Multiple Electrolytes and Dextrose Injection Type 4
»Multiple Electrolytes and Dextrose Injection Type 4is a sterile solution of Dextrose and suitable salts in Water for Injection to provide sodium,magnesium,calcium,chloride,gluconate,and sulfate ions.It contains not less than 90.0percent and not more than 110.0percent of the labeled amounts of sodium (Na),magnesium (Mg),calcium (Ca),gluconate (C6H11O7),and sulfate (SO4),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 test for Sodium á191ñ,to the tests for Magnesium á191ñand Chloride á191ñ,to the oxalate test for Calcium á191ñ,and to the barium chloride test for Sulfate á191ñ.
C: 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.
Bacterial endotoxins á85ñ It contains not more than 0.5USP Endotoxin Unit per mL.
pHá791ñ: between 4.2and 5.2.
Other requirements— It meets the requirements under Injections á1ñ.
Assay for sodium—
Internal standard solution— Transfer 1.04g of lithium nitrate to a 1000-mLvolumetric flask,add a suitable nonionic surfactant,dilute with water to volume,and mix.
Standard preparation— Transfer 7.31g of sodium chloride,previously dried at 105for 2hours and accurately weighed,to a 250-mLvolumetric flask,dilute with water to volume,and mix.Transfer 10.0mLof this solution to a 100-mLvolumetric flask,dilute with water to volume,and mix.Transfer 5.0mLof this solution to a 500-mLvolumetric flask,dilute with Internal standard solutionto volume,and mix.Each mLof this solution contains 0.0292mg of sodium chloride,equivalent to 0.0115mg (0.0005mEq)of sodium (Na).
Assay preparation— Dilute an accurately measured volume of Injection quantitatively with Internal standard solutionto obtain a solution containing about 0.0115mg (0.0005mEq)of sodium per mL.
Procedure— Using a flame photometer,adjusted to read zero with Internal standard solution,concomitantly determine the flame emission readings for the Standard preparationand the Assay preparationat the wavelengths of maximum emission for sodium and lithium (589nm and 671nm,respectively).Calculate the quantity,in mg,of sodium (Na)in each mLof the Injection taken by the formula:
(22.99/58.44)(C)(L/D)(RU,589/RU,671)(RS,671/RS,589),
in which 22.99is the atomic weight of sodium,58.44is the molecular weight of sodium chloride,Cis the concentration,in mg per mL,of sodium chloride in the Standard preparation,Lis the labeled quantity,in mg,of sodium in each mLof the Injection,Dis the concentration,in mg per mL,of sodium in the Assay preparation,based on the volume of Injection taken and the extent of dilution,and RU,589and RU,671are the emission readings at the wavelengths identified by the subscript numbers obtained for the Assay preparation,and RS,589and RS,671are the emission readings at the wavelengths identified by the subscript numbers obtained from the Standard preparation.Each mg of sodium is equivalent to 0.0435of mEq 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 Injection taken by the formula:
1000(C/V),
in which the terms are as defined therein.
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 for Procedurein the Assay for calciumunder Multiple Electrolytes Injection Type 2.Calculate the quantity,in µg,of calcium in each mLof 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 gluconate—
Mobile phase,Standard preparation,Resolution solution,and Chromatographic 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— Using the Injection,proceed as directed in the Assay for sulfateunder Multiple Electrolytes and Dextrose 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 723
Phone Number:1-301-816-8379