Potassium Gluconate Tablets
» Potassium Gluconate Tablets contain not less than 95.0 percent and not more than 105.0 percent of the labeled amount of C6H11KO7.
Packaging and storage Preserve in tight containers.
A: The IR absorption 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 mL of water, and filter: the filtrate responds to the flame test for Potassium 191.
Medium: water; 900 mL.
Apparatus 2: 100 rpm.
Time: 45 minutes.
Procedure Determine the amount of C6H11KO7 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.
Uniformity of dosage units 905: meet the requirements.
Potassium stock solution and Standard preparations Prepare as directed in the Assay under Potassium Gluconate.
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 C6H11KO7 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.
Auxiliary Information Please check for your question in the FAQs before contacting USP.
USP32NF27 Page 3346