Potassium Gluconate Oral Solution
» Potassium Gluconate Oral Solution contains not less than 95.0 percent and not more than 105.0 percent of the labeled amount of potassium gluconate (C6H11KO7).
Packaging and storage Preserve in tight, light-resistant containers.
A: It meets the requirements of the flame test for Potassium 191.
B: Evaporate 5 mL on a steam bath to dryness: a mineral oil dispersion of the residue exhibits an IR absorption maximum in the spectral region between 6.2 and 6.25 µm (carboxylic acid salt).
Alcohol content, Method II 611: between 4.5% and 5.5% of C2H5OH.
Potassium stock solution and Standard preparations Prepare as directed in the Assay under Potassium Gluconate.
Assay preparation Transfer an accurately measured volume of Oral Solution, equivalent to about 1.8 g of potassium gluconate, to a 1000-mL volumetric flask, dilute with water to volume, and mix. Transfer 10.0 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 Proceed as directed for Procedure in the Assay under Potassium Gluconate. Calculate the quantity, in mg, of potassium gluconate (C6H11KO7) in each mL of the Oral Solution taken by the formula:
(200C / V)(234.25 / 39.10)in which V is the volume of Oral Solution taken; 234.25 is the molecular weight of potassium gluconate; and 39.10 is the atomic weight of potassium.