’Autry has worked for Nelson Labs Europe as study director extractables & leachables. In this current role, he manages extractables & leachables studies with focus on manufacturing components. In 2021 he took up a new role as study director structural elucidation, where he manages second-pass identification studies.

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