Webinar | Intertek – Nitrosamine Testing – Wednesday 13th May ~ 5pm CEST

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Date/Time
Date(s) - 13/05/2020
5:00 pm - 6:00 pm

Categories


Nitrosamine (genotoxic) impurities have been found in some angiotensin II receptor blocker (ARB) medicines, such as valsartan, and more recently in histamine-2 receptor blocker medicines, such as ranitidine, drawing close scrutiny from FDA, the European Medicines Agency (EMA) and other regulatory bodies.

 

Gas chromatography–mass spectrometry (GC-MS) has typically been the detection technique of choice; however, not all nitrosamines can be analyzed this way. As the number of known nitrosamines requiring trace level quantitation increases, the greater the need for robust, sensitive, and high-throughput assays to provide a cost-sensitive approach of a single analysis capable of accurately measuring all compounds. The use of liquid chromatography with high-resolution MS (LC-HRMS) allows low level detection and high confidence of a wider range of nitrosamine impurities.

 

Here we will describe analytical options to solve nitrosamine analysis challenges.

Key Learning Objectives:

  • Why is the analysis of genotoxic impurities important?
  • How can cost-sensitive genotoxin impurity analysis be delivered using high-resolution mass spectrometry?
  • Can high-resolution mass spectrometry be easily implemented under GMP conditions?

Who Should Attend:

  • Laboratory directors
  • Technology leaders
  • Study directors
  • Principal scientists

For questions please contact Martha Devia: mdevia@mjhlifesciences.com

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