Accurate Determination of Trace Nitrosamines in Sartan, Ranitidine and Metformin Based Drugs


  • Date
    October 20, 2020
  • Time
    8:00 a.m. PDT, 11:00 a.m. EDT, 16:00 BST, 17:00 CEST - Duration: 60 Minutes

Date : October 20, 2020
Time : 8:00 a.m. PDT, 11:00 a.m. EDT, 16:00 BST, 17:00 CEST - Duration: 60 Minutes
  • Overview

    Several sartan, ranitidine and metformin-based drug products were recently recalled due to the presence of unacceptable amounts of mutagenic nitrosamine impurities. The USFDA and other regulatory agencies have provided analytical testing guidance for the evaluation of trace nitrosamine impurities in these drug substances and drug products. Consequently, API and drug product manufacturers are under increased pressure to accurately identify and quantify mutagenic impurities in APIs and drug products.

    In this presentation, we will present the relevant GC/MS and LC/MS based analytical strategies to accurately detect and quantify nitrosamines in sartan, ranitidine, and metformin-based drugs.

    Register now for the previous webinar in the series, live October 15, 2020, available on demand after October 16:
    Analysis of Nitrosamine Impurities in Pharmaceuticals – Current challenges and future perspectives

    Brought to you by:

    Agilent Technologies

  • Speakers

    Soma Dasgupta, Ph.D.
    Application Engineer, GC/GCMS,
    Agilent Technologies
    Chander Mani
    Application Engineer,
    Agilent Technologies
    Kartheek Srinivas Chidella
    Application Engineer,
    Agilent Technologies
    Kelly McSweeney
    Contributing Editor,
    C&EN Media Group