LimsPulse
Dosage-form testing

Disintegration Test Apparatus

Checks whether tablets or capsules break up within a stated time when moved up and down in a liquid at 37 °C. A quick, routine test for release and in-process control.

  • Pharmaceutical
  • Nutraceuticals and dietary supplements
  • Veterinary medicines
  • Contract testing labs
Illustration of Disintegration Test Apparatus
Follow your site SOP
This is a typical operating sequence for learning. Your instrument model and approved SOP take precedence.
STAGE 1

Before you start

  1. 1Check the calibration status label and the bath water level.
  2. 2Inspect the mesh for tears, corrosion or blockage and check the tubes are clean and intact.
  3. 3Confirm the method: immersion fluid, temperature, time limit and whether discs are used.
  • A damaged mesh lets fragments fall through early and gives a false pass. Replace it before testing.
STAGE 2

Running the test

  1. 1Fill the beaker with the specified fluid and allow it to reach 37 ± 2 °C; check with a calibrated thermometer.
  2. 2Hang the basket-rack assembly on the drive arm and confirm the mesh is below the surface at the top of the stroke.
  3. 3Place one unit in each of the six tubes and add discs if required.
  4. 4Start the apparatus and the timer together.
  5. 5Observe the units through the test and record the time at which each has completely disintegrated, or record the state at the stated time limit.
  • Do not add discs unless the monograph calls for them; they can make a borderline batch pass.
STAGE 3

Evaluation

  1. 1If all six units disintegrate within the time limit, the test passes.
  2. 2If one or two units fail, repeat the test on a further twelve units, as the pharmacopoeia allows; the batch passes if the stated number out of eighteen (commonly not fewer than 16) have disintegrated.
  3. 3For enteric-coated units, apply the acid stage and buffer stage criteria exactly as written in the monograph.
  • Record unusual behaviour such as sticking to the mesh, floating or capsule shells that do not rupture.
STAGE 4

Shutdown

  1. 1Remove the rack, empty the beaker and rinse the tubes, mesh and discs with purified water.
  2. 2Dry the parts and store the rack hanging or supported so the mesh is not damaged.
  3. 3Complete the usage log.
In LimsPulse · Calibration Management

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

See how