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
WORKING PRINCIPLE

How Disintegration tester works

The repeated up-and-down movement through the fluid at body temperature mimics gentle agitation. Water penetrates the unit, disintegrants swell and the unit breaks into small particles that pass through the mesh. The time until no firm core is left is the disintegration time.

FLOW

The path of a sample

  1. 01

    Fill beaker

    Fill the 1 L beaker with the specified immersion fluid and bring it to 37 ± 2 °C.

  2. 02

    Load units

    Place one unit in each of the six tubes; add discs if the monograph requires.

  3. 03

    Start strokes

    Start the drive so the rack moves up and down at a constant rate over a fixed distance.

  4. 04

    Observe

    Watch the units and note when each has disintegrated.

  5. 05

    Judge

    At the stated time, check that all units have disintegrated; apply the repeat rule if one or two fail.

COMPONENTS

Main parts and what they do

1

Basket-rack assembly

Six open tubes held between perforated plates with a woven stainless-steel mesh at the bottom.

2

Discs

Transparent plastic discs with holes, used on top of the units only when the monograph specifies them.

3

Immersion beaker

A 1 L low-form beaker holding the fluid, deep enough that the mesh stays below the surface at the top of the stroke and clear of the bottom at the lowest point.

4

Drive mechanism

Motor and crank or cam that move the rack up and down at a constant frequency and stroke length.

5

Water bath and heater

Keeps the immersion fluid at 37 ± 2 °C.

6

Temperature sensor and controller

Measures and controls the bath or fluid temperature.

7

Timer / display

Sets the test time and often records the end-point for each tube.

KEY CONCEPTS

Terms every analyst should know

Basket-rack assembly

Six transparent tubes held between two plates, with a stainless-steel mesh under the tubes. The whole rack moves vertically in the fluid.

Stroke frequency and distance

The rack moves through a stroke of about 53–57 mm at about 29–32 cycles per minute (typical compendial values).

Complete disintegration

No residue other than insoluble coating or capsule shell fragments, or a soft mass with no firm core, remains on the mesh.

Discs

Plastic discs placed on top of the units when the monograph says so. They help prevent floating but add mechanical force.

Enteric-coated units

Tested first in acid for a set time, during which they must show no sign of disintegration or cracking, then in buffer, in which they must disintegrate.

In LimsPulse · Calibration Management

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

See how