Analysis of Five Nitrosamine Impurities in Drug Products and Drug Substances Using Agilent GC-MS/MS Instrumentation
To date, sartan drugs belonging to more than 1,100 different lots have been recalled because they contained above regulatory limit levels of nitrosamines – a group of organic compounds of which many are either known or are suspected to be carcinogenic. To prevent the recurrence of such events, it is paramount that drug manufacturers have powerful tools for analyzing nitrosamine impurities.
In this app note, discover a comprehensive solution for trace-level determination and estimation of nitrosamine impurities in sartan drug products, that is designed to ensure:
- High sensitivity
- Reliability
- Repeatability
