Potassium Chloride in Dextrose and Sodium Chloride Injection
»Potassium Chloride in Dextrose and Sodium Chloride Injection is a sterile solution of Potassium Chloride,Dextrose,and Sodium Chloride in Water for Injection.It contains not less than 95.0percent and not more than 110.0percent of the labeled amounts of potassium (K)and chloride (Cl)and not less than 95.0percent and not more than 105.0percent of the labeled amounts of dextrose (C6H12O6·H2O)and sodium (Na).It contains no antimicrobial agents.
Packaging and storage— Preserve in single-dose containers,preferably of Type Ior Type IIglass,or of a suitable plastic.
Labeling— The label states the potassium,sodium,and chloride contents in terms of milliequivalents in a given volume.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—
A: It responds to the flame test for Sodium á191ñ.
B: To 2mLof Injection add 5mLof sodium cobaltinitrite TS:a yellow precipitate is formed immediately.If necessary,centrifuge the solution and examine the precipitate (presence of potassium).
C: It responds to the tests for Chloride á191ñ.
D: It responds to the Identificationtest under Dextrose.
Bacterial endotoxins á85ñ— It contains not more than 0.5USP Endotoxin Unit per mL.
pHá791ñ: between 3.5and 6.5.
Heavy metals á231ñ— Transfer to a suitable vessel a volume,in mL,of Injection,calculated to two significant figures by the formula:
0.2/[(GKLK)+(GDLD)+(GSLS)],
in which GK,GD,and GSare the labeled amounts,in g,of potassium chloride,dextrose,and sodium chloride,respectively,in each 100mLof Injection,and LK,LD,and LSare the limits,in percentage,for Heavy metalsspecified under Potassium Chloride,Dextrose,and Sodium Chloride,respectively.Adjust the volume by evaporation or addition of water to 25mL,as necessary:it passes the test.
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 under Injections á1ñ.
Assay for potassium and sodium—
Internal standard solution,Potassium stock solution,Sodium stock solution,Stock standard preparation,and Standard preparation— Prepare as directed in the Assay for potassium and sodiumunder Potassium Chloride in Sodium Chloride Injection.
Assay preparation— Transfer 5.0mLof Potassium Chloride in Dextrose and Sodium Chloride Injection to a 500-mLvolumetric flask,dilute with Internal standard solutionto volume,and mix.
Procedure— Proceed as directed for Procedurein the Assay for potassium and sodiumunder Potassium Chloride in Sodium Chloride Injection.
Assay for chloride— Transfer an accurately measured volume of Injection,equivalent to about 55mg of chloride,to a conical flask,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 3.545mg of Cl.Each mg of chloride is equivalent to 0.0282mEq of Cl.
Assay for dextrose— Transfer an accurately measured volume of Injection,containing between 2g and 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.
Auxiliary Information— Staff Liaison:Karen A Russo,Ph.D.,Scientist
Expert Committee:(PA1)Pharmaceutical Analysis 1
USP28–NF23Page 1587
Pharmacopeial Forum:Volume No.30(5)Page 1641
Phone Number:1-301-816-8379