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on-demand Webinar

Unmasking the unknown: how mass spectrometry delivers accurate identifications

In this webinar, learn more about advanced techniques like mass spectrometry which can help identify unexpected impurities in drug substances and drug products.

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

High-resolution accurate mass spectrometry combined with tandem mass spectrometry 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 presentation, 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

 

OUR SPEAKER

Ruud CuyversRuud Cuyvers – Senior Expert LC/MS

As a key member of the Structure Elucidation Team, Ruud Cuyvers focuses on identifying unknowns in HRAM screening projects and unknown impurities in drug products or drug substances. Ruud also drives scientific innovation at Nelson Labs by working on the development and implementation of new analytical solutions. He joined Nelson Labs in 2013 as a liquid chromatography specialist. Over the years, his technical expertise in chromatography and mass spectrometry has been vital for the E&L testing services of the company.

FAQs

FAQs 

Is the webinar free? 

Yes – there is no charge to watch the webinar, either live or on-demand. 

When will the webinar take place? 

2 October 2024 at 3.00pm GMT. 

Can I watch it later? 

The webinar will become available to watch on-demand shortly after the live webinar takes place. 

What are the benefits of attending live? 

You’ll be able to ask the speakers your questions, which will be answered live in the Q&A towards the end of the session. 

How long will the webinar be? 

This webinar will last up to an hour. 

What do I need to watch this webinar? 

All you need is a computer with an internet connection. We recommend using headphones if possible if you’re in an office environment.