Analysis of nitrosamine impurities: an interview with Javier Jimenez-Villarin
About the speaker
Javier Jimenez-Villarin
Support & Applications Specialist
Waters Corporation
Javier Jimenez-Villarin received his PhD in analytical chemistry from the University of Barcelona (Barcelona, Spain). For his thesis, Javier utilized state-of-the-art LC–HRMS/MS and ion mobility mass spectrometry to identify and characterize pharmaceutical transformation products and their metabolites. Javier then joined a CDMO where he applied his knowledge of analytical instrumentation to the resolution of complex contract manufacturing analysis projects and the characterization of API impurities utilizing HRMS/MS. He joined Waters Corporation in 2019 as a Support & Applications Specialist, focusing on delivering innovative and fit-for-purpose solutions to customers in a wide variety of scientific fields, such as pharma, biopharma, clinical, food and environment and chemical materials. This has included the development of novel analytical methods for the detection and quantification of nitrosamine impurities in raw materials, active pharmaceutical ingredients and final product formulations utilizing LC–MS/MS.
Questions
- Nitrosamines are genotoxic impurities that have made their presence known in the pharma industry. To what levels do you believe nitrosamines need to be determined? [00:31]
- What considerations do you take into account when creating a new method for nitrosamine analysis? [02:14]
- What are the main technical challenges you usually face when setting up a new method for nitrosamine analysis? How do you overcome them? [03:37]
- What are the different technologies that might be needed and when would each of them be necessary for an individual lab? [06:28]
- How has the transition and/or technology transfer been from HPLC–UV/Vis to UPLC–MS/MS in QC labs? [08:45]
- As a final thought, do you see nitrosamines going away at any point and do you see any new impurities in the near future? [10:30]
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