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Application note: Nitrosamines by GC-MS in Valsartan

Posted: 18 June 2020 | | No comments yet

Determination of nitrosamines including gentoxic NDMA analysed by GC-MS in Valsartan using direct injection and headspace methods, below required LOD.

A comparison of direct injection and headspace GC-MS and GC-MS/MS methods to determine nitrosamines including genotoxic NDMA and NDEA in Valsartan drug products.

Application benefits are:

  • Demonstrated to comply to FDA & EMA requirements
  • LOD below allowable limits of 0.3ppm
  • GC-MS and GC-MS/MS applied to meet changing regulations
  • Acquisition to reporting in GMP compliance-ready software with data integrity and 21CFR11 toolset