The presence of nitrites in excipients has evolved as a hot topic among regulatory agencies across the world. Nitrites in excipients are seen as a risk factor to form nitrosamines in the presence of vulnerable amines during the drug product manufacturing process and storage. Health Authorities worldwide imposed recalls on drug products. Our data indicate that the presence of nitrosamines in pharmaceuticals is likely more prevalent than originally expected. This webinar will review the current regulatory considerations, the role of nitrites, and the analytical controls. We will also look at a case study on risk mitigation.
Ulrich Reichert, Ph.D.
Global Regulatory Management
Ulrich Reichert heads the regulatory management - pharma and food materials organization of the life science business of Merck KGaA, Darmstadt, Germany. He is responsible for registration of APIs and excipients with health authorities (master files), and he acts as the principal contact for site registration with the GMP-supervisory authority. Ulrich is a pharmacist by training, holds a Ph.D. and an M.S. in drug regulatory affairs, and has more than 20 years of experience in quality and regulatory requirements for raw and starting materials in the pharmaceutical industry.
Joerg Schlingemann, Ph.D.
Director, Global Quality Control Principal Expert
Joerg Schlingemann is a director and principal expert for quality control systems within MilliporeSigma'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, Ph.D.
Senior Manager for Analytical and Preparative Liquid Chromatography
Sebastian Hickert is a senior manager for analytical and preparative liquid chromatography within MilliporeSigma's central analytical department. He obtained his Ph.D. in food chemistry from the University of Münster. Sebastian joined MilliporeSigma 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.
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