Comparison of the recovery spread in analytical development and routine quality control--based on the ICH quality guideline Q2B.

In the present study, a simulation was performed for the ICH Q2B guideline for assessing the accuracy. By means of an experimental data set a permutation has been performed to investigate in which interval experimental mean recovery can be expected to scatter just by random effects. A good agreement has been found between the experimental intervals obtained by means of a permutation and the statistically derived confidence intervals. These findings could be confirmed with additionally generated virtual data sets with a true mean of 100% and a true standard deviation of 0.7%.