Dissolution Performance Verification Standard-
The new standard for PVT
Dissolution testing apparatus are designed to create an environment similar to the in-vivo conditions of the human system. These apparatus are used to study the release of the drug from the formulation when exposed to the bio-similar conditions. Dissolution testing helps in evaluating the release rate of API, Bio-availability and overall physical and chemical performance of a Formulation
So it becomes very imperative and necessary that the dissolution test apparatus itself meets the specifications laid by the USP to obtain reliable and reproducible results.
Get your dissolution tester certified for PVT by our trained Dissolution experts for PVT
PVT assist (Performance Verification Test Assistance as per USP recommendations)
IQ procedures by qualified engineer/toolkit
Analytical Instrument Qualification
Design Qualification – According to the instrument’s intended use, design qualification (DQ) is a set of actions that are documented and that specify the functional and operational requirements of the instrument as well as the criteria for choosing the vendor.
Installation Qualification- Installation qualification (IQ) is the documented collection of activities necessary to establish that an instrument is delivered as designed and specified, and is properly installed in the selected environment, and that this environment is suitable for the instrument.
Operational qualification – After a successful IQ, the instrument is ready for OQ testing. Operational qualification (OQ) is the documented collection of activities necessary to demonstrate that an instrument will function according to its operational in the selected environment.
Performance Qualification – Performance Qualification of the USP Apparatus 1 and Apparatus 2 is determined by the Performance Verification Test (PVT) using the USP Dissolution Performance Verification Standard.
Why choose Electrolab PVT assist?
Enhanced mechanical calibration of the dissolution apparatus
Usage of Standard Operating Procedures to maximize the probability of success of PVT
PVT performance and documentation by the specialist
ELECTROLAB Certificate of apparatus compliance
Tale of Innovation and Delight
The tale of the Electrolab India Dissolution Performance Verification Standard became a testament to the power of innovation, dedication, and the joy of infusing fun into our endeavors. We proved that even the most serious pursuits can be transformed into delightful experiences that push the boundaries of what is possible.
So, join us on this extraordinary journey as we continue to pioneer new frontiers, leaving an everlasting legacy of scientific marvel and enchantment. Together, let us embrace a world where innovation and delight dance hand in hand, forever changing the landscape of scientific exploration.
What is PVT?
The PVT using the USP Dissolution Performance Verification Standard – Prednisone Reference Standard (RS) (catalog #1222818) is a holistic test that demonstrates the operation of the entire assembly setup as it produces dissolution results that can be compared to established acceptance criteria.
Difference between PVT and mechanical calibration?
Mechanical calibration is a procedure to verify the fixed parameters for the instrument, e.g., vessel, paddle, basket, etc., and instrument function, e.g., rotation speed, temperature control, etc. Mechanical calibration alone cannot satisfy the Performance Qualification (PQ) component of the dissolution assembly qualification.
Purpose of PVT?
The purpose of the PVT is to provide evidence of instrument and apparatus suitability. USP considers adherence to measurable, dimensional, and operational parameters to be a critical component of dissolution apparatus suitability. However, without a challenge to the apparatus demonstrating the ability to produce dissolution results from a standard material, mechanical calibration alone cannot provide sufficient evidence that the apparatus is performing satisfactorily. The purpose of the PVT is not to diagnose specific problems with the dissolution assembly but to provide confidence that the instrument is functioning properly.
Can we use old Prednisone tablets for PVT?
No. As of 1st May 2023, USP Dissolution Performance Verification Standard – Prednisone RS and USP Prednisone RS is the official formulation for Performance Verification Test of USP Apparatus 1 and USP Apparatus 2.
Do we have to perform PVT again if we have already calibrated our instrument before 01 May 2023 using the old Prednisone tablets?
No. If you have already calibrated your instrument before 01 May 2023 using the old USP Prednisone tablets then there is no need to perform the PVT again until your next calibration schedule. But any PVT done after 01 May 2023 should be performed using the new USP Dissolution Performance Verification Standard.