A dissolution method with discriminatory power ensures it can detect critical differences in formulation or process that may impact drug release.
On the other hand, the Q-point specification defines the acceptance criteria (e.g., Q = 80% in 30 minutes) to guarantee consistent and reproducible drug release across batches.
The relation?
- Without discriminatory power, the Q-point is just a number.
- With discriminatory power, the Q-point becomes meaningful—ensuring that the set specification truly reflects product quality, robustness, and in-vivo performance.
In short, discriminatory power validates the relevance of the Q-point, and the Q-point provides a measurable standard for dissolution quality.
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Resource Person: Vijay Agrawal