Detection and Quantification Challenges of Trace Level Impurities in Pharmaceutical Products - Mutagenic Nitrosamines and Beyond
This virtual forum will discuss 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 will 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 will be discussed as well as how best to avoid false positives. The different technologies available for trace level analysis will be considered as well as the difficulties in technology transfer.
By attending this webinar 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
Presenter: Adrian Clarke (Global Technical R&D Analytical Network Leader, Novartis)
Presenter: Jörg Schlingemann (Principal Expert Quality Control Systems at EMD Serono)
Presenter: Tony Bristow (Principal Scientist for Measurement Science, AstraZeneca)
Presenter: Naiffer Romero (Sr Manager, Scientific Affairs, LATAM, US Pharmacopeia)
Presenter: Amanda Guiraldelli Mahr (Scientific Affairs Manager, US Pharmacopeia)
