Potassium Gluconate Oral Solution
(Monograph under this new title—to become official June 1,2005)
(Current monograph title is Potassium Gluconate Elixir)
»Potassium Gluconate Oral Solution contains not less than 95.0percent and not more than 105.0percent of the labeled amount of potassium gluconate (C6H11KO7).
Packaging and storage— Preserve in tight,light-resistant containers.
Identification—
A: It meets the requirements of the flame test for Potassium á191ñ.
B: Evaporate 5mLon a steam bath to dryness:a mineral oil dispersion of the residue exhibits an IRabsorption maximum in the spectral region between 6.2and 6.25µm (carboxylic acid salt).
Alcohol content,Method IIá611ñ: between 4.5%and 5.5%of C2H5OH.
Assay—
Potassium stock solution andStandard preparations— Prepare as directed in the Assayunder Potassium Gluconate.
Assay preparation— Transfer an accurately measured volume of Oral Solution,equivalent to about 1.8g of potassium gluconate,to a 1000-mLvolumetric flask,dilute with water to volume,and mix.Transfer 10.0mLof the solution to a 100-mLvolumetric flask,dilute with water to volume,and mix.Transfer 5.0mLof the resulting solution to a 100-mLvolumetric flask,add 2.0mLof sodium chloride solution (1in 5)and 1.0mLof hydrochloric acid,dilute with water to volume,and mix.
Procedure— Proceed as directed for Procedurein the Assayunder Potassium Gluconate.Calculate the quantity,in mg,of potassium gluconate (C6H11KO7)in each mLof the Oral Solution taken by the formula:
(200C/V)(234.25/39.10),
in which Vis the volume of Oral Solution taken;234.25is the molecular weight of potassium gluconate;and 39.10is the atomic weight of potassium.
(Official June 1,2005)
Auxiliary Information— Staff Liaison:Lawrence Evans,III,Ph.D.,Scientist
Expert Committee:(DSN)Dietary Supplements:Non-Botanicals
USP28–NF23Page 1592
Pharmacopeial Forum:Volume No.28(2)Page 345
Phone Number:1-301-816-8389