Dissolution tester · Calibration procedure
Performance verification test
Runs a dissolution test on reference tablets supplied by the pharmacopoeia (for USP, prednisone tablets RS) and compares the results with the acceptance ranges given for that lot.
PURPOSE
Why this is checked
Mechanical checks confirm the parts are set correctly; the performance verification test (PVT) checks the whole system, including deaeration, vibration, temperature and the analyst's technique, behaves as expected.
Frequency
As required by your SOP. Many labs run PVT every 6 or 12 months alongside mechanical calibration; others rely on an enhanced mechanical calibration as allowed by their quality system.
Learn how the Dissolution tester worksYOU WILL NEED
Standards & tools
- Pharmacopoeial reference tablets for PVT (e.g. USP Prednisone Tablets RS) with the certificate for the current lot
- Corresponding reference standard for analysis (e.g. prednisone RS)
- Calibrated UV-Vis spectrophotometer
BEFORE YOU START
Prerequisites
- Mechanical calibration, speed and temperature all passing
- Medium (typically deaerated water) prepared exactly as the PVT instructions state
- Analyst trained on the PVT procedure
PROCEDURE
Step by step
- 1Prepare and deaerate the medium as described in the PVT instructions.
- 2Run the test with apparatus 1 and/or apparatus 2 at the speed, volume and time stated in the instructions for the lot.
- 3Withdraw and filter samples, then measure them by UV against the reference standard.
- 4Calculate % dissolved for each vessel.
- 5Calculate the geometric mean and the % coefficient of variation (or the statistics the certificate asks for).
- 6Compare with the acceptance ranges given for that lot of reference tablets.
RECORD
Example observation table
| Vessel | % dissolved (illustrative) |
|---|---|
| 1 | 41 |
| 2 | 44 |
| 3 | 39 |
| 4 | 43 |
| 5 | 42 |
| 6 | 45 |
CALCULATION
How to calculate the result
Geometric mean = exp(mean of ln values); %CV = standard deviation ÷ mean × 100 (or the log-based CV if the certificate specifies it)
- ln values of 41, 44, 39, 43, 42, 45 averaged and back-transformed
- Geometric mean = 42.3%
- %CV (simple) = 2.16 ÷ 42.33 × 100 = 5.1%
- Compare 42.3% and 5.1% with the lot-specific ranges on the certificate (values here are illustrative only)
ACCEPTANCE CRITERIA
Pass if
- Geometric mean % dissolved and variability within the ranges stated for the current lot of reference tablets.
- Acceptance ranges change with the lot, so always use the certificate for the lot in use.
IF IT FAILS
What to do
- Do not simply repeat until it passes; investigate as per your SOP.
- Check deaeration, temperature, vibration, mechanical set-up, sampling and analytical steps.
- Correct the cause, document the investigation and repeat the PVT.
- Assess the impact on results since the last passing PVT.
MORE
Other Dissolution tester calibrations
In LimsPulse · Calibration Management
LimsPulse schedules this calibration, records the result against limits, and blocks the instrument everywhere if it fails or goes overdue.