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.
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: