Modified Lactated Ringer's and Dextrose Injection
»Modified Lactated Ringer's and Dextrose Injection is a sterile solution of Calcium Chloride,Potassium Chloride,Sodium Chloride,Sodium Lactate,and Dextrose in Water for Injection.It contains,in each 100mL,not less than 57.0mg and not more than 63.0mg of sodium (as NaCl and C3H5NaO3),not less than 2.82mg and not more than 3.46mg of potassium (K,equivalent to not less than 5.4mg and not more than 6.6mg of KCl),not less than 0.98mg and not more than 1.20mg of calcium (Ca,equivalent to not less than 3.6mg and not more than 4.4mg of CaCl2·2H2O),not less than 73.6mg and not more than 85.6mg of chloride (Cl,as NaCl,KCl,and CaCl2·2H2O),and not less than 46.2mg and not more than 52.20mg of lactate (C3H5O3,equivalent to not less than 58.0mg and not more than 66.0mg of C3H5NaO3).It contains not less than 90.0percent and not more than 105.0percent of the labeled amount of dextrose (C6H12O6·H2O).It contains no antimicrobial agents.
NOTE—The calcium,potassium,and sodium contents of Modified Lactated Ringer's and Dextrose Injection are approximately 0.5,0.8,and 26milliequivalents 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.
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 4.0and 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 solution,Dilute hydrochloric acid,Blank solution,Calcium stock solution,and Standard preparations— Prepare as directed in the Assay for calciumunder Ringer's Injection.
Assay preparation— Transfer 5.0mLof Lanthanum chloride solutionto a 100-mLvolumetric flask,dilute with Injection 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:
0.105C,
in which Cis the concentration,in µg per mL,of calcium in the Assay preparation,as determined from the graph.
Assay for potassium—
Standard stock solution,Standard preparations,and Standard graph— Proceed as directed in the Assay for potassiumunder Ringer's Injection.
Assay preparation— Transfer 50.0mLof Injection to a 100-mLvolumetric flask,add 10.0mLof a solution of a suitable wetting agent (1in 500),dilute with water to volume,and mix.
Procedure— Adjust the instrument as directed under Standard graph,read the percentage transmittance of the Assay preparation,and calculate the potassium content,in mg per 100mL,of Injection.
Assay for sodium—
Standard stock solution and Standard preparations—Proceed as directed in the Assay for sodiumunder Ringer's Injection.
Assay preparation— Transfer 25.0mLof Injection to a 1000-mLvolumetric flask containing 100mLof a solution of a suitable wetting agent (1in 500),dilute with water to volume,and mix.
Procedure— Proceed as directed for Standard graphand for Procedurein the Assay for potassiumunder Ringer's Injection,setting the flame photometer for maximum transmittance at a wavelength of about 589nm,instead of about 766nm.Calculate the sodium content,in mg per 100mL,of Injection.
Assay for chloride— Proceed with Injection as directed in the Assay for chlorideunder Ringer's Injection.
Assay for lactate—
Mobile phase,Resolution solution,Chromatographic system,and Procedure— Proceed as directed in the Assay for lactateunder Lactated Ringer's Injection.
Standard preparation— Dissolve an accurately weighed quantity of USP Sodium Lactate RSin water to obtain a solution having a known concentration of about 0.6mg per mL.
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 1739
Phone Number:1-301-816-8379