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Potassium Gluconate, Potassium Citrate, and Ammonium Chloride Oral Solution
» Potassium Gluconate, Potassium Citrate, and Ammonium Chloride Oral Solution is a solution of Potassium Gluconate, Potassium Citrate, and Ammonium Chloride in a suitable aqueous medium. It contains not less than 90.0 percent and not more than 110.0 percent of the labeled amounts of potassium (K) and chloride (Cl).
Packaging and storage
Preserve in tight containers.
Labeling
Label it to state the potassium and chloride contents in terms of milliequivalents of each in a given volume of Oral Solution.
Identification
A:
To 2 mL of a dilution of Oral Solution (1 in 40) add 5 mL of sodium cobaltinitrite TS: a yellow precipitate is formed immediately (presence of potassium).
B:
It responds to the test for Citrate
Assay for potassium
Potassium stock solution
Dissolve in water 0.9535 g of potassium chloride, previously dried at 105
Standard preparations
To separate 200-mL volumetric flasks transfer 19.0 mL and 25.0 mL, respectively, of the Potassium stock solution, dilute with water to volume, and mix. The Standard preparations contain 95.0 µg and 125.0 µg of potassium per mL, respectively.
Assay preparation
Transfer an accurately measured volume of Oral Solution, equivalent to about 782 mg (20 mEq) of potassium, to a 100-mL volumetric flask, dilute with water to volume, and mix. Transfer 7.0 mL of this solution to a 500-mL volumetric flask, dilute with water to volume, and mix.
Procedure
Concomitantly determine the absorbances of the Standard preparations and the Assay preparation at the resonance line of 766.5 nm, with a suitable atomic absorption spectrophotometer (see Spectrophotometry and Light-scattering
(50 / 7)(C / V)
in which V is the volume, in mL, of Oral Solution taken. Each mg of potassium is equivalent to 0.02558 mEq.
Assay for chloride
Ionic strength adjusting solution
Use 5 M sodium nitrate.
Procedure
Transfer an accurately measured volume of Oral Solution, equivalent to about 100 mg (2.8 mEq) of chloride, to a suitable beaker. Add 2.0 mL of Ionic strength adjusting solution and water to make about 100 mL, and titrate with 0.1 N silver nitrate VS, determining the endpoint potentiometrically, using a silver-sulfide specific ion-selective electrode and a double-junction reference electrode containing potassium nitrate solution (1 in 10). Perform a blank determination, and make any necessary correction. Each mL of 0.1 N silver nitrate is equivalent to 3.545 mg of chloride (Cl). Each mg of chloride is equivalent to 0.0282 mEq of Cl.
Auxiliary Information
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USP32NF27 Page 3348
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