Module 3 2019

How do we set acceptance criteria?

For Example: Drug Product Performance

Dissolution performed in pH 6.8 Phosphate Buffer on stability – no changes on storage

Disintegration performed on stability – rapid disintegration with no change on storage

Specification set to control Disintegration time in lieu of dissolution

● Possible when certain prerequisites are met – high solubility, high permeability and rapid dissolution – link between dissolution and disintegration

Even when these prerequisites are not met it may still be possible to not perform dissolution routinely …

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