Potassium Bicarbonate Effervescent Tablets for Oral Solution
»Potassium Bicarbonate Effervescent Tablets for Oral Solution contain not less than 90.0percent and not more than 110.0percent 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 100mLof water with effervescence.The collected gas responds to the test for Bicarbonate á191ñ,and the resulting solution responds to the test for Potassium á191ñ.
Uniformity of dosage units á905ñ: meet the requirements.
Assay—
Potassium stock solutionand Standard preparations— Prepare as directed in the Assayunder Potassium Chloride Oral Solution.
Assay preparation— Transfer 10Tablets to a 2000-mLvolumetric flask,dissolve in 200mLof 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 30µg of potassium per mL.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 Chloride Oral Solution.Calculate the quantity,in mg,of Kin each Tablet taken by the formula:
L(C/D),
in which Lis the labeled quantity,in mg,of potassium in each Tablet,Cis the concentration,in µg per mL,of potassium in the Assay preparation,and Dis the concentration,in µg per mL,of potassium in the Assay preparationon the basis of the labeled quantity in each Tablet and the extent of dilution.
Auxiliary Information— Staff Liaison:Karen A Russo,Ph.D.,Scientist
Expert Committee:(PA1)Pharmaceutical Analysis 1
USP28–NF23Page 1581
Phone Number:1-301-816-8379