Potassium Bicarbonate and Potassium Chloride for Effervescent Oral Solution, chemical structure, molecular formula, Reference Standards

Potassium Bicarbonate and Potassium Chloride for Effervescent Oral Solution

»Potassium Bicarbonate and Potassium Chloride for Effervescent Oral Solution contains not less than 90.0percent and not more than 110.0percent of the labeled amounts of Kand Cl.

Packaging and storage— Preserve in tight containers,protected from excessive heat.

Labeling— The label states the potassium and chloride contents in terms of weight and in terms of milliequivalents.Where packaged in individual pouches,the label instructs the user not to open until the time of use.

Identification— A3-g portion dissolves in 100mLof water with effervescence.The collected gas so obtained responds to the test for Bicarbonate á191ñ,and the resulting solution responds to the tests for Potassium á191ñand for Chloride á191ñ.

Minimum fill á755ñ—

FORSOLIDPACKAGEDINMULTIPLE-UNITCONTAINERS: meets the requirements.

Uniformity of dosage units á905ñ—

FORSOLIDPACKAGEDINSINGLE-UNITCONTAINERS: meets the requirements.

Assay for potassium—

Potassium stock solutionand Standard preparations— Prepare as directed in the Assayunder Potassium Chloride Oral Solution.

Assay preparation— Weigh and mix the contents of not less than 20containers of Potassium Bicarbonate and Potassium Chloride for Effervescent Oral Solution.Transfer an accurately weighed portion of the powder,equivalent to about 6g of potassium,to a 1000-mLvolumetric flask,dissolve in about 200mLof water,dilute with water to volume,and mix.Transfer 5.0mLof this solution to a second 1000-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 Chloride Oral Solution.Calculate the quantity,in mg,of Kin the portion of Potassium Bicarbonate and Potassium Chloride for Effervescent Oral Solution taken by the formula:

400C,

in which Cis the concentration,in µg per mL,of potassium in the Assay preparation.

Assay for chloride— Weigh and mix the contents of not less than 20containers of Potassium Bicarbonate and Potassium Chloride for Effervescent Oral Solution.Transfer a portion of the powder,equivalent to about 900mg of chloride,to a 2000-mLvolumetric flask.Add about 200mLof water,swirl until effervescence ceases,dilute with water to volume,and mix.Transfer 25.0mLof this solution to a 250-mLconical flask,add 50.0mLof 0.1Nsilver nitrate VSand 15mLof nitric acid,and boil,with constant swirling,until the solution is colorless.Cool to room temperature,add water to make about 150mL,then add 5mLof ferric ammonium sulfate TS,and titrate the excess silver nitrate with 0.1Nammonium thiocyanate VSto a permanent faint brown endpoint.Each mLof 0.1Nsilver nitrate is equivalent to 3.545mg of Cl.

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