Potassium Bicarbonate and Potassium Chloride for Effervescent Oral Solution

» Potassium Bicarbonate and Potassium Chloride for Effervescent Oral Solution contains not less than 90.0 percent and not more than 110.0 percent of the labeled amounts of K and 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— A 3-g portion dissolves in 100 mL of water with effervescence. The collected gas so obtained responds to the test for Bicarbonate

191

, and the resulting solution responds to the tests for Potassium

191

and for Chloride

191

Minimum fill

755

—

For Solid Packaged in Multiple-unit Containers: meets the requirements.

Uniformity of dosage units

905

—

For Solid Packaged in Single-unit Containers: meets the requirements.

Assay for potassium—

Potassium stock solution and Standard preparations— Prepare as directed in the Assay under Potassium Chloride Oral Solution.

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

400C

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

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

Auxiliary Information— Please check for your question in the FAQs before contacting USP.

Topic/Question	Contact	Expert Committee
Monograph	Daniel K. Bempong, Ph.D. Senior Scientist 1-301-816-8143	(MDPS05) Monograph Development-Pulmonary and Steroids

USP32–NF27 Page 3332