Recent product recalls due to the unexpected presence of N-Nitrosamines have highlighted the critical need to understand the formation of these amines in materials commonly used in the primary packaging of drug products. This presentation at the 2022 Nelson Labs Virtual Symposium will delve into the complexities of N-Nitrosamine formation and the implications for the pharmaceutical industry.
The key question to be addressed is whether we fully understand the materials of construction of container closure systems and their potential to generate N-Nitrosamines. It is well-known that secondary amines (and potentially tertiary amines) are precursors to N-Nitrosamine formation. These compounds must be considered when evaluating the extraction profile of packaging materials to ensure product safety.
The presentation will explore whether the presence of these amine precursors should raise a “red flag” in an N-Nitrosamine risk mitigation strategy. Attendees will gain insights into the scientific and regulatory perspectives on this issue, learning how to identify and assess the risk factors associated with N-Nitrosamine formation in primary packaging materials.
Participants will be guided through the process of evaluating materials of construction for their potential to form N-Nitrosamines. This includes understanding the chemical interactions that lead to their formation and the methodologies for detecting and quantifying these impurities. The session will also cover the regulatory expectations and best practices for incorporating these considerations into a robust risk mitigation strategy.
By attending this webinar, professionals involved in the development, manufacturing, and quality assurance of pharmaceutical products will gain valuable knowledge on managing the risks associated with N-Nitrosamines. This will help ensure the safety and compliance of their products, ultimately protecting patient health and maintaining regulatory approval.