Potassium Chloride in Dextrose Injection
»Potassium Chloride in Dextrose Injection is a sterile solution of Potassium Chloride and Dextrose in Water for Injection.It contains not less than 95.0percent and not more than 110.0percent of the labeled amount of KCl and not less than 95.0percent and not more than 105.0percent of the labeled amount of C6H12O6·H2O.It contains no antimicrobial agents.
Packaging and storage— Preserve in single-dose glass or plastic containers.Glass containers are preferably of Type Ior Type IIglass.
Labeling— The label states the total osmolar concentration in mOsmol per liter.Where the contents are less than 100mL,or where the label states that the Injection is not for direct injection but is to be diluted before use,the label alternatively may state the total osmolar concentration in mOsmol per mL.The content of potassium,in milliequivalents,is prominently displayed on the label.
Identification— It responds to the Identificationtest under Dextrose,to the flame test for Potassium á191ñ,and to the tests for Chloride á191ñ.
Bacterial endotoxins á85ñ— It contains not more than 0.5USP Endotoxin Unit per mL.
pHá791ñ: between 3.5and 6.5,determined on a portion diluted with water,if necessary,to a concentration of not more than 5%of dextrose.
Limit of 5-hydroxymethylfurfural and related substances— Dilute an accurately measured volume of Injection,equivalent to 1.0g of C6H12O6·H2O,with water to 500.0mL.Determine the absorbance of this solution in a 1-cm cell at 284nm,with a suitable spectrophotometer,using water as the blank:the absorbance is not more than 0.25.
Other requirements— It meets the requirements of the test for Heavy metalsunder Dextrose Injection,and meets the requirements under Injections á1ñ.
Assay for dextrose— Transfer an accurately measured volume of Injection,containing between 2and 5g of dextrose,to a 100-mLvolumetric flask.Add 0.2mLof 6Nammonium hydroxide,dilute with water to volume,and mix.Determine the angular rotation in a suitable polarimeter tube at 25(see Optical Rotation á781ñ).The observed rotation,in degrees,multiplied by 1.0425A,in which Ais the ratio 200divided by the length,in mm,of the polarimeter tube employed,represents the weight,in g,of C6H12O6·H2Oin the volume of Injection taken.
Assay for potassium chloride— Transfer an accurately measured volume of Injection,equivalent to between 75and 150mg of potassium chloride,to a conical flask,add water,if necessary,to bring the volume to about 10mL,and add 10mLof glacial acetic acid,75mLof methanol,and 3drops of eosin Y TS.Titrate,with shaking,with 0.1Nsilver nitrate VSto a pink endpoint.Each mLof 0.1Nsilver nitrate is equivalent to 7.455mg of KCl.
Auxiliary Information— Staff Liaison:Karen A Russo,Ph.D.,Scientist
Expert Committee:(PA1)Pharmaceutical Analysis 1
USP28–NF23Page 1586
Pharmacopeial Forum:Volume No.30(5)Page 1640
Phone Number:1-301-816-8379