Multiple Electrolytes and Dextrose Injection Type 3, chemical structure, molecular formula, Reference Standards

Multiple Electrolytes and Dextrose Injection Type 3

»Multiple Electrolytes and Dextrose Injection Type 3is a sterile solution of Dextrose and suitable salts in Water for Injection to provide sodium,potassium,and chloride ions.In addition,the salts may provide ions of ammonium,or acetate and phosphate,or phosphate and lactate.It contains not less than 90.0percent and not more than 110.0percent of the labeled amounts of sodium (Na),potassium (K),ammonium (NH4),acetate (C2H3O2),phosphate (PO4),and lactate (C3H5O3),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.

USP Reference standards á11ñ— USP Endotoxin RS.USP Sodium Lactate RS.

Identification—

A: It responds to the Identificationtest under Dextrose.

B: It responds to the flame tests for Sodium á191ñand Potassium á191ñ,and to the tests for Chloride á191ñand Ammonium 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 phosphate is purported to be present,add 5mLof the Injection and 1mLof ammonium molybdate TSto a test tube,and mix:a yellow precipitate,which is soluble in 6Nammonium hydroxide,is formed.

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.

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 chloride— Using the Injection,proceed as directed in the Assay for chlorideunder Multiple Electrolytes Injection Type 1.

Assay for ammonium (if present)— Transfer an accurately measured volume of Injection,equivalent to about 63mg (3.5mEq)of ammonium,to a 500-mL Kjeldahl flask,dilute with water to 200mL,mix,and add 50mLof sodium hydroxide solution (2in 5).Immediately connect the flask by means of a distillation trap to a well-cooled condenser,the delivery tube of which dips into 40mLof boric acid solution (1in 25)contained in a suitable receiver.Heat to boiling,and distill about 200mL.Cool the liquid in the receiver,if necessary,then add methyl red TS,and titrate with 0.1Nsulfuric acid VS.Perform a blank determination,and make any necessary correction.Each mLof 0.1Nsulfuric acid is equivalent to 1.804mg (0.1mEq)of ammonium (NH4).

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 phosphate (if present)—

Ammonium molybdate solution,Hydroquinone solution,Sodium sulfite solution,Standard preparation,and Blank— Prepare as directed in the Assay for phosphateunder Multiple Electrolytes Injection Type 1.

Assay preparation— Transfer an accurately measured volume of Injection,equivalent to about 4mg (0.126mEq)of phosphate,to a 50-mLvolumetric flask,dilute with water to volume,and mix.

Procedure— Proceed as directed for Procedurein the Assay for phosphateunder Multiple Electrolytes Injection Type 1.Calculate the quantity,in mg,of phosphate (PO4)in each mLof the Injection taken by the formula:

50(94.97/136.09)(C/V)(AU/AS),

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 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 722

Pharmacopeial Forum:Volume No.30(3)Page 839

Phone Number:1-301-816-8379