The purpose of this document is to carry out the operation of the Dissolution Test Apparatus.
2.0 SCOPE
This procedure is applicable to the Dissolution Test Apparatus used in Quality Control Laboratory.
3.0 RESPONSIBILITY
Chemists/analysts are responsible for following this procedure. The department In-charge/QA/Quality Manager is responsible for implementing this procedure.
4.0 INSTRUMENTS DETAILS
Name of Instrument: Dissolution Test Apparatus
Make: Manufacturer Name
Instrument Identification No. :
5.0 PROCEDURE
5.1 Fix the paddle or basket as per the test requirement.
5.2 Start the stirrer by pressing the RUN switch.
5.3 Set the RPM by turning the RPM knob clockwise to increase the RPM and anti-clockwise to decrease the RPM.
5.4 After setting the RPM, lock the knob and stop the stirrer by pressing the reset switch.
5.5 Set the time as per requirement by using a thumb wheel switch.
5.6 Select the mode using the auto manual switch. This switch illuminates in auto mode. In auto mode, the instrument will give an alarm after every set interval and the stirrer will keep on running.
5.7 Add the required volume of the deaerated dissolution medium in the jars as per required,
5.8 Bring the stirrer unit down by using the up–stop–down switch. Run the apparatus to equilibrate the dissolution medium in the jars and check the temperature with a calibrated thermometer.
5.9 If baskets are used, lift the stirrer unit, down by using up – stop – down switch. If a paddle is used, place one tablet/capsule in the jar.
5.10 The inside distance between the paddle or basket to the jars should be maintained at 25mm +2mm, during the test.
5.11 Cover the jars containing dissolution medium with the lids provided.
5.12 Start the stirrer by pressing the start switch. Run the apparatus for the set time.
5.13 Collect the sample within +2% of the specified time.
5.14 Withdraw the sample from a zone midway between the surface of the dissolution medium and the top of the rotating basket or blade, not less than 1cm. From the vessel wall and filter the solution.
5.15 Lift the stirrer by using the up–stop–down switch at the end of the set time.
5.16 Switch off the Instrument.
6.0 REVISION/CHANGE HISTORY
7.0 ATTACHMENTS
Appendix-1: FLOW DIAGRAM FOR OPERATING PROCEDURE OF DISSOLUTION TEST APPARATUS
8.0 REFERENCES
END OF THE DOCUMENT
You may like to read these links:
1. List of All SOPs and Documents for the Chemistry Laboratory
2. List of All SOPs and Documents for Quality Control
3. List of All SOPs and Documents For Quality Assurance Dept.
4. List of SOPs and Documents Required to Achieve NABL Accreditation
5. List of All SOPs and Documents for Laboratory Instruments and Equipment
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