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
Tags
GTP