INPROCESS QUALITY CONTROL

TEST : CAPSULES
PRESENTED BY: ROHIT JAISWAL
ABHIJEET KOKATE
DEFINATION & TYPE OF CAPSULES
CAPSULES: Solid Dosage forms In which
drug substance enclosed within either
hard gelatin or soft gelatin shell.
Two Types of capsules:
1. HARD GELATIN CAPSULES
2. SOFT GELATIN CAPSULES
SIZE OF CAPSULES:
IPQC TEST FOR CAPSULES
1. Content of Active Ingredient
2. Moisture permeation test
3. Stability test
4. Weight variation test
5. Content uniformity test
6. Disintegration test
7. Dissolution test
IPQC TEST FOR CAPSULES
1) Content of Active Ingredient
For this test a sample of the contents is assayed as
described in individual monographs and calculates
the amount of active ingredient in each capsule.
IP limits for content of active ingredients
IPQC TEST FOR CAPSULES
2)Moisture Permeation Test
The USP requires determination of the moisture
permeation characteristics of single-unit and unit
dose containers to ensure their suitability for
packaging capsules.
Any change in color indicates absorption of
moisture.
By measuring pre-test weight and protest
weight of pellet, amount can be calculated.
IPQC TEST FOR CAPSULES
3) Stability Test
The capsule manufacturers routinely conduct
accelerated physical stability tests on all new
capsule products as an integral part of the product
development program.
Stability tests have proved adequate for determining
determining the effect of the capsule shell content on
the gelatin shell.
IPQC TEST FOR CAPSULES
4)Weight variation test
It is done by 20 capsules individually weighed and
average weight is determined.
If 2 capsules fall outside range of 10%of the average
then take weigh of another 40 capsules & determine
average of 60 capsules test requirement are met if 6
capsules falls outside of 10% and none of 6 capsules
outside 25% range.
IPQC TEST FOR CAPSULES
5)CONTENT UNIFORMITY TEST
 It is done by taking 10 capsules & assay each
individually by specified procedure , if 9 out of 10
within the requirement of ± 15% (85%-115%) limits and
the tenth capsule is not outside ± 25% (75%-125%) so
the batch should be accepted.
While if 2 capsules out of 10 fall outside the range
±15% so take 20 capsules and assay them individually
and take the average of 30 capsules, so the
requirements are met if 27 capsules in the ±15% range
and only 3 capsules in the ± 25% range
IPQC TEST FOR CAPSULES
6) Disintegration test
› The disintegration test determines whether capsules disintegrated with a prescribed time
when placed in a liquid medium under the prescribed integral condition.
METHOD-
› According to BP and which applies to both hard and soft capsules.
1. Introduce one capsule in each tube and suspend the apparatus in a beaker containing
specified media at 37 °C- if hard capsules float on the surface, the disc may be added.
2. Operate the apparatus for 28 to 32 cycle per minute .
3. The capsules pass the test ,
• No residue remaining at the screen of the apparatus or,
• If residue remains it consist of fragment shells.
• If soft mass with no palpable core.
• If the disc is used any residue is remaining on its lower surface should only consist of
fragments of shell.
IPQC TEST FOR CAPSULES
According to IP, the disintegration test is not applicable to
modified-release capsules.
IPQC TEST FOR CAPSULES
7) Dissolution test
 The dissolution test is carried out using the dissolution
apparatus official in both the USP and IP.
The capsule is placed in a basket , and the basket is
immersed in the dissolution medium and caused to rotate
at specified speed.
The dissolution medium is held in a covered 1000 ml glass
vessel and maintained at 37 °C ± 0.5 °C by means of a
constant temperature suitable water bath.
The stirrer speed and type of dissolution medium are
specified in the individual monograph
BP, USP, and JP acceptance criteria for dissolution test of
capsule .
Reference
Asian Journal of Pharmaceutical Research and Development:
COMPARATIVE STUDY OF IN-PROCESS AND FINISHED
PRODUCTS QUALITY CONTROL TEST FOR TABLET AND
CAPSULES ACCORDING TO PHARMACOPOEIAS
In-Process and Finished Products Quality Control
Tests for Pharmaceutical Capsules According to
Pharmacopoeias : British journal of Pharmaceutical
research