AOAC Method Validation (August 29, 2018)

Clarification on Number of Calibration Points

Background X A number of well-respected chemists opined that a method, any method, using a single calibration point is riskier in terms of accuracy than a method, any method, that requires multiple calibration points. X The method author pointed out that the data supporting the method, which was acknowledged by the reviewers to be more than adequate to demonstrate the reliability and accuracy of the method, was collected using the single point calibration method.

Clarification on Number of Calibration Points

Background X AOAC has no requirement on the minimum number of calibration points. X SMPR’s are silent on the question on the minimum number of calibration points. X It is acknowledged that addition of a second calibration point will increase the work load of a method and could decrease the through-put.