Potassium Chloride Oral Solution
» Potassium Chloride Oral Solution contains not less than 95.0 percent and not more than 105.0 percent of the labeled amount of KCl. It may contain alcohol.
Packaging and storage Preserve in tight containers.
Identification Carefully evaporate about 5 mL to dryness, and ignite the residue at dull-red heat to remove all organic matter. Cool, dissolve the residue in 10 mL of water, and filter: the filtrate responds to the tests for Potassium 191 and for Chloride 191.
Alcohol content (if present) 611: not less than 90.0% and not more than 115.0% of the labeled amount, the labeled amount being not more than 7.5% of C2H5OH, determined by the gas-liquid chromatographic procedure, acetone being used as the internal standard.
Potassium stock solution Dissolve 190.7 mg of potassium chloride, previously dried at 105 for 2 hours, in water. Transfer to a 1000-mL volumetric flask, dilute with water to volume, and mix. Transfer 100.0 mL of this solution to a 1000-mL volumetric flask, dilute with water to volume, and mix. This solution contains 10 µg of potassium (equivalent to 19.07 µg of potassium chloride) per mL.
Standard preparations To separate 100-mL volumetric flasks transfer 10.0, 15.0, and 20.0 mL, respectively, of Potassium stock solution. To each flask add 2.0 mL of sodium chloride solution (1 in 5) and 1.0 mL of hydrochloric acid, dilute with water to volume, and mix. The Standard preparations contain, respectively, 1.0, 1.5, and 2.0 µg of potassium per mL.
Assay preparation Transfer an accurately measured volume of Oral Solution, equivalent to about 600 mg of potassium chloride, to a 500-mL volumetric flask, dilute with water to volume, and mix. Transfer 5.0 mL of the solution to a 100-mL volumetric flask, dilute with water to volume, and mix. Transfer 5.0 mL of the resulting solution to a 100-mL volumetric flask, add 2.0 mL of sodium chloride solution (1 in 5) and 1.0 mL of hydrochloric acid, dilute with water to volume, and mix.
Procedure Concomitantly determine the absorbances of the Standard preparations and the Assay preparation at the potassium emission line of 766.5 nm, with a suitable atomic absorption spectrophotometer (see Spectrophotometry and Light-scattering 851) equipped with a potassium hollow-cathode lamp and an airacetylene flame, using water as the blank. Plot the absorbance of the Standard preparation versus concentration, in µg per mL, of potassium, and draw the straight line best fitting the three plotted points. From the graph so obtained, determine the concentration, in µg per mL, of potassium in the Assay preparation. Calculate the quantity, in mg, of KCl in the portion of Oral Solution taken by the formula:
200C(1.907)in which C is the concentration, in µg per mL, of potassium in the Assay preparation, and 1.907 is the ratio of the molecular weight of potassium chloride to the atomic weight of potassium.