How many runs have to be performed for the Performance Verification Test?
USP’s current approach for the PVT calls for the performance of two consecutive runs including all positions of a dissolution instrument (Single-Stage Test approach). The combined results for both runs will be evaluated and compared with the acceptance criteria corresponding to the Single-Stage approach. Moreover, USP has implemented a Two-Stage Test approach that allows the analyst to evaluate the results of the first run and compare it with the acceptance criteria corresponding to the first stage (run) of the Two-Stage approach. If the results are within the first-stage acceptance criteria, the PVT test can be stopped at this stage. In case of an assembly with 12 positions, a single run (with all positions tested) is required for the PVT.
Related Questions
- Can the manufacturer of an ASR help with the validation and verification of performance specifications of a test that utilizes its ASR?
- How is a home performance test different from the Internet energy surveys and audits performed by the utility company?
- Is the Calculation Tool for the Performance Verification Test (PVT) of Dissolution Assemblies validated?
