Accuracy

Accuracy is the measure of exactness of the analytical method.

Accuracy is determined as follows:

•At the assay level, a blank drug substance preparation or drug product placebo is spiked with the active ingredient at 3 levels (70-130%) and recovery is determined.

•At the related compound level, a blank drug substance preparation or drug product placebo is spiked with known related compounds at 3 levels (0.05–2%) and recovery is determined.