Recent Trends & Regulatory Developments in Mutagenic/Nitrosamine Impurities Analysis

In 2018, several ARB-class drug products were recalled due to the presence of unacceptable levels of mutagenic nitrosamine impurities. Since then, more classes of drugs have been added to the list, newer impurities are being monitored, and regulatory limits for identification and quantification are going down.

Drug manufacturing processes are being evaluated to identify and control the source of contamination in APIs and drug products.

Understanding of this evolving regulatory landscape has become critical for confident analysis and release of the drug product.

What will be discussed:

• Latest regulatory developments for detection and quantification of mutagenic impurities in APIs and drug products
• Learn about newer classes of drugs and mutagenic impurities being monitored by regulatory agencies
• Simplify understanding of current analytical guidelines published by regulatory bodies like USFDA & EMA

Presenter: Chander Mani (Application Specialist, Agilent Technologies, extensive research on nitrosamine applications)