STANDARD OPERATING PROCEDURE LAB EQUIPMENT DISINTEGRATION TEST APPARATUS

 STANDARD OPERATING PROCEDURE

SUBJECT :                     LAB EQUIPMENT DISINTEGRATION TEST APPARATUS

DEPARTMENT           : QA SOP NO.                      : Page No                       : Effective Date             : Next Review                : SOP REVISION           :

1.0       OBJECTIVE:

To provide guidelines for checking Disintegration of Tablets.

2.0       POLICY:  

To lay down a procedure for disintegration test apparatus.

3.0       PROCEDURE:

Disintegration Test for Tablets

This method is provided to determine whether uncoated tablets disintegration within a prescribed time when placed in a liquid medium under the prescribed experimental conditions. The test is not applicable to sustained release tablets. For the purpose of this, disintegration does not imply complete solution of the tablets or even the its active constituent .Disintegration is defined as the state in which any residue of the tablet, except fragments of insoluble coating remaining on the screen of the test apparatus consists of a soft mass having no palpably  firm, unmoistened core.

Description

This apparatus consists of a rigid basket rack assembly supporting six cylindrical tubes placed vertically, having SS woven gauge of 2.00 mm aperture at the bottom. These cylindrical tubes are provided with transparent cylindrical discs. The basket rack assembly is attached to a mechanical device which can raise and lower the basket rack assembly at a constant frequency of between 28 & 32 cycles per minute. The basket rack assembly is suspended in the liquid medium in a 1000ml beaker. The volume of liquid is such that the wire mesh at its highest point is at least 25mm below the surface of the liquid and its lowest point is at least 25mm above the bottom of the beaker. A thermostatic arrangement maintaining the temperature between 35 & 39ºC.

Method

1. Uncoated tablets

Unless otherwise stated in the individual monograph place one tablet in each of the six tubes of the basket, add a disc to each tube, and operate the apparatus, using water maintained at 37 +/- 2 deg. C as the

                                               

immersion liquid. At fifteen minutes or the times specified in the individual monograph, lift the basket from

the liquid and observe the tablets. The tablets pass the test if all six tablets have disintegrated. If one or two tablets fail to disintegrate, repeat the test on twelve additional tablets, not less than sixteen tablets of the total of eighteen tablets tested disintegrate.

4.0       FREQUENCY:  Calibrated once in 3 months and record is maintained.

5.0       RESPONSIBILITY: Executive Q.A.

6.0       REVIEW GUIDE: Calibration register.

7.0       ANNEXURE: -------

8.0       SOPs DISTRIBUTION:

            This SOP shall be distributed to following Departments:

Name of the Department	Master Copy	Circulatory Copy
QA/QC	√	√
Production	x	x
Warehouse	x	x
General	x	x
Maintenance	x	x