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
CALIBRATION

Dissolution tester calibration procedures

Mechanical calibration (shaft, vessel, centring)

Measures the physical set-up of every position: shaft wobble, shaft and vessel verticality, centring of the shaft in the vessel, and the height of the paddle or basket above the vessel bottom.

Open procedure

Rotation speed

Checks that every shaft turns at the set speed, using a calibrated tachometer, at the speeds your methods use.

Open procedure

Temperature

Confirms the medium in every vessel is held at 37 ± 0.5 °C, using a calibrated thermometer.

Open 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.

Open procedure
QUALIFICATION

Instrument qualification (DQ · IQ · OQ · PQ)

  1. 01

    DQ — Design qualification

    States the lab's needs (apparatus types, number of positions, speed range, temperature control, auto-sampling, data integrity of the controller) and confirms the selected model meets compendial dimensional requirements.

  2. 02

    IQ — Installation qualification

    Confirms delivery and installation: serial numbers, vessels, paddles and baskets with their certificates of dimensions, a level and vibration-free bench, utilities and documentation.

  3. 03

    OQ — Operational qualification

    Checks speed, temperature, shaft wobble, shaft and vessel verticality, centring and paddle or basket height at every position, plus timer and auto-sampler functions.

  4. 04

    PQ — Performance qualification

    Shows the system performs for its intended use, through a performance verification test with reference tablets and/or a documented enhanced mechanical calibration, as your SOP requires.

In LimsPulse · Calibration Management

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

See how