Detection and Quantification Challenges of Trace Level Impurities in Pharmaceutical Products - Mutagenic Nitrosamines and Beyond

Separation Science, in collaboration with
VUV Analytics, offers an on-demand discussion forum covering the risk assessment and analytical challenges of detection and quantification of trace level impurities in pharmaceutical products.

Duration: Approximately 75 minutes

Presenters & Panellists:

AdrianClarke_200Adrian Clarke
Global Technical R&D Analytical Network Leader, Novartis

JorgSchlingemann_200Jörg Schlingemann
Principal Expert Quality Control Systems at EMD Serono

TonyBristow_200Tony Bristow
Principal Scientist for Measurement Science, AstraZeneca

NaifferRomero_200Naiffer Romero
Sr Manager, Scientific Affairs, LATAM,
US Pharmacopeia

AmandaGuiraldelli_200Amanda Guiraldelli Mahr
Scientific Affairs Manager,
US Pharmacopeia



RichardLaddRichard Ladd
Independent Pharmaceutical Consultant, UK





Event Overview

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, other mutagenic impurities and will also consider what’s next. With expert leaders in impurity profiling strategies and trace analysis we discuss the risk assessment of mutagenic impurities and the difficulties in analysis from sample preparation through to detection. The importance of sample preparation and matrix effects and how automation may help are discussed as well as how best to avoid false positives. The different technologies available for trace level analysis are considered as well as the difficulties in technology transfer.

By watching this presentation and discussion you will learn:

  • What are impurities and where do they come from
  • Risk analysis, nitrosamine sources and specification setting
  • 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
  • New detector technology including vacuum UV and nitrogen Phosphorus detectors
  • Minimising the risk in technology transfer
  • Unmet analytical needs


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