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 C
6H
11KO
7dissolved,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.
Assay
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 C
6H
11KO
7in 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.