The Analytical Challenge: Detection, Quantification, and Method Development

The panel digs into the practical difficulties of detecting and quantifying nitrosamines at trace levels across complex matrices. The conversation covers the instrumentation demands of working at the required sensitivity, the challenges this creates for quality control laboratories, and the difficult business decisions organizations face around in-house capability versus outsourcing. The panelists discuss what makes method development for nitrosamines particularly demanding, from instrument selection and detector optimization through to pre-analytical sample treatment and the management of matrix effects. The segment also explores the specific challenges of method validation, transfer between sites and instruments, and what it takes to ensure a method remains fit for purpose in routine use over the long term.

Moderated by Joseph Lackey, Technical Manager at LGC Standards, the discussion brings together Jason Brown, Principal Consultant at Brown Pharma Consulting Ltd, Maria Kristina Parr, a professor in pharmaceutical chemistry from the Freie Universität Berlin, Jörg Schlingemann, Director, Principal Expert Quality Control Systems at Merck Healthcare KGaA, and George Johnson, an associate professor at Swansea University.