Three - Stage Statistical Dissolution Testing Procedures

I. Introduction The US Food and Drug Administration sets performance limit on dissolution in terms of a specific percentage Q that the drug product is required to be dissolved at a specified time. Based on inferences from correlated bioavailability studies, these dissolution specifications were intended to assure that at least 80% of the labeled quantity of drug was available. When carried out appropriately, dissolution analysis of pharmaceutical drugs has been identified as an important test to assure the quality of a drug product 1. To ensure that the manufacturing procedure yields a product equivalent to what formed the basis of NDA (New Drug Application) approval, dissolution testing is required by US FDA to confirm that the dissolution is consistent with the declared dosage