Acceptance criteria for Dissolution ?

Pharmabeej Pro
1y

The dissolution test has been performed in 3 stages. If 1st stage (S1) fails then proceeded for 2nd (S2) and If it's fail then 3rd (3rd).

For every dissolution stage there is different acceptance criteria.

For Stage 1 (S1): Analysing 6 units and each unit should be equal to or greater than Q+5.

For Stage 2 (S2): Analysed another 6units, and the average of 12 units (S1+S2), should be equal or greater than Q value and no unit is less than Q-15.

For Stage 3 (S3): Analyzed another 12 units and average of 24 units (S1+S2+S3) should be equal or greater than Q value and not more than 2 units are less than Q-15 and no unit is less than Q-25.

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