This summary relates to a recent webinar event produced by Separation Science, in collaboration with USP.
Dissolution testing assesses how effectively a tablet releases its active ingredient, a key measure for regulators to determine product quality and batch release. However, the test only works if the system behind it is stable.
To manage variability, many labs focus on enhanced mechanical calibration. These procedures verify shaft alignment, vessel symmetry, and rotation speed; factors that affect physical consistency. Sometimes this focus can lead labs into the trap of relying on mechanical calibration instead of conducting full system qualification, thereby overlooking the critical role of USP performance verification testing (PVT).
The summary explores the risks laboratories face when viewing calibration and qualification as mutually exclusive steps, emphasizing the importance of applying both to achieve reliable data, consistent system performance, and sustained regulatory confidence.
Download this executive overview to understand these critical points about dissolution testing:
- Mechanical calibration and PVT are both essential for a fully qualified dissolution instrument.
- The new DPVS formulation is highly sensitive to subtle changes and interactions in instrument setup and operational parameters.
- Instrument-to-instrument variability is a significant factor in dissolution performance, even among mechanically qualified systems.
- Understanding parameter interactions is critical, as individual parameters that pass mechanical calibration do not guarantee overall system performance within acceptance limits.
Meet the Expert:
 | Mark Liddell, PhD Senior Manager, Dosage Form Performance Laboratory, USP Dr. Mark Liddell is the Senior Manager of Dosage Form Performance Laboratory (DFPL) at USP’s Rockville headquarters. Mark has worked at USP for 18 years, pursuing and promoting a deeper understanding of the fundamentals of dissolution science. At USP Mark’s work has focused on improving the reliability and reproducibility of compendial dissolution and drug release test methods. DFPL is responsible for overseeing the development, manufacture, and monitoring of performance verification test (PVT) reference materials used to demonstrate the suitability of dissolution testing apparatuses. Mark also supports USP education course offerings, reference standard technical services, the USP Dosage Form expert committee, the USP Performance Verification Testing expert panel, and various other internal and external stakeholders as a dissolution/drug release testing subject matter expert. Mark’s journey spans over 25 years, dedicated to refining in vitro test methods for dosage forms and drug delivery systems. |
