Control Strategies And Method Development For Nitrosamines In Peptide APIs And Drug Products

By Marc Jacob, Aaron Catledge, Daniel Pazo, Ben Singh, and Shankar Sankaran

The poster discusses strategies for controlling and detecting nitrosamines in peptide APIs and drug products. It emphasizes the need for sensitive testing methods due to low acceptable intake limits set by regulatory agencies like the FDA and EMA. Key methods for nitrosamine detection include GC-MS and LC-MS/MS, which are crucial for meeting stringent impurity limits.

Readers will also find highlighted challenges such as matrix-related interference and co-elution issues with APIs, which complicate recovery rates. Case studies demonstrate the effectiveness of orthogonal methods, such as using different columns for LC-MS and employing GC-MS for improved nitrosamine detection in specific cases. It also addresses the need for platform methods to expedite method validation and testing. The importance of robust screening processes and the development of reliable extraction techniques is underlined, with detailed examples showcasing the role of high-resolution mass spectrometry in identifying and quantifying drug-derived nitrosamines.

Uncover why collaborative efforts are a crucial necessity in refining testing methods to ensure the safety and compliance of peptide-based drugs by downloading the poster below.