Study Set Content:
Put the tablet in the apparatus in water or HCL for
30 min at 37oC
Put the tablet in the apparatus in water or HCL for 30 min at 37oC. If its does not disintegrated, put in the
intestinal fluid
. If 1 or 2 fail to disintegrate, repeat on
12 tablets
6 tablets from 18 must completely disintegrate within time, if two or more does not disintegrate, the batch must be
rejected
LIMITS FOR UNCOATED TABLETS
According to USP
Simulated gastric fluid
According to BP
water
According to USP and BP temp.
37°C
According to USP Time limit
Not exceed 30 min
According to BP
Not exceed 15 min
Introduce one capsule into each tube and suspend the apparatus in a beaker containing
600ml water at 37oC
f hard capsules float on the surface of water, the (blank) may be added.
discs
Operate the apparatus for (blank) ; remove the assembly from the liquid
30 min
The Capsules pass the test if:
No residue remains on the screen of the apparatus or, If residue remains, it consists of fragments of shell
Basket-rack assembly
Basket-rack assembly apparatus B
Apparatus A
Apparatus B
Top view Disk
Side view Disk
Bottom view disk
