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?
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