Potassium Gluconate Elixir
(Current title—not to change until June 1,2005)
Monograph title change—to become official June 1,2005
See Potassium Gluconate Oral Solution
»Potassium Gluconate Elixir contains not less than 95.0percent and not more than 105.0percent of the labeled amount of C6H11KO7.
Packaging and storage— Preserve in tight,light-resistant containers.
Identification—
A: It responds to 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 Elixir,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 C6H11KO7in each mLof the Elixir taken by the formula:
(200C/V)(234.25/39.10),
in which Vis the volume of Elixir taken;234.25is the molecular weight of potassium gluconate;and 39.10is the atomic weight of potassium.
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
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