When: On-demand

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 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 watching this presentation 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

To watch, click on the link below: