Analysis of Nitrosamines in Drugs Using Chromatographic Methods According to Regulatory Requirements

In foods, nitrosamines have been an issue for many years. This concern has recently extended to pharmaceuticals. Most notably, unwanted nitrosamine side products were detected in the sartan class blood pressure medications (angiotensin-II-receptor antagonists) of many pharmaceutical companies, leading to a long string of product recalls and thus sales losses and potentially reputational damage. Nitrosamines in at least four categories of drugs are currently receiving scrutiny. Many professionals expect that nitrosamine impurities testing could extend to a lot more than APIs and finished drug products in the future.

That’s why we’re hosting a live round-table discussion about the various chromatographic methods to quantify these carcinogenic substances in drugs in accordance with regulations. Industry and lab professionals can now register for the Q&A webinar on October 6th, 2022, in which a panel of experts will discuss the testing methods described in the different regulations, the analytical techniques and consumables to use, and participants will be able to ask questions. The panel discussion will be moderated by Dr. Patrik Appelblad, senior principal scientist for HPLC & instrumental analysis R&D at Merck KGaA, Darmstadt, Germany.

In this webinar, you will learn:

• What nitrosamines are, how they’re formed, why they’re a concern
• The regulatory landscape for nitrosamine testing
• Different analytical approaches to nitrosamine testing

Presenter: Egidijus Machtejevas, Ph.D. (Senior Techical Advisor, Merck, KGaA Darmstadt, Germany)

Egidijus Machtejevas was born in Kaunas, Lithuania where he studied chemistry, biotechnology and separation sciences (1991- 2001) at Kaunas University of Technology, Lithuania. After gaining his PhD in analytical chemistry 2001-2007 he worked as a post-doc at Mainz University, Germany. He joined Merck KGaA in Darmstadt in 2008. Currently he is a Senior Technical Advisor in Analytical Chromatography Workflows group. Egidijus has twenty-five scientific papers and thirteen book chapters to his name.

Presenter: Ulrich Reichert, Ph.D. & M.D.R.A. (Head of CDMO and Bioprocess Materials, Regulatory Management, Merck, KGaA Darmstadt, Germany)

Ulrich Reichert heads the "Regulatory Management - CDMO and Bioprocess” organization of the Life Science business of Merck KGaA, Darmstadt, Germany. He is in a leading position of the nitrosamine task forces of IPEC Europe, member of the APIC nitrosamine task force and leads the same of the Life Science business sector of Merck KGaA, Darmstadt, Germany. He is pharmacist by training, holds a PhD and a Master of Drug Regulatory Affairs.

Presenter: Ilona Matus, MBA (Senior Segment Marketing Manager Pharma & Biotech, Merck, KGaA Darmstadt, Germany)

Ilona Matus is senior marketing manager for the Pharma&Biotech Chemistry Laboratory segment at Merck KGaA, Darmstadt, Germany. She was born in Budapest, Hungary. She studied chemistry at the Eötvös Loránd University in Budapest, where she got also her promotion in organic chemistry. After her MBA she held various positions in sales, marketing and business development.

Presenter: Frank Michel, Ph.D. (Analytical & Chromatography Scientific Advisor, Merck, KGaA Darmstadt, Germany)

In his position as Analytical & Chromatography Scientific Advisor, Dr. Frank Michel supports commercial colleagues with training and technical advice. After his diploma and PhD in Analytical Chemistry, Frank led an HPLC lab at a biopharmaceutical company and was later responsible for marketing at a contract testing lab for Pharma industry. With Sigma-Aldrich and then Merck, KGaA Darmstadt, Germany, he has had various roles in marketing, product development, business development and sales of analytical products.

Presenter: Lukas Rigger, Ph.D. (Senior Scientist R&D, Merck, KGaA Darmstadt, Germany)

Lukas Rigger, Ph.D., is senior scientist in the reference materials R&D at Merck KGaA Darmstadt, Germany. He studied chemistry at the university in Innsbruck (Austria) and holds a PHD in organic chemistry. His main focus is the synthesis of new reference materials for pharma, environmental and diagnostic uses.

Presenter: Patrik Appelblad, Ph.D. (Senior Principal Scientist for HPLC & Instrumental Analysis R&D, Merck, KGaA Darmstadt, Germany)

Patrik Appelblad, Ph.D., is senior principal scientist for HPLC & instrumental analysis R&D at Merck KGaA Darmstadt, Germany. He was born in Umea, Sweden, where he studied chemistry and medicine (1991- 2001). He holds a PhD in Analytical Chemistry and serves as an adjunct associate Professor at Umeå University, Sweden. His background includes R&D, product management, Marketing, Strategy and Business development.