General Test Procedure for Disintegration Test for Tablets and Capsules

PURPOSE
To lay down the procedure for the Disintegration test of Tablets and Capsules.

APPARATUS
DT apparatus

REAGENTS
NA

PROCEDURE
  • Take one tablet or capsule into each tube and add a disc to each tube.
  • Fill the beaker with specified liquid as per the individual test procedure.
  • Suspend the assembly in the beaker.
  • Run the apparatus for the specified time and remove the assembly from the liquid.
  • If all of the tablets or capsules disintegrated the test is passed.
  • If 1 or 2 tablets or capsules fail to disintegrate repeat the test on 12 more tablets or capsules.
  • Not less than 16 of the total 18 tablets or capsules should disintegrate.
  • If the tablet or capsule adheres to the disc and fails to comply, repeat the test without discs.
  • If all the tablets or capsules in the repeat test disintegrated the test is passed.

REFERENCES
BP 2021

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