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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