Dissolution tester · Calibration procedure
Temperature
Confirms the medium in every vessel is held at 37 ± 0.5 °C, using a calibrated thermometer.
PURPOSE
Why this is checked
Solubility and dissolution rate increase with temperature. A vessel that runs warm or cool gives a biased result.
Frequency
Typically every 6 months for the built-in sensors; the medium temperature is also checked at each test.
Learn how the Dissolution tester worksYOU WILL NEED
Standards & tools
- Calibrated digital thermometer or probe with 0.1 °C resolution, traceable to national standards
BEFORE YOU START
Prerequisites
- Vessels filled with the usual volume of water or medium
- Bath at set temperature for at least 30 minutes
- Paddles rotating at a routine speed if your SOP requires
PROCEDURE
Step by step
- 1Set the bath to 37.0 °C and let it stabilise.
- 2Place the calibrated probe in the medium of each vessel, roughly in the sampling zone.
- 3Wait for the reading to stabilise and record it, together with the instrument's displayed value.
- 4Repeat for all positions.
RECORD
Example observation table
| Position | Set (°C) | Observed (°C) | Difference (°C) |
|---|---|---|---|
| 1 | 37.0 | 37.1 | +0.1 |
| 2 | 37.0 | 36.9 | −0.1 |
| 3 | 37.0 | 37.2 | +0.2 |
| 4 | 37.0 | 37.0 | 0.0 |
| 5 | 37.0 | 37.3 | +0.3 |
| 6 | 37.0 | 36.8 | −0.2 |
CALCULATION
How to calculate the result
Difference = Observed − Set
- Position 5 observed 37.3 °C
- Difference = 37.3 − 37.0 = +0.3 °C (within ±0.5 °C)
ACCEPTANCE CRITERIA
Pass if
- Medium temperature in each vessel 37 ± 0.5 °C (or the temperature stated in the method).
IF IT FAILS
What to do
- Check bath level, circulation and heater.
- Check the built-in sensors against the reference thermometer and adjust if allowed.
- Do not use the apparatus until it passes.
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.