usp.org

PVT and Dissolution Performance
Verification Standard - Prednisone
Importance of PVT versus
mechanical alone
Product recalls due to quality issues can be costly.
They can harm patients, disrupt business
operations, may trigger regulatory investigations
and require costly remediation. They can also
damage customer confidence and lead to reduced
market share. Accurate dissolution results help
ensure patient safety and avoids recalls. Therefore,
ensuring that your dissolution apparatus is working
properly is critical.

We listened!
Dissolution Performance Verification Standard (DPVS) - Prednisonetablets have been developed to create greater reassurance in theperformance qualification of Dissolution Apparatus 1 andDissolution Apparatus 2. This will be the official standard for PVT
when the proposed revision for USP General Chapter <711>
Dissolution becomes official.
The Performance Verification Test, General Chapter <711>, is aholistic test that demonstrates the suitable operation of the entire
dissolution test assembly. DPVS – Prednisone will help ensurecomprehensive qualification of instruments using PVT, so you canbe confident of the dissolution profiles of medicines evaluatedusing apparatus 1 and 2.

Features and benefits of DPVS - Prednisone• Stable throughout its shelf-life, hence lower tablet-to-tablet
variability• Sensitive to critical changes in the setup of both apparatus 1and 2• Ball-shape of the tablet to ensure consistent positioning of
the tablet in apparatus 1 and 2• Less sensitive to media degassing, thus providing better
sensitivity to other critical operational and setup parameters• New easy-to-open blister packaging with push-throughdesign and additional sachet packaging to protect against
environmental moisture
These features improve accuracy and sensitivity, increasing yourconfidence in the dissolution system suitability. You can havepeace of mind in your instrument set-up and the PVT test using
the new DPVS - Prednisone.
08302022

Mechanical qualification alone does not provide
sufficient evidence that the apparatus is performing
satisfactorily. Mechanical calibration focuses onindividual, measurable operational parameters ofthe dissolution assembly. Performance Verification
Testing (PVT) assesses the operation of the wholeassembly, to verify that the different components
are working together properly. Both mechanicaland PVT are necessary to ensure that a dissolution
instrument is fully qualified.
A failing PVT result may be an indication of amalfunctioning dissolution bath, a dissolution
assembly that is not set up correctly, or analyst
error, among other possible sources of failing
dissolution results. The ranges for the geometricmean (GM) and the coefficient of variation (%CV)
are an integral component of the PVT and are
obtained from a multinational collaborative study
for each new lot. Those two statistics, GM and %CV,
help the laboratory using the reference standard
determine if their results are accurate andreproducible within the context of ISO 5725-6
Accuracy of Measurement Methods and Results.
Thus, the USP PVT reference standard provides abenchmark to compare dissolution test results to
those obtained by competent dissolution scientists
throughout the world.

SupportFor support on DPVS - Prednisone, please contact:
RSTech@usp.org

Empowering a healthy tomorrow