80% (Q) in dissolution testing represents a target for the amount of drug that should be dissolved from a solid dosage form within a specified time, expressed as a percentage of the label claim.
According to the provided reference, Q represents the amount of dissolved active ingredient specified in the individual monograph, expressed as a percentage of the label claim. A typical Q specification is in the range of 70% to 80%, and a Q value exceeding 80% is not generally used.
Here's a breakdown:
- Q: Represents the amount of drug dissolved, expressed as a percentage of the label claim.
- 80% (Q): Means that 80% of the drug, as stated on the label, must be dissolved within the timeframe defined in the dissolution test. This value acts as an acceptance criterion. If the dissolution test result for a batch consistently meets or exceeds 80% (Q) within the allotted time, then the batch passes the dissolution requirements. If it does not, further investigation is required.
For Example:
Suppose a tablet contains 100 mg of a drug, and the dissolution test requires Q = 80% at 30 minutes. This means that 80 mg of the drug from the tablet must dissolve within 30 minutes for the tablet to meet the dissolution specifications.
