In dissolution test, the acceptance criteria is mentioned as different level/stage(S1, S2 &S3) and acceptance criteria as Q+5% at S1. What is rational behind this kind of test criteria for dissolution test in pharmacopoea(BP or USP)? Can we say the product complying at S2 or S3 level means product of inferior quality than product complying at S1 stage.
For better quality of product, is it good idea to keep inhouse specification for dissolution test as keeping acceptance criteria at only S1 stage and removing option for test at S2 and S3. Is this practice is accepted by regulatory authority.
Dissolution acceptance criteria is determined by clinical studies of the drug product. By dissolution you are demonstrating that the API (which controls/cures a medical condition) concentration is available. It must also comply with USP <1092> and <711>.
The regulator will be ‘estactic’ if your specification is ‘tighter’ than is required. They will have NO problems.
Saeed can answer more questions than I can. See attached;