4. Quality Control Test For Capsules
Stability Test-:
1.Sheel Intigrity test
2.Determination of shelf life
Invariability Test-:
1.Weight Variation
2. Content Uniformity
Disintrgrstion Test
Dissolution Test
Moisture Permeation Test
5. Stability Test
Shell Intigrity test-:
This test performed to
know the integrity of gelatine capsule shell
(but not to know stability of active
ingredient)
Determination of self life-:
To know the shelf life of capsule
6. Invariability Test
1.Weight Variation Test-:
In this 20 Capsules are
weight and average weight is determined.
If none of weights are less than 90% or more
than 110% of average
2. Content Uniformity-:
In this 30 capsules are
selected 10 out of which are assayed for
specified procedure if 9 of 10 are within -
*specified potency range of 85 to 115% test
passes
7. Disintegration Test
Disintegration is defined as breakdown of solid
dosage form into small particles
It is method to evaluate rate of disintegration of
capsule
Small pieces after disintegration may
aggregates forming large mass of gelatin taking
more time to dissolve
10. Moisture permeation test
1] This test is carried out to assure the
suitability of containers for
packaging of capsule. The moisture
permeating feature of capsules
packaged in
2] Single unit containers-blister pack
or strip pack
3] Unit dose containers glass or plastic
bottle is to be determined