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HRAM LC-MS method for the determination of nitrosamine impurities in drugs

Application benefits

  • Detection and quantification of nine nitrosamines with a single liquid chromatography-high resolution accurate mass (HRAM) mass spectrometry method
  • Quantitation of nitrosamine impurities in ranitidine drug substance and product below the daily acceptable intake level, that meets the requirements of FDA regulatory guidelines
  • Use of Thermo Scientific™ Chromeleon™ Chromatography Data System (CDS) software for both data collection and processing in a 21 CFR 11 compliant environment with full data integrity and security capabilities for cGMP facilities

Goal

To demonstrate fast, highly sensitive quantitation of nine nitrosamines with a Thermo Scientific™ Orbitrap Exploris™ 120 mass spectrometer, and the use of the LC-MS method to measure nitrosamine impurities in commercially available ranitidine drug substances and products

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