The AAPS Journal

, Volume 9, Issue 3, pp E353–E360 | Cite as

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

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

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

Carryover contamination extraction chromatography detection bioanalysis accuracy precision memory effect 

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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

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