Potassium Gluconate and Potassium Chloride Oral Solution, chemical structure, molecular formula, Reference Standards

Potassium Gluconate and Potassium Chloride Oral Solution

»Potassium Gluconate and Potassium Chloride Oral Solution is a solution of Potassium Gluconate and Potassium Chloride in a suitable aqueous medium.It contains not less than 90.0percent and not more than 110.0percent 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 2mLof a dilution of Oral Solution (1in 40)add 5mLof sodium cobaltinitrite TS:a yellow precipitate is formed immediately (presence of potassium).

B: Evaporate 5mLon a steam bath to dryness:a mineral oil dispersion of the residue so obtained exhibits an IRabsorption maximum in the spectral region between 6.2and 6.25µm (carboxylic acid salt).

C: It responds to the tests for Chloride á191ñ.

Assay for potassium—

Potassium stock solution— Dissolve in water 0.9535g of potassium chloride,previously dried at 105

for 2hours.Transfer to a 500-mLvolumetric flask,dilute with water to volume,and mix.This solution contains 1000µg of potassium per mL.

Standard preparations— To separate 200-mLvolumetric flasks transfer 19.0mLand 25.0mL,respectively,of Potassium stock solution,dilute with water to volume,and mix.The Standard preparationscontain 95.0µg and 125.0µg of potassium per mL,respectively.

Assay preparation— Transfer an accurately measured volume of Oral Solution,equivalent to about 782mg (20mEq)of potassium,to a 100-mLvolumetric flask,dilute with water to volume,and mix.Transfer 7.0mLof the resulting solution to a 500-mLvolumetric flask,dilute with water to volume,and mix.

Procedure— Concomitantly determine the absorbances of the Standard preparationsand the Assay preparationat the resonance line of 766.5nm,with a suitable atomic absorption spectrophotometer (see Spectrophotometry and Light-scattering á851ñ)equipped with a potassium hollow-cathode lamp and an air–acetylene flame,using water as the blank.Plot the absorbances of the Standard preparationsversus concentration,in µg per mL,of potassium.From the graph so obtained,determine the concentration,C,in µg per mL,of potassium in the Assay preparation.Calculate the quantity,in mg,of potassium in each mLof the Oral Solution taken by the formula:

(50/7)(C/V),

in which Vis the volume,in mL,of Oral Solution taken.Each mg of potassium is equivalent to 0.02558mEq.

Assay for chloride—

Ionic strength adjusting solution— Use 5Msodium nitrate.

Procedure— Transfer an accurately measured volume of Oral Solution,equivalent to about 100mg (2.8mEq)of chloride,to a suitable beaker.Add 2.0mLof Ionic strength adjusting solutionand water to make about 100mL,and titrate with 0.1Nsilver nitrate VS,determining the endpoint potentiometrically,using a silver-sulfide specific ion-selective electrode and a double-junction reference electrode containing potassium nitrate solution (1in 10).Perform a blank determination,and make any necessary correction.Each mLof 0.1Nsilver nitrate is equivalent to 3.545mg of chloride (Cl).Each mg of chloride is equivalent to 0.0282mEq of Cl.

Auxiliary Information— Staff Liaison:Karen A Russo,Ph.D.,Scientist

Expert Committee:(PA1)Pharmaceutical Analysis 1

USP28–NF23Page 1593

Phone Number:1-301-816-8379