There are three stages of dissolution acceptance criteria:

S1 stage: The dissolved amount of each unit in S1 stage should not be less than Q+5%. It shows that each product should exceed 5% of the dissolved amount specified in the individual Manograph.

If any of the units falls below the limit, then we have to reanalyse the sample in the next stage. i.e. S2 stage.

S2 Stage: In stage S2, additional 6 units are to be executed, so the average of 12 units (S1+S2) should be equal to or more than Q and no unit should be less than Q-15%. It gives some flexibility to the test results but the average should be equal to or more than Q and one unit below the Q is acceptable. 

If any unit falls below Q-15% or the average for 12 units is lower than Q then the sample is analyzed in the S3 stage.

S3 Stage: In stage S3, another 12 units are to be analyzed, the average of 24 units (S1+S2+S3) should be equal to or more than Q and no unit is less than Q-25% and not more than 2 units are less than Q-15%. In this S3 dissolution stage, 3 units are acceptable below Q, which gives more flexibility.

Dissolution test is done to verify the releasse of drug in the solution from the tablet because of blinders granulation and mixing and the coating may effect the releasse of drug from tablet.

Dissolution test is done to verify the releasse of drug in the solution from the tablet because of blinders granulation and mixing and the coating may effect the releasse of drug from tablet.