Virtual seminar session 2: Solutions for nitrosamine analysis by GC-MS
Nitrosamine (genotoxic) impurities have been found in some angiotensin II receptor blocker (ARB) medicines, such as valsartan, and more recently in histamine-2 receptor blocker medicines, such as ranitidine, drawing close scrutiny from FDA, the European Medicines Agency (EMA) and other regulatory bodies leading to product recalls.
Gas chromatography–mass spectrometry (GC-MS) has typically been the detection technique of choice; however, not all nitrosamines can be analyzed this way. As the number of known nitrosamines requiring trace level quantitation increases, the greater the need for robust, sensitive, and high-throughput assays to provide a cost-sensitive approach of a single analysis capable of accurately measuring all compounds. The use of liquid chromatography with high-resolution MS (LC-HRMS) allows low level detection and high confidence of a wider range of nitrosamine impurities.
Session breakdown:
11:00 CEST, 20 minutes + Q & A
Analytical Challenges and Solutions for determination of Nitrosamine impurities by GC-MS
Presenter: Dr. (Mrs.) A. Sivalakshmi Devi, Senior G.M., Analytical R&D API, Generics Laurus labs, Hyderabad, India
11:30 CEST, 20 minutes + Q & A
Determination of NDMA in Metformin drug products using GC-Orbitrap MS
Presenter: Dr Xiaowei Ge, Health Authority, Singapore
12:00 CEST, 20 minutes + Q & A
Advanced GC-MS technologies serving pharmaceutical laboratories for nitrosamines testing
Presenter: Giulia Riccardino, Senior Applications Specialist, GC, GC-MS, Thermo Fisher Scientific
This session will deliver an overview of GC-MS technology and the applications for nitrosamine testing. Hear from the Health Authority in Singapore on how they tackle this challenging analysis using GC-Orbitrap instrumentation. You will have the opportunity to ask questions to our specialists and guest speaker
Key Learning Objectives:
- What GC-MS technology solutions are available for nitrosamine analysis
- GC-MS applications to analyse nitrosamines robustly
- How nitrosamine analysis is currently handled in customer laboratory
Presenter: Dr Xiaowei Ge (Consultant Analytical Scientist, Pharmaceutical Lab, Singapore Health Sciences Authority)
Dr Xiaowei Ge obtained his PhD degree in Natural Product Chemistry at the National University of Singapore. He joined Singapore Health Sciences Authority as an analytical scientist in Pharmaceutical Laboratory in 2007. Currently Dr Ge is working as Consultant Analytical Scientist leading R&D team in Pharmaceutical Laboratory. Throughout the years’ work at Pharmaceutical Laboratory, Dr Ge’s team have established their expertise and international reputation in using different analytical techniques such as NMR and MS to detect and identify adulterants found in dietary supplements. His team have a great contribution to the determination of PDE‐5 inhibitor analogues structures. Dr Ge’s team also works on development of LC‐MSMS and GC‐MSMS methods for trace analysis in different sample matrix, e.g., natural substances and contaminants in herbal medicines, nitrosamines in different drug products, etc. His team together with collaborators worldwide have published more than 30 scientific papers in different journals in these areas.
Presenter: Giulia Riccardino (Sr Product Applications Specialist, Thermo Fisher Scientific)
Giulia Riccardino is a senior applications specialist for the GC-GC/MS business unit. Before joining Thermo Fisher Scientific she worked for more than 10 years as a biologist in a clinical and toxicology lab where she had an extensive experience with both gas and liquid chromatography. She started at Thermo Fisher as a product specialist for GC standalone andautosamplersand then she relocated to Runcorn (UK) to join the applications specialist team.Giulia holds a degree in Biology from the University of Milan with a further Specialization in Clinical Biochemistry.
