The AAPS Journal

, Volume 9, Issue 3, pp E353-E360

First online:

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

  • Nicola C. HughesAffiliated withBiovail Contract Research Email author 
  • , Ernest Y. K. WongAffiliated withBiovail Contract Research
  • , Juan FanAffiliated withBiovail Contract Research
  • , Navgeet BajajAffiliated withBiovail Contract Research


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.


Carryover contamination extraction chromatography detection bioanalysis accuracy precision memory effect