Potassium Gluconate Tablets
»Potassium Gluconate Tablets contain not less than 95.0percent and not more than 105.0percent of the labeled amount of C6H11KO7.
Packaging and storage— Preserve in tight containers.
Identification—
A: The IRabsorption spectrum of a mineral oil dispersion prepared from finely powdered Tablets exhibits maxima only at the same wavelengths as that of a similar preparation of USP Potassium Gluconate RS.
B: Triturate a portion of powdered Tablets with a few mLof water,and filter:the filtrate responds to the flame test for Potassium á191ñ.
Dissolution á711ñ
Medium: water;900mL.
Apparatus 2: 100rpm.
Time: 45minutes.
Procedure— Determine the amount of C6H11KO7dissolved,employing the procedure set forth in the Assay,making any necessary modifications.
Tolerances— Not less than 75%(Q)of the labeled amount of C6H11KO7is dissolved in 45minutes.
Uniformity of dosage units á905ñ: meet the requirements.
Assay—
Potassium stock solutionand Standard preparations Prepare as directed in the Assayunder Potassium Gluconate.
Assay preparation— Weigh and finely powder not less than 20Tablets.Transfer an accurately weighed portion of the powder,equivalent to about 1.8g of potassium gluconate,to a 1000-mLvolumetric flask,add water to volume,and mix to dissolve.Filter a portion of the solution,transfer 10.0mLof the filtrate 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 the portion of Tablets taken by the formula:
200C(234.25/39.10),
in which 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
Phone Number:1-301-816-8389