Overcoming the Challenges of Nitrosamine Impurities in Drugs

September 10, 2020
Thermo Fisher Scientific

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The low levels at which the nitrosamine impurities occur in pharmaceuticals products creates analytical challenges for accurate determination. In this webinar we will discuss effective GC–MS approaches that provide high selectivity and sensitivity to fulfill the current regulations and enable a broader scope of analysis and future-proof results. Live: Tuesday, Oct. 13, 2020 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST On demand available after final airing until Oct. 13, 2021 Register free

Register free: https://www.chromatographyonline.com/lcgc_w/nitrosamine_impurities

Event Overview:

The challenges for analytical laboratories performing nitrosamine analysis relate to high sensitivity that must be achieved to fulfill the regulation requirements, and selectivity that is critical to avoid false positive non-compliant results. It is essential to analyze nitrosamines that can accidentally occur in pharmaceutical products, because they are carcinogen impurities. The limits imposed by the current regulations are stringent and could potentially be lowered in the future to ensure patients safety. In this webinar, we will discuss the GC-MS approaches that help analytical laboratories to overcome the challenges of nitrosamine analysis. We will look at targeted quantitation using GC-MS and GC-MS/MS coupled with headspace sampling and high-resolution accurate mass using accurate mass confirmation of nitrosamines, allowing expanded scope of analysis and retrospective analysis of samples.

Key Learning Objectives:

  • Overview of nitrosamine impurities and the risk to human health
  • U.S. FDA current regulations for nitrosamine analysis
  • Targeted approach for nitrosamine analysis according to U.S. FDA methods
  • Untargeted approach for the determination of nitrosamines and other volatile impurities with GC­–high-resolution MS and headspace sampling

Speakers: 

Riccardino Giulia, Senior Applications Specialist, Thermo Fisher Scientifics

Time and Date:

Live: Tuesday, Oct. 13, 2020 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST

On demand available after final airing until Oct. 13, 2021

Sponsor: Thermo Fisher Scientific

Register free: https://www.chromatographyonline.com/lcgc_w/nitrosamine_impurities

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