Pharmaceutical Masterclass: Rapid Screening for Elemental Impurities During Drug Substance Development

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During the development of the synthesis process for pharmaceutical APIs, it is critical to ensure that elemental impurities associated with metal catalysts are scavenged prior to downstream processing of the drug substance. Traditionally, the effectiveness of scavenging processes has been determined using plasma-based instrumental techniques, such as ICP-OES or ICP-MS. Although these methods provide a means of accurately detecting very low concentrations of elemental impurities, they can be time-consuming and costly to apply, delaying process development decisions.

With the costs and risks associated with drug development steadily increasing, pharmaceutical companies must focus on how to improve efficiency in the research and development phases. This webinar will explore how and why pharmaceutical process chemists should leverage X-Ray Fluorescence (XRF) as a rapid, easy-to-use, easy-to-deploy elemental impurity screening tool in support of drug synthesis process development. We will present case studies which show how XRF can be applied as a cost-effective and time-effective means of performing metal catalyst scavenger studies, supporting optimization of the effectiveness and efficiency of drug synthesis processes.


About our masterclass host:
Our webinar is the second in a series presented by Nancy Lewen. With 30-years’ experience of working with the pharmaceutical industry and 15-years working with groups considering method standardization for elemental impurity detection, Nancy is a recognized expert in elemental analysis. She is a dedicated scientist with extensive experience in atomic spectroscopy techniques and specializes in providing services associated with metals/metalloid analysis in pharmaceutical applications.

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Who should attend?
- Those interested in enabling more rapid decisions regarding metal catalyst scavenger screening approaches during drug product (API) development and scale up.
- Those interested in the analysis of elemental impurities in pharmaceutical products and ingredients.
- Those interested in drug safety and toxicology with regard to elemental impurities.
- Anyone with an interest in method development for XRF
- Those considering XRF as an alternative to ICP or ICP-MS for the detection and quantitation of elemental impurities during drug substance (API) development.

What will you learn?
- Learn about analytical methods used to detect and measure elemental impurities
- Learn how X-ray fluorescence (XRF) can be applied during drug product development to optimise the effectiveness and efficiency of metal catalyst scavenging processes
- Learn how X-ray fluorescence (XRF) enables the rapid and relative determination of elemental content during API development
- Learn how X-ray fluorescence (XRF) compares to ICP and ICP-MS and where it adds greatest value in pharmaceutical drug product development