Potassium Chloride for Injection Concentrate
»Potassium Chloride for Injection Concentrate is a sterile solution of Potassium Chloride in Water for Injection.It contains not less than 95.0percent and not more than 105.0percent of the labeled amount of KCl.
Packaging and storage— Preserve in single-dose or in multiple-dose containers,preferably of Type Ior Type IIglass.
Labeling— The label states the potassium chloride content in terms of weight and of milliequivalents in a given volume.Label the Concentrate to indicate that it is to be diluted to appropriate strength with water or other suitable fluid prior to administration.Immediately following the name,the label bears the boxed warning:
ConcentrateMust be DilutedBefore Use
This warning is not required when the liquid preparation is in a Pharmacy bulk packageand the label thereon states prominently “Pharmacy Bulk Package—Not for direct infusion.”
The cap of the container and the overseal of the cap must be black,and both bear the words:“Must Be Diluted”in readily legible type,in a color that stands out from its background ORthe overseal may be of a clear plastic material through which the black cap is visible and the printing is readily legible.
When the nature of the container-closure system prevents compliance,the design shall follow the intent of this requirement as closely as possible,the black color being used beneath the words “Must be Diluted,”which are so placed that words are readily visible as the contents of the container are being removed.Ampuls shall be identified by a black band or a series of black bands above the constriction.The label states also the total osmolar concentration in mOsmol per liter.Where the contents are less than 100mL,the label alternatively may state the total osmolar concentration in mOsmol per mL.
Identification— It responds to the tests for Potassium á191ñand for Chloride á191ñ.
Bacterial endotoxins á85ñ: It contains not more than 8.80USP Endotoxin Units per mEq.
pHá791ñ: between 4.0and 8.0.
Particulate matter á788ñ: meets the requirements under small-volume injections.
Other requirements— It meets the requirements under Injections á1ñ.
Assay—
Potassium stock solutionand Standard preparations— Prepare as directed in the Assayunder Potassium Chloride Oral Solution.
Assay preparation— Transfer an accurately measured volume of Concentrate,equivalent to about 600mg of potassium chloride,to a 500-mLvolumetric flask,dilute with water to volume,and mix.Proceed as directed for Assay preparationin the Assayunder Potassium Chloride Oral Solution,beginning with “Transfer 5.0mLof the solution to a 100-mLvolumetric flask.”
Procedure— Proceed as directed for Procedurein the Assayunder Potassium Chloride Oral Solution.Calculate the quantity,in mg,of KCl in the portion of Concentrate taken by the formula:
200C(1.907),
in which the terms are 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
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