The AAPS Journal

, Volume 9, Issue 3, pp E353–E360

Determination of carryover and contamination for mass spectrometry-based chromatographic assays

  • Nicola C. Hughes
  • Ernest Y. K. Wong
  • Juan Fan
  • Navgeet Bajaj
Article

DOI: 10.1208/aapsj0903042

Cite this article as:
Hughes, N.C., Wong, E.Y.K., Fan, J. et al. AAPS J (2007) 9: E353. doi:10.1208/aapsj0903042

Abstract

The Third American Association of Pharmaceutical Scientists/Food and Drug Administration Bioanalytical Workshop, held in 2006, reviewed and evaluated current practices and proposed that carryover and contamination be assessed not only during the validation of an assay but also during the application of the method in a study. In this article, the potential risks of carryover and contamination in each stage of a bioanalytical method are discussed, to explain to the industry why this recommendation is being made.

Keywords

Carryovercontaminationextractionchromatographydetectionbioanalysisaccuracyprecisionmemory effect

Copyright information

© American Association of Pharmaceutical Scientists 2007

Authors and Affiliations

  • Nicola C. Hughes
    • 1
  • Ernest Y. K. Wong
    • 1
  • Juan Fan
    • 1
  • Navgeet Bajaj
    • 1
  1. 1.Biovail Contract ResearchToronto