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Glimpses of the 1st edition of Nitrosamine Impurities Forum 2020

Industry Landscape



Nitrosamines, or more correctly N-nitrosamines, refer to any molecule containing the nitroso functional group.These molecules are of concern because nitrosamine impurities are probable human carcinogens. Although they arealso present in some foods and drinking water supplies, their presence in medicines is nonetheless considered unacceptable.
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Speakers



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Focus of the Forum


Understanding the global regulatory and toxicological limits to combat nitrosamine impurities
Strategies to identify these impurities at the right stage
Risk-based approach and key analytical techniques to identify these impurities
Analytical and Chemical assessment to address nitrosamine impurities
Sources of nitrosamine impurities and adopting correct methods available to avoid product recall
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Who will attend

Industries

Pharmaceuticals

Life Sciences

Bio-Pharmaceuticals

API Manufacturers

Departments
Quality Assurance / Quality Control
R&D
Production & Manufacturing
Analytical
Regulatory
Packaging

Who should Partner?



Analytical equipment providers

  • GC-MS -MS
  • LC-MS-MS
  • Orbitrap
  • HPLC-MS
  • Nitrogen Chemiluminescence Detector
  • Small benchtop instruments

Industry experts assisting pharmaceutical industry through all the steps of investigation from risk assessment to analytical methods in order to confirm the levels of nitrosamine impurities in drug substances and drug products.

  • Chromatographic Columns
  • Filters
  • Chemical and AR-Grade Standards