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DISINTEGRATION TEST
disintegrate within the prescribed time when placed in a liquid medium at the required
experimental conditions. The specification of this test depends on the type of tablets
and capsules, that is, troches, chewable tablet and extended-release or delayed-release
tablets or capsules.
defined as “in which any residue of the samples remaining on the screen of the test
apparatus or adhering to the lower surface of the disk (if used), is a s soft mass having
PROCEDURE:
1. Place 1 tablet in each of the six tubes of the basket, if specified, add a
disk, and operate the apparatus, using water maintained at 37⁰C+ 2⁰C as
3. Lift the basket from the fluid, stop the drive and timer, observe the tablets,
5. After the 12 additional tablets, not less than 16 of the 18 tablets tested
1. Place 1 capsule in each of the six tubes of the basket, if specified, add a
disk, and operate the apparatus, using water maintained at 37⁰C+ 2⁰C as
2. Attach a removable wire cloth. The wire cloth must have a palin square
weave with 1.8 to 2.2 mm mesh s hole opening and with a wire diameter
of 0.60 to 0.655 mm, to the surface of the upper portion of the basket –
rack assembly.
4. Lift the basket from the fluid, stop the drive and timer, and observe the
time.
6. After the 12 additional capsules, not less than 16 of the 18 capsules tested
3. After 1 hour the process in the simulated gastric fluid TS, lift the basket
from the fluid, and observe the tablets. The tablets must show no evidence
at 37 ± 2⁰.
6. Lift the basket from the fluid, stop the drive and timer, and observe the tablets.
8. After the 12 additional tablets, not less than 16 of the 18 tablets tested
Name : Date:
EXPERIMENT 15
DISINTEGRATION TEST
Disintegration Time:
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Disintegration Time:
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Disintegration Time:
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QUESTIONS: