U.S. PHARMACOPEIA

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Potassium Chloride for Oral Solution
» Potassium Chloride for Oral Solution is a dry mixture of Potassium Chloride and one or more suitable colors, diluents, and flavors. It contains not less than 90.0 percent and not more than 110.0 percent of the labeled amount of KCl.
Packaging and storage— Preserve in tight containers.
Labeling— The label states the Potassium Chloride (KCl) content in terms of weight and in terms of milliequivalents.
Identification— Ignite about 200 mg at a temperature not above 600, in order to remove all organic matter, cool, dissolve the residue in 10 mL of water, and filter: the filtrate 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.
Residual solvents 467: meets the requirements.
(Official January 1, 2007)
Assay—
Potassium stock solution and Standard preparations— Prepare as directed in the Assay under Potassium Chloride Oral Solution.
Assay preparation 1 (where it is packaged in unit-dose containers)—Weigh and mix the contents of not less than 20 containers of Potassium Chloride for Oral Solution. Transfer an accurately weighed portion of the powder, equivalent to about 1.5 g of potassium chloride, to a 500-mL volumetric flask, dissolve in water, dilute with water to volume, and mix. Transfer 5.0 mL of the solution to a 250-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.
Assay preparation 2 (where it is packaged in multiple-unit containers)—Transfer an accurately weighed portion of Potassium Chloride for Oral Solution, equivalent to about 1.5 g of potassium chloride, to a 500-mL volumetric flask, dissolve in water, dilute with water to volume, and mix. Proceed as directed for Assay preparation 1, beginning with “Transfer 5.0 mL of the solution.”
Procedure— Proceed as directed for Procedure in the Assay under Potassium Chloride Oral Solution. Calculate the quantity of KCl, in mg, in the portion of Potassium Chloride for Oral Solution taken by the formula:
500C(1.907),
in which C is as defined therein.
Auxiliary Information— Staff Liaison : Daniel K. Bempong, Ph.D., Scientist
Expert Committee : (MDPS05) Monograph Development-Pulmonary and Steroids
USP29–NF24 Page 1762
Phone Number : 1-301-816-8143