Accuracy of the method to recover t

Accuracy of the method to recover the active should be established across a specified range for the analytical procedure, so keeping the level of excipients constant for each formulation being tested (a placebo formulation is ideal to use if available), API from 70% to 130% of the nominal concentration should be spiked into the solutions (for products requiring content uniformity, testing the API should be typically spiked in at the range 80–120%). Make a minimum of one preparation at each level.It is possible to determine the accuracy of each related compound separately, but it is more efficient to validate these related compounds in a combined spiked mixture of all the related compounds at their appropriate levels. Impurities can be spiked into the active at levels from the reporting limit to typically 120% of the specification. The analyst should be certain that the impurity standards used to spike the solutions are pure and do not contain significant impurities that would affect the results, by running an unspiked sample of the active, as a control.