Trace Level Impurities in Pharmaceuticals

by | Jun 27, 2022

Learn more about the risk assessment and analytical challenges of detection and quantification of trace level impurities in pharmaceuticals.

This virtual forum discusses the risk assessment and analytical challenges of detection and quantification of trace level impurities in pharmaceutical products including mutagenic nitrosamine impurities.


Format: On-demand

Duration: Approx. 75 minutes

In this forum, thought leaders in impurity profiling strategies and trace analysis discuss the risk assessment of mutagenic impurities and the difficulties in analysis from sample preparation through to detection. In addition, the key issue of how automation can help is discussed. The different technologies available for trace level analysis are considered as well as the difficulties in technology transfer. Impurities other than nitrosamines are also considered, as well as what might be around the corner.

By viewing this presentation you will learn:

  • What are impurities and where do they come from
  • Regulatory and compendial perspectives
  • Alleviating the risk of impurity formation by better understanding of the active pharmaceutical ingredients, its source and manufacturing process
  • Difficulties in sample preparation, what to do and not to do
  • The use of automation in trace level impurity analysis
  • How to avoid false positives and consideration of matrix effects
  • The different types of technologies available for trace impurity analysis
  • Minimising the risk in technology transfer
  • Unmet analytical needs.

The Presenters & Presenters & Panellists:

AdrianClarke_200Adrian Clarke
Global Technical R&D Analytical Network Leader, Novartis
JorgSchlingemann_200Jörg Schlingemann
Principal Expert Quality Control Systems, EMD Serono
AmandaGuiraldelli_200Amanda Guiraldelli
Scientific Affairs Manager,
US Pharmacopeia
TonyBristow_200Tony Bristow
Principal Scientist for Measurement Science, AstraZeneca
NaifferRomero_200Naiffer Romero
Sr Manager, LATAM,

US Pharmacopeia
RichardLaddRichard Ladd
Independent Pharmaceutical Consultant - MODERATOR



Related Content