Mini-symposium: Method development strategies and devising solutions for nitrosamine analysis
In a first for our chromatography series we bring you a mini symposium of webinars looking at the important area of method development in HPLC followed by a look into methods for the key area of nitrosamines analysis in pharmaceuticals:
Webinar 1: A Systematic UHPLC/HPLC Method Development Strategy with Complementary Stationary Phases to Maximise Selectivity and Resolution
In this seminar, we review the importance of chromatographic selectivity in RPLC from a theoretical and practical perspective and how this relates to analyte resolution for method development. With an understanding of selectivity, and using a variety of chromatographic data, we discuss phase design principles and how it is possible to introduce functionality to enhance selectivity through mechanisms such as hydrophobicity, π-π, dipole-dipole and shape selectivity interactions.
An overview of the method development workflow is discussed. Based upon the key parameters to maximise selectivity, a systematic and optimised method development screening platform is described and an example related substances method development activity is illustrated using the complementary stationary phases with MeOH and MeCN solvents. Q&A with the experts at Avantor Chromatography (15 minutes)
Webinar 2: Analysis of nitrosamines in APIs
Since 2018, NDMA and other nitrosamines have been observed in a range of different pharmaceuticals. This webinar will look at the chronological development of the story and how nitrosamines have caused the pharmaceutical industry to re-evaluate their manufacturing procedures.
It will look at the synthetic pathways that can cause the generation of this range of genotoxins and the regulatory landscape that has evolved as a consequence of the initial findings. We will then discuss the development of a series of applications that will allow for the determination of a range of nitrosamines that have been identified by the FDA as genotoxins to monitor.
Presenter: Gemma Lo
Gemma Lo is a key part of the business development team at Avantor, and is responsible for leading a wide range of HPLC and UHPLC training events and seminars across Europe. Gemma has over a decade of experience working in the technical support team, troubleshooting chromatography methods, recommending suitable column chemistries, and supporting the vast range of HPLC and UHPLC columns in the portfolio. Originally a Biochemist, her focus areas include the analysis of biomolecules by various chromatographic techniques, and the analysis of polar analytes.
Presenter: Tony Edge
Tony Edge is the R&D Manager at Avantor, heading a team of specialist scientists in developing next generation stationary phases for HPLC. He has worked in both manufacturing and also industry, having periods of employment at LGC and also AstraZeneca as well as ThermoFisherScientific and latterly Agilent Technologies. In 2008, he was fortunate enough to be awarded the Desty memorial lecture for his contributions to innovating separation science, and in the same year also won a clinical excellence award from AstraZeneca. Tony’s current interests are centered on improving the extraction process and high-temperature chromatography. Tony was awarded an honorary fellowship at the Liverpool university, where he lectures on separation science, and also lectures at Keele University on Management in Analytical Science. Tony is also the President of The Chromatographic Society in the UK and a contributing editor for the Chromatography Today magazine. Tony is also part of the Reid Bioanalytical conference organising committee, and a permanent member of the scientific committee for the International Symposium on Chromatography.
