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 90.0percent and not more than 110.0percent 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 200mg at a temperature not above 600,in order to remove all organic matter,cool,dissolve the residue in 10mLof water,and filter:the filtrate 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—
Potassium stock solutionand Standard preparations— Prepare as directed in the Assayunder Potassium Chloride Oral Solution.
Assay preparation 1 (where it is packaged in unit-dose containers)—Weigh and mix the contents of not less than 20containers of Potassium Chloride for Oral Solution.Transfer an accurately weighed portion of the powder,equivalent to about 1.5g of potassium chloride,to a 500-mLvolumetric flask,dissolve in water,dilute with water to volume,and mix.Transfer 5.0mLof the solution to a 250-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.
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 1.5g of potassium chloride,to a 500-mLvolumetric flask,dissolve in water,dilute with water to volume,and mix.Proceed as directed for Assay preparation 1,beginning with “Transfer 5.0mLof the solution.”
Procedure— Proceed as directed for Procedurein the Assayunder 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 Cis as defined therein.
Auxiliary Information— Staff Liaison:Karen A Russo,Ph.D.,Scientist
Expert Committee:(PA1)Pharmaceutical Analysis 1
USP28–NF23Page 1585
Phone Number:1-301-816-8379