Reference Standards: The Foundation of Analytical Confidence

The panel addresses one of the most practically frustrating aspects of nitrosamine testing: the quality, availability, and reliability of reference standards. The discussion covers the prevalence of poorly characterized or even chemically impossible standards in the marketplace, what organizations should require as evidence that a standard is genuinely fit for purpose, and the analytical techniques best suited to confirming identity and establishing purity. The panelists also examine the role of stable isotope-labelled internal standards, discussing where they add the most value and sharing examples of situations where their absence has led to significant analytical problems. The segment underscores how the pressure to move quickly in this field has repeatedly led to shortcuts in standard qualification that carry long-term consequences.

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.