Potassium Chloride in Lactated Ringer's and Dextrose Injection
»Potassium Chloride in Lactated Ringer's and Dextrose Injection is a sterile solution of Calcium Chloride,Potassium Chloride,Sodium Chloride,and Sodium Lactate in Water for Injection.It contains,in each 100mL,not less than 285.0mg and not more than 315.0mg of sodium (as NaCl and C3H5NaO3),not less than 4.90mg and not more than 6.00mg of calcium (Ca,equivalent to not less than 18.0mg and not more than 22.0mg of CaCl2·2H2O),and not less than 231.0mg and not more than 261.0mg of lactate (C3H5O3,equivalent to not less than 290.0mg and not more than 330.0mg of C3H5NaO3).It contains not less than 95.0percent and not more than 105.0percent of the labeled amount of Potassium Chloride (KCl),not less than 90.0percent and not more than 105.0percent of the labeled amount of dextrose (C6H12O6·H2O),and not less than 90.0percent and not more than 110.0percent of the labeled amount of chloride (Cl,as NaCl,KCl,and CaCl2·2H2O).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,the label alternatively may state the total osmolar concentration in mOsmol per mL.The label includes also the warning:“Not for use in the treatment of lactic acidosis.”
Identification—
A: It responds to the Identificationtest under Dextrose Injection.
B: It responds to the flame tests for Sodium á191ñand for Potassium á191ñ,to the test for Chloride á191ñ,and to the ammonium oxalate test for Calcium á191ñ.
C: The retention time of the lactate peak in the chromatogram of the Assay preparationcorresponds to that of the Standard preparationas obtained in the Assay for lactate.
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/[(GSLS)+(GKLK)+(GCLC)+(GLLL)+(GDLD)],
in which GS,GK,GC,GL,and GDare the labeled amounts,in g,of sodium chloride,potassium chloride,calcium chloride,sodium lactate,and dextrose,respectively,in each 100mLof Injection,and LS,LK,LC,LL,and LDare the limits,in percentage,for Heavy metalsspecified under Sodium Chloride,Potassium Chloride,Calcium Chloride,Sodium Lactate,and Dextrose,respectively.Adjust the volume by evaporation or addition of water to 25mL,as necessary:it meets the requirements of the test.
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 under Injections á1ñ.
Assay for calcium— [NOTE—Concentrations of the Standard preparations and the Assay preparation may be modified to fit the linear or working range of the atomic absorption spectrophotometer.]
Lanthanum chloride solutionand Blank solution— Prepare as directed in the Assay for calciumunder Ringer's Injection.
Calcium stock solutionand Standard preparations— Prepare as directed in the Assay for calciumunder Ringer's Injection.
Assay preparation— Transfer 30.0mLof Injection (equivalent to about 1.6mg of calcium),to a 100-mLvolumetric flask containing 5.0mLof Lanthanum chloride solution.Dilute the contents of the flask with water to volume,and mix.
Procedure— Proceed as directed in the Assay for calciumunder Ringer's Injection.Calculate the quantity,in mg,of calcium in each 100mLof the Injection taken by the formula:
C/3,
in which Cis the concentration,in µg per mL,of calcium in the Assay preparation,as determined from the graph.
Assay for potassium— Proceed with Injection as directed in the Assay for potassiumunder Ringer's Injection.
Assay for sodium— Proceed with Injection as directed in the Assay for sodiumunder Ringer's Injection.
Assay for chloride— Proceed with Injection as directed in the Assay for chlorideunder Ringer's Injection.
Assay for lactate—
Mobile phase,Resolution solution,Standard preparation,Chromatographic system,and Procedure— Proceed as directed in the Assay for lactateunder Lactated Ringer's Injection.
Assay preparation— Use undiluted Injection.
Procedure— Proceed as directed in the Assay for lactateunder Lactated Ringer's Injection.Calculate the concentration,in mg per mL,of lactate (C3H5O3)in the Assay preparationtaken by the formula:
C(89.07/112.06)(rU/rS),
in which the terms are as defined therein.
Assay for dextrose— Proceed with Injection as directed in the Assay for dextroseunder Ringer's and Dextrose Injection.
Auxiliary Information— Staff Liaison:Karen A Russo,Ph.D.,Scientist
Expert Committee:(PA1)Pharmaceutical Analysis 1
USP28–NF23Page 1588
Phone Number:1-301-816-8379