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If Q has been set as 75% of dissolved active substance, the acceptance criteria would be as follows:

6 dosage units are tested:

- Acceptance criterion at level S1: each of the 6 dosage units tested is not less than 80%.

If the result does not conform, a further 6 dosage units are tested:

- Acceptance criterion at level S2: the average of the 12 dosage units tested in levels S1 and S2 is equal to or greater than 75%, and no dosage unit is less than 60%.

If the result still does not conform, a further 12 dosage units are tested:

- Acceptance criterion at level S3: the average of the 24 dosage units tested in levels S1, S2 and S3 is equal to or greater than 75%, not more than 2 dosage units are less than 60%, and no dosage unit is less than 50%.


If the result still does not conform the test would be considered as failed.

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