The most commonly reported results from dissolution testing for establishing the performance of oral products (e.g. tablets/capsules), in particular for immediate-release (IR) products, is that products should meet a criterion of not less than 80% drug dissolution within less than 60 minutes, mostly 30 minutes.
Let us assume that a dissolution test (n=6) provides the following results (% drug dissolved) at 30 minutes (96, 88, 65, 110, 66, 65; Ave = 82; RSD = 23%). Obviously, this test/product, with a Q of 80%, would not meet the USP tolerance at the first stage. However, with a bit of luck and the second round of testing of 6 units it may meet/pass the USP Tolerance criteria. For details, please see the link, in particular the data set in row one.
Let us discuss the interpretation of these observed results. Read the rest of this entry �