General Test Procedure pH

1. Purpose
   1. This procedure is applicable to all incoming Raw materials, In-process and Finished products.
2. Apparatus
   1. pH Meter
   2. calibrated thermometer
   3. Calibrated Balance
3. Reagents
   1. Potassium chloride
4. Procedure
   1. Operate the pH meter as per the Standard Operating Procedure.
   2. Check whether pH meter is calibrated or not. If not calibrate it.
   3. All measurements should be made at the same temperature of 23°C to 25°C unless otherwise specified

                             in the monograph.

1. 4. Immerse the electrodes in the solution being examined and measure the pH at the same temperature as

                            for the buffer solutions.

1. 5. All solutions and suspensions of substances being examined and the reference buffer solutions must

                             be prepared using carbon dioxide-free water.

1. 6. When measuring pH values above 10.0, ensure that the glass electrode is suitable for use under

                                alkaline conditions and apply any correction that is necessary.

1. 7. For monographs other than those from the European Pharmacopoeia and USP, record the pH of the

                                   solution used to standardize the meter and electrodes at the end of a set of measurements. If the

                                    difference between this reading and the original value is greater than 0.05, the set of measurements

                                        must be repeated.

1. 8. Weigh accurately the substance as given in individual test procedure and transfer it into a clean

                            beaker, add specified quantity of purified water / solvent, dissolve the substance completely or

                                   Prepare the sample solution / suspension as mentioned in the test procedure.

1. 9. Wash the electrode with purified water and blot it with tissue paper.

                           Note: Determine the pH to the nearest 0.1 unit and record the reading in the worksheet.

5. Reference
   1. None
6. Revision History

Revision No.	Details of Changes	Reason for change
00	New GTP	NA

End of Document

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