Whitepapers/App Notes/Posters

Application note: Nitrosamines in drug product by HRAM-LCMS

Posted: 16 June 2020 | | No comments yet

HPLC with HRAM MS method for the determination and quantitation of nitrosamine impurities in drug products consistent with FDA requirements.

This application note details a simple, fast method using HRAM LCMS consistent with current FDA recommendations, for the quantitative analysis of common nitrosamines in drug product formulations and drug substances.

Application benefits:

  • 11 nitrosamines
  • Confidence in HRAM confirmation of impurities
  • Quantitation of nitrosamines in drug substance and product samples in line regulatory guidelines
  • Acquisition to reporting in GMP compliance-ready software with data integrity and 21CFR11 toolset