Potassium Bicarbonate Effervescent Tablets for Oral Solution
» Potassium Bicarbonate Effervescent Tablets for Oral Solution contain not less than 90.0 percent and not more than 110.0 percent of the labeled amount of K.
Packaging and storage— Preserve in tight containers, protected from excessive heat.
Labeling— The label states the potassium content in terms of weight and in terms of milliequivalents. Where the Tablets are packaged in individual pouches, the label instructs the user not to open until the time of use.
Identification— One Tablet dissolves in 100 mL of water with effervescence. The collected gas responds to the test for Bicarbonate 191, and the resulting solution responds to the test for Potassium 191.
Uniformity of dosage units 905: meet the requirements.
Assay—
Potassium stock solution and Standard preparations— Prepare as directed in the Assay under Potassium Chloride Oral Solution.
Assay preparation— Transfer 10 Tablets to a 2000-mL volumetric flask, dissolve in 200 mL of water, swirl until effervescence ceases, dilute with water to volume, and mix. Filter, and quantitatively dilute an accurately measured volume of the filtrate with water to obtain a solution containing 30 µg of potassium per mL. 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 Chloride Oral Solution. Calculate the quantity, in mg, of K in each Tablet taken by the formula:
L(C / D)
in which L is the labeled quantity, in mg, of potassium in each Tablet, C is the concentration, in µg per mL, of potassium in the Assay preparation, and D is the concentration, in µg per mL, of potassium in the Assay preparation on the basis of the labeled quantity in each Tablet and the extent of dilution.
Auxiliary Information— Please check for your question in the FAQs before contacting USP.
Topic/Question Contact Expert Committee
Monograph Mary S. Waddell
Scientific Liaison
1-301-816-8124		 (SM42010) Monographs - Small Molecules 4
USP35–NF30 Page 4355