Dissolution 711
Medium:
water; 900 mL.
Apparatus 2:
100 rpm.
Time:
45 minutes.
Procedure
Determine the amount of C
6H
11KO
7 dissolved, employing the procedure set forth in the
Assay, making any necessary modifications.
Tolerances
Not less than 75% (Q) of the labeled amount of C6H11KO7 is dissolved in 45 minutes.
Assay
Assay preparation
Weigh and finely powder not less than 20 Tablets. Transfer an accurately weighed portion of the powder, equivalent to about 1.8 g of potassium gluconate, to a 1000-mL volumetric flask, add water to volume, and mix to dissolve. Filter a portion of the solution, transfer 10.0 mL of the filtrate 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 C
6H
11KO
7 in the portion of Tablets taken by the formula:
200C(234.25 / 39.10),
in which 234.25 is the molecular weight of potassium gluconate and 39.10 is the atomic weight of potassium.