Managing Nitrite Impurities: Supplier-Manufacturer View

Ulrich leads a global team supporting regulatory compliance for manufacturing active and biologic drug substances, including site registrations worldwide. With over 25 years of experience in regulatory and quality roles, he holds a PhD in Medicinal Chemistry and a Master in Drug Regulatory Affairs. Ulrich chairs the IPEC Europe Nitrosamine Task Force, participates in ICH and European Pharmacopoeia expert groups, and serves on the pharmacopoeia committee on medicinal chemistry at BfArM.

Joerg Schlingemann is a director and principal expert for quality control systems within Merck's healthcare quality unit. He studied molecular biology in Uppsala and Heidelberg, where he completed a doctorate degree at the German Cancer Research Center in 2005. He has 14 years of experience in the pharmaceutical industry in various roles within quality control and quality assurance. Since late 2019, Joerg has been leading EMD Serono’s analytical activities for N-nitrosamines, based on which he has authored or co-authored several scientific publications dealing with analytical challenges, NDMA in metformin, nitrite in excipients, and the prevalence of NDSRIs. Joerg is an advocate of scientific collaboration, data sharing, and expressive visualization of data.

Sebastian Hickert is a senior manager for analytical and preparative liquid chromatography within Merck's central analytical department. He obtained his Ph.D. in food chemistry from the University of Münster. Sebastian joined Merck in 2017 as a senior scientist before moving to managerial roles. His team uses liquid chromatography techniques such as (U)HPLC, IC, SFC, TLC, and others hyphenated to various detection options. Over the past few years, Sebastian's team has analyzed several hundred chemicals for nitrite and contributed to several scientific publications.