The USP Performance Verification Test (PVT) assesses the suitability and performance of apparatus used in dissolution testing. This assures that a dissolution test produces results about the drug product, not the test equipment. As such, the PVT in USP General Chapter <711> Dissolution is a core building block of quality testing and standardized manufacturing. The holistic PVT covers mechanical, chemical, and analytical aspects of apparatus suitability as it produces dissolution samples from a standardized material—the Prednisone Tablets Reference Standard (RS).*
By using standardized materials and procedures, your laboratory can compare results from your instrument with other laboratories worldwide. Failing results may indicate the faulty operation of the dissolution assembly, deviation from the correct procedure, or an error due to the analyst conducting the test. As a global standard, PVT limits lab-to-lab variability. To minimize that variability, USP requires that internationally participating labs follow a rigorous protocol that includes documentation of the use of mechanical calibration standards.
*Prednisone is a synthetic corticosteroid. Due to its uniform disintegration, the official USP Prednisone tablets RS is the only standard designed, developed, and validated for use with the USP PVT. Each lot of USP prednisone tablets must be evaluated to ensure the percentage of drug released falls within a pre-established range (geometric mean and %CV).