Mini-symposium: Method development strategies and devising solutions for nitrosamine analysis


Thursday, 29th April, 2021  
14:30 to 16:30 CET (Berlin, Paris, Madrid)


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

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