Ringer's and Dextrose Injection
»Ringer's and Dextrose Injection is a sterile solution of Sodium Chloride,Potassium Chloride,Calcium Chloride,and Dextrose in Water for Injection.It contains,in each 100mL,not less than 323.0mg and not more than 354.0mg of sodium (Na,equivalent to not less than 820.0mg and not more than 900.0mg of NaCl),not less than 14.9mg and not more than 16.5mg of potassium (K,equivalent to not less than 28.5mg and not more than 31.5mg of KCl),not less than 8.20mg and not more than 9.80mg of calcium (Ca,equivalent to not less than 30.0mg and not more than 36.0mg of CaCl2·2H2O),and not less than 523.0mg and not more than 608.5mg of chloride (Cl,as NaCl,KCl,and CaCl2·2H2O).It contains not less than 95.0percent and not more than 105.0percent of the labeled amount of dextrose (C6H12O6·H2O).It contains no antimicrobial agents.
NOTE—The calcium,chloride,potassium,and sodium ion contents of Ringer's and Dextrose Injection are approximately 4.5,156,4,and 147.5milliequivalents per liter,respectively.
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.
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.
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)+(GDLD)],
in which GS,GK,GC,and GDare the labeled amounts,in g,of sodium chloride,potassium chloride,calcium chloride,and dextrose,respectively,in each 100mLof Injection,and LS,LK,LC,and LDare the limits,in percentage,for Heavy metalsspecified under Sodium Chloride,Potassium Chloride,Calcium Chloride,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 solution,Blank solution,Calcium stock solution,andStandard preparations— Prepare as directed in the Assay for calciumunder Ringer's Injection.
Assay preparation— Transfer 20.0mLof Injection (equivalent to about 1.8mg 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:
0.5C,
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 dextrose— Transfer an accurately measured volume of Injection,containing 2to 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 1736
Pharmacopeial Forum:Volume No.30(5)Page 1647
Phone Number:1-301-816-8379