[qc2 lab] m2.3 - product testing of drug sample

Disintegration Test

Determine whether tablets, capsules, or granules disintegrate within the prescribed time when placed in a liquid medium

complete solution

disintegration does not imply _____ of the unit or even of its active constituent

Complete disintegration

* state in which %%__***any residue***__%% of the unit, ***except* __*fragments*__** of insoluble coating
* or capsule shell, %%__***remaining on the screen***__%% of the test apparatus or adhering to the lower surface of the disk, if used,
* is a %%__***soft mass***__%% having no palpably firm core

Basket -rack Assembly

* __***6 open -ended transparent tubes***__
* the tubes are held in a %%***vertical position***%% by __***two plates***__
* __***10 -mesh wire cloth***__ at the bottom

Cylindrical Disks

* permitted __***only where specified or allowed in the monograph***__
* prevents the sample from coming out of the assembly

Disintegration Media (Immersion Fluids)

1. Distilled water
2. 0.1 HCl
3. Simulated Gastric Fluid TS
4. Simulated Instestinal Fluid TS

Criteria: For Uncoated or Plain-Coated Tablets

1. If **6 tablets** are tested, __***all 6 of the tablets are disintegrated***__.
2. If __***18 tablets are tested***__, the requirement is met if __***not fewer than 16 of the total of 18 tablets***__ are disintegrated