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Pharmaceutical Chemistry Journal

, Volume 53, Issue 8, pp 766–770 | Cite as

Comparison of Approaches to Determining N-Nitrosodimethylamine Impurity in Valsartan Drug Substance By GC-MS Methods

  • M. D. Khorol’skiiEmail author
  • O. V. Anan’ina
  • A. A. Chaplenko
  • I. V. Nedkov
  • N. V. Maslennikova
  • G. V. Ramenskaya
Article
  • 4 Downloads

Methods for determining the genotoxic impurity N-nitrosodimethylamine (NDMA) in valsartan drug substance by gas chromatography (GC) with mass-spectrometric detection in SIM and MRM modes using direct introduction and vapor-phase analysis are compared. The obtained LOQ and DL differed insignificantly. The test results led to the conclusion that use of a method corresponding to the capabilities and equipment of the laboratory was advisable.

Keywords

quality control GC-MS valsartan NDMA 

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Copyright information

© Springer Science+Business Media, LLC, part of Springer Nature 2019

Authors and Affiliations

  • M. D. Khorol’skii
    • 1
    • 2
    Email author
  • O. V. Anan’ina
    • 2
  • A. A. Chaplenko
    • 2
  • I. V. Nedkov
    • 2
  • N. V. Maslennikova
    • 2
  • G. V. Ramenskaya
    • 1
  1. 1.I. M. Sechenov First Moscow State Medical University (Sechenov University)MoscowRussia
  2. 2.Scientific Center for Expert Evaluation of Medicinal Products, Ministry of Health of the Russian FederationMoscowRussia

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