Title: Standard operating procedure of
Disintegration test for capsules.
1.0
OBJECTIVE:
To lay down a procedure of Disintegration
test for capsules.
2.0
SCOPE:
This SOP shall be applicable to Q.C
Dept.
3.0
RESPONSIBILITY:
3.1
Doing: Q.C Analyst.
3.2
Checking: Q.C-Manager.
4.0
ACCOUNTABILITY:
4.1
Head of the Q.C Department.
5.0
MATERIAL AND EQUIPMENT:
5.1
Disintegration Apparatus.
5.2
Glassware (according to requirement).
5.3
18 dosage units.
5.4
Immersion fluid (according to requirement).
6.0
PROCEDURE:
6.1
Assemble the Disintegration Apparatus.
6.2
Switch ON the main supply of Disintegration Apparatus.
6.3
Operate the Disintegration Apparatus according to the SOP.
6.4
Use water as a
medium, maintained at 37±2oC and frequency rate between 29-32
cycles/min. Take 900ml of water in beaker.
6.5
Take 6 dosage-units. Place a removable wire cloth.
6.6
Place 1 dosage unit in each of the 6 tubes of the basket
along with the perforated plastic discs.
6.7
Set the basket in motion.
6.8
At the end of specified time, lift the basket from the fluid
and observe the dosage units: all of the dosage units must have disintegrated
completely.
6.9
If test fails then perform on additional 12 capsules. After
that it must meet the specifications of B.P, if not then batch will be fail.
6.10 Limit:
6.10.1 All of the dosage units must disintegrate completely. If 1
or 2 dosage units fail to disintegrate, repeat the test on 12 additional dosage
units.
6.10.2 The requirement of the test met if not less than 16 of the
18 dosage units tested have disintegrated.
Note: Same procedure of test will be performed
on both hard gelatin capsules and soft gelatin capsules.
7.0
REVISION LOG:
|
Revision No. |
Effective Date |
Reason |
|
00 |
|
New
SOP |
8.0
REFERENCES:
8.1
The British Pharmacopoeia. Vol V., Official Monograph / Disintegration Apparatus: 2015, pp. 346-348.
8.2
USP38NF33 Volume-1 Official Monograph/ Physical
test and determination: <701>Disintegration test: 2015, pp.: 483-485.
9.0
ANNEXURES:
Annexure
1: Observation.
Annexure: 1
Observation
Total
No. of capsules: _________
|
Parameter
|
Result
|
Inference
|
|
Disintegration time |
|
|
Comment:
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