In this webinar, presented by our Senior Expert LC/MS, Ruud Cuyvers, you’ll expand your knowledge on unexpected impurities in Drug substances (DS) and drug products (DP).

Drug substances and drug products require continuous monitoring for unexpected impurities to ensure product quality and patient safety. Regulatory guidance provides reporting, identification, and qualification thresholds for impurities, along with acceptance criteria. If during routine quality control a new or previously unidentified impurity exceeds these thresholds, prompt identification becomes crucial.

High-resolution accurate mass spectrometry (HRAM MS) combined with tandem mass spectrometry (MS/MS) is a powerful tool for impurity identification. However, not all compounds responsive to LC/UV exhibit the same responsiveness to LC/MS, especially in the case of leachable impurities. Therefore, the analytical toolbox should extend beyond LC/MS alone.
In this webinar, we will highlight our expertise in this area by presenting case studies where unexpected impurities in drug substances or drug products were identified using a comprehensive mass spectrometry approach.

Key learning points

• Importance of continuous monitoring for unexpected impurities and how to act accordingly.
• High-resolution accurate mass spectrometry (HRAM MS) combined with tandem mass spectrometry (MS/MS) is a powerful tool for precise impurity identification.
• Relying solely on LC/MS for impurity identification may be insufficient. Expanding the analytical toolkit is valuable for comprehensive impurity detection and identification.
• Learn from real-world examples where extensive mass spectrometry approaches can assist in identifying the root causes of unexpected impurities.