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General Test Procedure (GTP) 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 of 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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