Title: Standard operating procedure of
Disintegration test for Enteric coated tablets.
1.0
OBJECTIVE:
To lay down a procedure of Disintegration
test for enteric coated tablets.
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
Take 6 dosage-units.
6.5
Place 1 dosage unit in each of the 6 tubes of the basket
along with the perforated plastic discs.
6.6
If the tablet has the soluble external sugar coating,
immerse the basket in water at room temperature for 5 minutes before operating
the apparatus.
6.7
Take 900ml of simulated gastric fluid in beaker.
6.8
Use simulated gastric
fluid, maintained at 37±2oC and frequency rate between 29-32
cycles/min.
6.9
Place 1 dosage unit in each of the 6 tubes of the basket in
beaker.
6.10
Set the basket in motion for 1 hour.
6.11
After 1 hour of operation in simulated gastric fluid, lift
the basket from the fluid and observe the tablets: the tablet shows no evidence
of disintegration, cracking or softening.
6.12
Remove the gastric fluid for the beaker and wash it
properly.
6.13
Add simulated intestinal fluid in beaker up to 900ml.
6.14
Operate the apparatus, using simulated intestinal fluid,
maintained at 37±2oC and frequency rate between 29-32 cycles/min for
the time specified in the monograph (or when the tablets are completely
disintegrate).
6.15
Lift the basket from the fluid, and observe the tablets: all
the tablets disintegrate completely.
6.16
If 1 or 2 tablets fail to disintegrate completely, repeat
the test on additional 12 tablets.
6.17
After that it must meet the specifications of B.P, if not
then batch will be fail.
6.18
Limit:
6.18.1
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.
6.18.2
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 delayed release tablets.
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 enteric coated tablets: ______________
Simulated
gastric fluid used: ___________________
|
Remarks: The
tablet shows no evidence of disintegration, cracking or softening. |
Yes
|
No
|
Simulated
intestinal fluid used: _________________
|
Parameter
|
Result
|
Inference
|
|
Disintegration time |
|
|
Comment:
____________________________________________________