Highly Sensitive and Robust LC-MS/MS Solutions for Quantitation of Nitrosamine Impurities in Metformin Drug Products
With the recent changes in the US FDA published regulatory guidance on controlling the level of nitrosamine impurities in human drugs, there is an eminent need to develop a highly sensitive and robust LCMS solution for routine screening and batch testing of drug substances and products.
Herein, we described a fit-for-purpose LC-SRM-MS method developed using the Vanquish Horizon UHPLC system coupled to a TSQ Quantis triple quadrupole mass spectrometer for the detection and quantitation of 10 nitrosamines in metformin drug products. Not only can this method quantify target nitrosamines as low as 5 ppb using APCI and 10 ppb using HESI, it also provides excellent reproducibility for nitrosamine quantitation over 1,000 sample injections with minimal change in column performance as well as MS sensitivity.
Key learning objectives:
- Discussion around the challenges of nitrosamine impurity analysis
- Sensitive and robust methodology for high throughput projects
- Appropriate technology choices for nitrosamine analysis
Who should attend:
- Analysts, team leaders, data integrity specialist, QA auditors & lab managers in Pharma analytical testing environments
- Scientists and chemists at the analytical science testing laboratories, CDMOs or pharmaceutical manufacturers
- Analysts and companies performing nitrosamine analysis in drug products and drug substances
Presenter: Dr. Hao Yang (Sr. Product Application Scientist, Thermo Fisher Scientific)
Dr. Hao (Mark) Yang is a Sr. product application scientist in the pharma and biopharma vertical marketing group at Thermo Fisher Scientific. Mark graduated from University of British Columbia with BSc honors in both Chemistry and Biochemistry, then completed his Ph.D. in Analytical Chemistry from University of Toronto, working with Professor Aaron Wheeler on developing novel microfluidics-to-mass spectrometric interfaces for bioanalytical applications. Prior to joining Thermo Fisher Scientific, Mark had spent over 7 years at SCIEX as a research scientist developing next generation nano and micro flow LC systems, and designing various microfluidics chips for sample preparation and LC applications.
