Title: Standard operating procedure of
Disintegration test for Gastro-resistant capsules/ Delayed release capsules.
1.0
OBJECTIVE:
To lay down a procedure of Disintegration
test for Gastro-resistant capsules/ Delayed release 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 1 (0.1M Hydrochloric acid).
5.5
Immersion fluid 2 (phosphate buffer solution pH 6.8).
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, if prescribed.
6.6
Take 900ml of simulated gastric fluid (0.1M HCl) in beaker.
6.7
Use simulated gastric fluid, maintained at 37±2oC
and frequency rate between 29-32 cycles/min.
6.8
Place 1 dosage unit in each of the 6 tubes of the basket in
beaker.
6.9
Set the basket in motion for 2 hour, without the disc.
6.10 After 2 hour of operation in simulated
gastric fluid, lift the basket from the fluid and observe the capsules: the capsules
show no evidence of disintegration, cracking or softening.
6.11 Remove the gastric fluid for the beaker
and wash it properly.
6.12 Add simulated intestinal fluid (phosphate
buffer solution pH 6.8) in beaker up to 900ml. Add a disc to each tube.
6.13 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 capsules
are completely disintegrate; approx. 60min).
6.14 Lift the basket from the fluid, and
observe the capsules: all the capsules disintegrate completely.
6.15 If 1 or 2 capsules fail to disintegrate
completely, repeat the test on additional 12 capsules.
6.16 After that it must meet the
specifications of B.P, if not then batch will be fail.
6.17 Limit:
6.17.1
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.
6.17.2
The requirement of the test met if not less than 16 of the
18 dosage units tested have disintegrated.
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 delayed release capsules: ______________
Simulated
gastric fluid used: ___________________
|
Remarks: The
capsules show no evidence of disintegration, cracking or softening. |
Yes
|
No
|
Simulated
intestinal fluid used: _________________
|
Parameter
|
Result
|
Inference
|
|
Disintegration time |
|
|
Comment:
____________________________________________________
________________________________________________________________________________________________________