The purpose of the document is to establish a method for pH measurement of Asava/Arista.
2.0 SCOPE
This standard testing procedure is suitable for the determination of pH measurement.
3.0 RESPONSIBILITY
The expert and trained Chemist are responsible for following this procedure. The technical manager is responsible for implementing this procedure.
4.0REQUIREMENTS
4.1 Apparatus
4.1.1 pH Meter
4.2 Glassware
4.2.1 Beaker (50 ml)
4.2.2 Glass rod
4.2 Reagent
4.3.1 Buffer solution (4.01, 7.0, and 10.01)
5.0 PROCEDURE
5.1 Before use, rinse the electrode with distilled water and dry it with tissue.
5.2 Calibrate the pH meter by using buffer solutions of 4.01, 7, and 10.01.
5.3 Take approximately 30 ml Asava/Arista in a 50 ml beaker (care should be taken so that electrode
dips properly in the drug but not touching the bottom and sides of the beaker).
5.4 Transfer the electrode to the test solution.
5.5 Record the pH when the reading is stable.
5.6 Rinse the electrode with distilled water, dry and store it in the Storage solution.
6.0 CALCULATION: NA
7.0 REVISION/CHANGE HISTORY: NA
8.0 ATTACHMENTS
Appendix-1: FLOW CHART FOR pH MEASUREMENT
9.0 REFERENCES
A.P.I Part II, Vol-II; First Edition-2009.
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END OF THE DOCUMENT
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