LimsPulse
Dosage-form testing

Dissolution Test Apparatus

Measures how fast and how completely the drug is released from a tablet or capsule into a liquid medium held at body temperature. A key quality and release test for oral solid dosage forms.

  • Pharmaceutical
  • Generic drug development
  • Nutraceuticals and dietary supplements
  • Veterinary medicines
  • Contract research and testing labs
Photo of a Dissolution Test Apparatus
Photo: Gpkp, CC BY-SA 4.0 (cropped), via Wikimedia Commons
TROUBLESHOOTING

Common problems, causes and fixes

Results lower than expected or highly variable
Likely causes
  • • Dissolved air forming bubbles on the unit or basket
  • • Coning of powder under the paddle
  • • Vessel not centred or shaft wobbling
  • • Incorrect paddle or basket height
What to do
  • • Deaerate the medium as per the method
  • • Confirm coning is real and discuss with method owners (the method, not the analyst, decides on changes)
  • • Recheck centring, wobble and height
  • • Repeat the mechanical calibration
One vessel always gives different results
Likely causes
  • • Scratched or deformed vessel
  • • Damaged paddle or bent shaft at that position
  • • Vessel not seated in its centring ring
  • • Local temperature difference
What to do
  • • Swap the vessel and paddle to another position to find the cause
  • • Replace the damaged part
  • • Check temperature in that vessel with a calibrated probe
Results higher than expected
Likely causes
  • • Vibration from nearby equipment or a worn drive
  • • Sampling too close to the paddle
  • • Rotation speed too high
  • • Evaporation of medium without covers
What to do
  • • Isolate the bench from vibration sources
  • • Use the correct sampling position
  • • Verify speed with a tachometer
  • • Use vessel covers
Temperature out of range
Likely causes
  • • Low bath water level
  • • Heater or circulator fault
  • • Medium added cold
  • • Faulty temperature sensor
What to do
  • • Top up the bath
  • • Service the heater or pump
  • • Pre-warm the medium
  • • Check the sensor against a calibrated thermometer
Units floating
Likely causes
  • • Capsule shells trapping air
  • • Low-density formulation
What to do
  • • Use the sinker type specified or permitted by the method
  • • Use the basket apparatus only if the method allows it
Filter blocked or slow sampling
Likely causes
  • • High excipient load
  • • Unsuitable filter pore size or material
What to do
  • • Use the validated filter and pre-filter if the method allows
  • • Check filter compatibility and adsorption during validation
Failed performance verification test
Likely causes
  • • Mechanical parameters at the edge of tolerance
  • • Poor deaeration
  • • Vibration
  • • Analyst technique (timing, sampling, filtration)
What to do
  • • Repeat the mechanical checks
  • • Review deaeration and sampling
  • • Investigate as per your SOP before repeating; do not just retest until it passes
In LimsPulse · Calibration Management

Keep every Dissolution tester in control: usage logs, calibration and maintenance schedules, and automatic blocking of overdue instruments.

See how