Potassium Citrate Oral Solution
DEFINITION
Potassium Citrate Mixture is an oral solution containing 30% w/v of Potassium Citrate and 5% w/v of Citric Acid Monohydrate in a suitable vehicle with a lemon flavour. It is intended to be diluted with water before use.
The mixture complies with the requirements stated under Oral Liquids and with the following requirements.
Content of citric acid monohydrate, C6H8O7, H2O
4.75 to 5.25% w/v.
Content of potassium citrate, C6H5K3O7,H2O
28.5 to 31.5% w/v.
IDENTIFICATION
A. Yields reaction A characteristic of potassium salts, Appendix VI.
B. Yields reaction B characteristic of citrates, Appendix VI.
ASSAY
For citric acid monohydrate
To 5 mL add 100 mL of water, boil, cool and titrate with carbonate-free 0.1M sodium hydroxide VS using thymol blue solution as indicator. Each mL of carbonate-free 0.1M sodium hydroxide VS is equivalent to 7.005 mg of C6H8O7, H2O.
For potassium citrate
To 1 g add 5 mL of acetic anhydride and 20 mL of anhydrous acetic acid, heat on a water bath for 20 minutes, allow to cool and carry out Method I for non-aqueous titration, Appendix VIII A, using 1-naphtholbenzein solution as indicator. Each mL of 0.1M perchloric acid VS is equivalent to 10.81 mg of C6H5K3O7,H2O. Determine the weight per mL of the mixture, Appendix V G, and calculate the content of C6H5K3O7,H2O, weight in volume.
