Search Thermo Fisher Scientific
Comprehensive solutions to Nitrosamine impurity analysis in APIs and DPs: an industry case study in meeting EMA Requirements from June 2020
Dr. Karl Abele describes the Solvias approach to N-Nitrosamine analysis focusing on two approaches.
- Generic quantification of six volatile N-nitrosamines (NDMA, NDEA, EIPNA, DPNA, DIPNA, NDBA between 20-100 ppb) within chemically manufactured API’s and DP’s with an LOD of 10 ppb.
- Use of HRAM-LC/MS equipment for trace analysis with Q-Standard GMP, volatiles and non-volatile N-nitrosamines Dr. Hao Yang, Thermo Fisher Scientific, will describe the development of an analytical method for a range of nitrosamines and how the Thermo Scientific Orbitrap Exploris 120 mass spectrometer provides reliable and comprehensive information on nitrosamines impurities that may be present in pharmaceutical products, all under compliance-ready control with Thermo Scientific Chromeleon Chromatography Data System.
Participants will learn
- A range of strategies for nitrosamine analysis
- Overview of current regulatory landscape for genotoxic impurities
- Utilization of high-resolution accurate mass (HRAM) mass spectrometry systems for increased confidence in data
- A comparison of different approaches to the problem
You will learn
- What technology is required to have the deepest proteome coverage for shotgun proteomics
- What methods are used to improve peptide identification rates in short LC gradients
- What performance of the new instrument is expected for data-dependent acquisition (DDA) and data-independent acquisition (DIA) modes
About the Speakers
Dr Karl Abele, Team Leader Extractables & Leachables at Solvias AG
Dr. Abele has specialized in use and development of hyphenated MS equipment since 1986 at the Ruhr University in Germany, where he obtained a Ph.D. in chemistry in 1990. In 2010 he joined Solvias, a Basel based contract research organization serving pharmaceutical manufacturers worldwide. He is currently leading a group of 15 scientists, performing identification and quantification of impurities in drug products at ultra-trace level, as well as E&L studies. He and his team have been involved in analytical evaluation of nitrosamines from the start in June 2018 and have continuously improved their methodology and software solutions applied.
Dr. Hao Yang, Sr Product Application Scientist, Pharma and BioPharma group, Thermo Fisher Scientific
Dr. Yang graduated from the University of British Columbia with BSc honors in both Chemistry and Biochemistry, then completed his Ph.D. in Analytical Chemistry from University of Toronto.