A batch of immediate-release tablets has a dissolution speci…
A batch of immediate-release tablets has a dissolution specification of Q = 80 % in 30 minutes: (15)The % dissolved at 30 minutes is measured as follows: Tablet % Dissolved S1 (6 tablets) 82, 79, 84, 81, 78, 80 S2 (6 tablets) 83, 85, 79, 80, 81, 82 S3 (12 tablets) 80, 79, 81, 82, 78, 83, 80, 81, 82, 80, 79, 81 Tasks:Calculate the mean % dissolved at tier (S2, S3 as required).Determine whether and at what stage the batch meets the dissolution specification.Explain the regulatory implications of your findings at each tier.
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