| • | The generic quantification of six volatile N-nitrosamines (NDMA, NDEA, EIPNA, DPNA, DIPNA, NDBA between 20-100 ppb) within chemically manufactured APIs and DPs with an LOD of 10 ppb. |
| • | And the use of HRAM-LC/MS equipment for trace analysis with Q-Standard GMP, volatiles and non-volatile N-nitrosamines |
| • | 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 |
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.
