Determining Trace Levels of Nitrosamine Impurities Using GC/MS/MS



To date, several sartan drugs have had to be recalled due to the presence of unacceptable levels of nitrosamines – a group of organic compounds of which many are either known or suspected to be carcinogenic. To prevent the recurrence of such events, it is paramount that drug manufacturers have powerful tools at their disposal for analyzing nitrosamine impurities, to ensure levels remain below regulatory limits.

In this app note, discover a comprehensive solution that can:

  • Deliver confident trace analysis of NDMA, NDEA, NEIPA, NDIPA and NDBA impurities
  • Allow for LOQs that are 2 to 20 times lower than what is required by current regulations
  • Achieve high sensitivity, reliability and repeatability