Detection of low-level PTFE contamination: An application of solid-state NMR to structure elucidation in the pharmaceutical industry

J Pharm Biomed Anal. 2011 Jan 25;54(2):401-5. doi: 10.1016/j.jpba.2010.08.027. Epub 2010 Sep 28.

Abstract

We report a novel use of solid-state ¹⁹F nuclear magnetic resonance to detect and quantify polytetrafluoroethylene contamination from laboratory equipment, which due to low quantity (up to 1% w/w) and insolubility remained undetected by standard analytical techniques. Solid-state ¹⁹F NMR is shown to be highly sensitive to such fluoropolymers (detection limit 0.02% w/w), and is demonstrated as a useful analytical tool for structure elucidation of unknown solid materials.

MeSH terms

  • Dosage Forms
  • Drug Contamination / prevention & control*
  • Limit of Detection
  • Magnetic Resonance Spectroscopy / methods*
  • Pharmaceutical Preparations / analysis*
  • Pharmaceutical Preparations / chemistry*
  • Polytetrafluoroethylene / analysis
  • Polytetrafluoroethylene / chemistry

Substances

  • Dosage Forms
  • Pharmaceutical Preparations
  • Polytetrafluoroethylene