This webinar brings together the authors of two recently published papers to walk through their findings, discuss methodology, and explore what their work means for nitrosamine risk assessment in practice. Hosted by Lhasa Senior Scientist Gem Packer, the session will cover how in silico tools and industry data sharing are being applied to identify and inform nitrosamine risk mitigation strategies, drawing directly on research conducted through the Lhasa Nitrites consortium, a global industry collaboration pooling excipient nitrite data to reduce testing burden and build shared analytical knowledge.
Giorgio Blom (AstraZeneca) will present findings from a six-laboratory comparative testing study examining how nitrite levels in common pharmaceutical excipients can be measured, and where results diverge depending on the method, extraction procedure, and matrix involved. He’ll walk through what the consortium learned from testing microcrystalline cellulose, magnesium stearate, and lactose across labs using IC-CD, Griess/LC-UV, and DAN/LC-FLR, and discuss what this means for method validation guidance going forward.
Sébastian Hickert (Merck) will present his published overview of analytical techniques for nitrite quantification in excipients, covering IC, Griess derivatisation, DAN derivatisation, and cyclamate derivatisation, and discuss how the Lhasa Nitrites database has informed understanding of achievable detection limits and the practical trade-offs between techniques. He’ll offer guidance on how to select an appropriate method for your context. Gem Packer will open the session with an introduction to the applicability of in silico tools and the role of data sharing in building a robust, risk-informed approach to nitrosamine control.
Who should attend
This session is aimed at analytical chemists and regulatory scientists working in pharmaceutical development and manufacturing. Whether you’re involved in nitrosamine risk assessment, excipient evaluation, or impurity control strategy, this is a rare opportunity to hear directly from the authors behind recently published work in this area, and to put your questions to them.
Can I get involved in the consortium?
the Lhasa Nitrites Data Sharing Initiative, an industry consortium pooling nitrite data from pharmaceutical excipients, solvents, and reagents contributed by member companies worldwide. If your organisation is involved in nitrosamine risk assessment and you’d like to benefit from, and contribute to, this growing evidence base, we’d love to hear from you. Find out more about joining the consortium →