Multiple Electrolytes and Dextrose Injection Type 2
»Multiple Electrolytes and Dextrose Injection Type 2is a sterile solution of Dextrose and suitable salts in Water for Injection to provide sodium,potassium,magnesium,calcium,and chloride ions.In addition,the salts may provide ions of acetate,or acetate and citrate,or acetate and lactate,or gluconate and sulfate.It contains not less than 90.0percent and not more than 110.0percent of the labeled amounts of sodium (Na),potassium (K),magnesium (Mg),calcium (Ca),acetate (C2H3O2),citrate (C6H5O7),lactate (C3H5O3),gluconate (C6H11O7),and sulfate (SO4),and not less than 90.0percent and not more than 120.0percent of the labeled amount of chloride (Cl),and not less than 90.0percent and not more than 105.0percent of the labeled amount of dextrose (C6H12O6·H2O).It may contain Hydrochloric Acid or Sodium Hydroxide used to adjust the pH.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 content of each electrolyte in terms of milliequivalents in a given volume.The label states the total osmolar concentration in mOsmol per liter.When 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 Identificationtest under Dextrose.
B: It responds to the flame tests for Sodium á191ñand Potassium á191ñ,to the tests for Magnesium á191ñand Chloride á191ñ,and to the oxalate test for Calcium á191ñ.
C: Where acetate is purported to be present,the retention time of the acetate peak in the chromatogram of the Assay preparationcorresponds to that of the Standard preparationobtained as directed in the Assay for acetate.
D: Where citrate is purported to be present,the retention time of the citrate peak in the chromatogram of the Assay preparationcorresponds to that of the Standard preparationobtained as directed in the Assay for citrate.
E: Where lactate is purported to be present,the retention time of the lactate peak in the chromatogram of the Assay preparationcorresponds to that of the Standard preparationobtained as directed in the Assay for lactate.
F: Where gluconate is purported to be present,the retention time of the gluconate peak in the chromatogram of the Assay preparationcorresponds to that of the Standard preparationobtained as directed in the Assay for gluconate.
G: Where sulfate is purported to be present,it responds to the barium chloride test for Sulfate á191ñ.
Bacterial endotoxins á85ñ— It contains not more than 0.5USP Endotoxin Unit per mL.
pHá791ñ: between 4.0and 6.5.
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 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.Calculate the quantity,in mg,of potassium (K)in each mLof the Injection taken by the formula:
C(RU,766/RU,671)(RS,671/RS,766),
in which the terms are as defined therein.Each mg of potassium is equivalent to 0.02558mEq of potassium.Calculate the quantity,in mg,of sodium (Na)in each mLof the Injection taken by the formula:
C(RU,589/RU,671)(RS,671/RS,589),
in which the terms are as defined therein.Each mg of sodium is equivalent to 0.04350mEq of sodium.
Assay for magnesium— [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,Magnesium stock solution,and Standard preparations— Prepare as directed in the Assay for magnesiumunder Multiple Electrolytes Injection Type 1.
Assay preparation— Transfer an accurately measured volume of Injection,equivalent to about 20mg (1.65mEq)of magnesium,to a 1000-mLvolumetric flask containing 50.0mLof Lanthanum chloride solution.Dilute the contents of the flask with Dilute hydrochloric acidto volume,and mix.
Procedure— Proceed as directed for Procedurein the Assay for magnesiumunder Multiple Electrolytes Injection Type 1.Calculate the quantity,in µg,of magnesium (Mg)in each mLof the Injection taken by the formula:
1000(C/V),
in which Vis the volume,in mL,of Injection taken to prepare the Assay preparation.
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,and Blank solution— Prepare as directed in the Assay for magnesiumunder Multiple Electrolytes Injection Type 1.
Calcium stock solution and Standard preparations— Prepare as directed in the Assay for calciumunder Multiple Electrolytes Injection Type 2.
Assay preparation— Transfer an accurately measured volume of Injection,equivalent to about 20mg (1mEq)of calcium,to a 1000-mLvolumetric flask containing 50.0mLof Lanthanum chloride solution.Dilute the contents of the flask with Dilute hydrochloric acidto volume,and mix.
Procedure— Proceed as directed in the Assay for calciumunder Multiple Electrolytes Injection Type 2.Calculate the quantity,in µg,of calcium in each mLof the Injection taken by the formula:
1000(C/V),
in which the terms are as defined therein.
Assay for chloride— Using the Injection,proceed as directed in the Assay for chlorideunder Multiple Electrolytes Injection Type 1.
Assay for acetate (if present)—
Mobile phase,Standard preparation,and Chromatographic system— Prepare as directed in the Assay for acetateunder Multiple Electrolytes Injection Type 1.
Assay preparation— Dilute an accurately measured volume of Injection quantitatively with water to obtain a solution containing about 0.0088mEq of acetate per mL.
Procedure— Proceed as directed for Procedurein the Assay for acetateunder Multiple Electrolytes Injection Type 1.Calculate the quantity,in mEq per liter,of acetate (C2H3O2)in the Injection taken by the formula:
(C/136.08)(L/D)(rU/rS),
in which the terms are as defined therein.
Assay for citrate (if present)—
Mobile phase,Standard preparations,and Chromatographic system— Prepare as directed in the Assay for citrateunder Multiple Electrolytes Injection Type 2.
Assay preparation— Where the labeled quantity is greater than 10mEq of citrate per liter,dilute an accurately measured volume of Injection quantitatively with water to obtain a solution containing about 0.01mEq of citrate per mL.Where the labeled quantity is 10mEq or less per liter,use the undiluted Injection as the Assay preparation.
Procedure— Proceed as directed for Procedurein the Assay for citrateunder Multiple Electrolytes Injection Type 2.Calculate the quantity,in mEq per liter,of citrate (C6H5O7)in the Injection taken by the formula:
(C/258.07)(L/D),
in which the terms are as defined therein.
Assay for lactate (if present)—
Mobile phase,Resolution solution,Standard preparation,and Chromatographic system— Prepare as directed in the Assay for lactateunder Multiple Electrolytes Injection Type 2.
Assay preparation— Where the labeled quantity of lactate is greater than 20mEq per liter,dilute an accurately measured volume of Injection quantitatively with water to obtain a solution containing about 0.02mEq of lactate per mL.Where the labeled quantity of lactate is 20mEq or less per liter,use the undiluted Injection as the Assay preparation.
Procedure— Proceed as directed for Procedurein the Assay for lactateunder Multiple Electrolytes Injection Type 2.Calculate the quantity,in mEq per liter,of lactate (C3H5O3)in the Injection taken by the formula:
(C/112.06)(L/D)(rU/rS),
in which the terms are as defined therein.
Assay for gluconate (if present)—
Mobile phase,Standard preparation,Resolution solution,andChromatographic system— Prepare as directed in the Assay for gluconateunder Multiple Electrolytes and Dextrose Injection Type 1.
Assay preparation— Dilute an accurately measured volume of Injection quantitatively with water to obtain a solution containing about 0.023mEq of gluconate per mL.
Procedure— Proceed as directed for Procedurein the Assay for gluconateunder Multiple Electrolytes and Dextrose Injection Type 1.Calculate the quantity,in mEq per liter,of gluconate (C6H11O7)in the Injection taken by the formula:
(C/234.25)(L/D)(rU/rS),
in which the terms are as defined therein.
Assay for sulfate (if present)— Using the Injection,proceed as directed in the Assay for sulfateunder Multiple Electrolytes Injection Type 1.
Assay for dextrose— Using the Injection,proceed as directed in the Assay for dextroseunder Multiple Electrolytes and Dextrose Injection Type 1.
Auxiliary Information— Staff Liaison:Karen A Russo,Ph.D.,Scientist
Expert Committee:(PA1)Pharmaceutical Analysis 1
USP28–NF23Page 720
Pharmacopeial Forum:Volume No.30(3)Page 838
Phone Number:1-301-816-8379