Lactated Ringer's Injection
»Lactated Ringer's 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 14.2mg and not more than 17.3mg of potassium (K,equivalent to not less than 27.0mg and not more than 33.0mg of KCl),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),not less than 368.0mg and not more than 408.0mg of chloride (Cl,as NaCl,KCl,and 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).Lactated Ringer's Injection contains no antimicrobial agents.
NOTE—The calcium,potassium,and sodium contents of Lactated Ringer's Injection are approximately 2.7,4,and 130milliequivalents 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 flame tests for Sodium á191ñand for Potassium á191ñ,to the ammonium oxalate test for Calcium á191ñ,and to the tests for Chloride á191ñ.
B: 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 6.0and 7.5.
Heavy metals á231ñ— Evaporate 67mLto a volume of 20mL,add 2mLof 1Nacetic acid,then dilute with water to 25mL:the limit is 0.3ppm.
Other requirements— It meets the requirements under Injections á1ñ.
Assay for calcium— Proceed with Injection as directed in the Assay for calciumunder Ringer's Injection.
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— Prepare a solution in water containing about 1mLof formic acid and 1mLof dicyclohexylamine per liter,filter,and degas.Make adjustments if necessary (see System Suitabilityunder Chromatography á621ñ).
Resolution solution— Prepare a solution in water containing about 3mg of anhydrous sodium acetate and 3mg of USP Sodium Lactate RSper mL.
Standard preparation— Dissolve an accurately weighed quantity of USP Sodium Lactate RSin water to obtain a solution having a known concentration of about 3mg per mL.
Assay preparation— Use undiluted Injection.
Chromatographic system (see Chromatography á621ñ)—The liquid chromatograph is equipped with a 210-nm detector and a 4.6-mm ×10-cm column that contains packing L1.The flow rate is about 1mLper minute.Chromatograph the Resolution solution,and record the peak responses as directed for Procedure:the resolution,R,between the acetate peak and the lactate peak is not less than 2.Chromatograph the Standard preparation,and record the responses as directed for Procedure:the tailing factor for the analyte peak is not more than 2.0,and the relative standard deviation for replicate injections is not more than 2.0%.
Procedure— Separately inject equal volumes (about 20µL)of the Standard preparationsand the Assay preparationinto the chromatograph,record the chromatograms,and measure the responses for the major peaks.Calculate the quantity,in mg,of lactate (C3H5O3)in the Injection taken by the formula:
C(89.07/112.06)(rU/rS),
in which Cis the concentration,in mg per mL,of USP Sodium Lactate RSin the Standard preparation,89.07and 112.06are the molecular weights of lactate (C3H5O3)and anhydrous sodium lactate (C3H5NaO3),respectively,and rUand rSare the lactate peak responses obtained from the Assay preparationand the Standard preparation,respectively.
Auxiliary Information— Staff Liaison:Karen A Russo,Ph.D.,Scientist
Expert Committee:(PA1)Pharmaceutical Analysis 1
USP28–NF23Page 1737
Phone Number:1-301-816-8379