Dear All,
Want to know, what is 3 level acceptance criteria of dissolution i.e S1/S2/S3 or L1/L2/L3.
Also want to know, what is F1 and F2 value.
Regards
Prashant Mhetre
about 3 level acceptance criteria:
if it is conformed to the criteria (using 6 units), i.e., each unit is not less than Q+5%, it means that your product is passed and the test is finished.
if it is not met that criteria, i.e, there is one or more units that fall below Q+5%, you could continue the test using 6 additional units. this is stage 2. in this stage, calculate the average all of 12 units (6 from S1 + 6 from S2). average of 12 units (S1 + S2) should be equal to or greater than Q, and no unit is less than Q-15%. if it is conformed to the criteria, it means that your product is passed and the test is finished.
if it is not met that criteria of stage 2, you could continue the test using 12 additional units. this is stage 3. in this stage, calculate the average all of 24 units (6 from S1, 6 from S2, and 12 from S3). average of 24 units should be equal to or greater than Q, not more than 2 units are less than Q 15%, and no unit is less than Q 25%. if it is conformed to the criteria, it means that your product is passed. otherwise, your product is failed.
for f1 and f2 value, please read the ICH Guidance for Industry: Dissolution Testing of Immediate Release Oral Dosage Forms. you could download the guidance from FDA’s website for free.