Multiple Electrolytes and Invert Sugar Injection Type 1
»Multiple Electrolytes and Invert Sugar Injection Type 1is a sterile solution of a mixture of equal amounts of Dextrose and Fructose,or an equivalent solution produced by the hydrolysis of Sucrose,and suitable salts in Water for Injection to provide sodium,potassium,magnesium,chloride,phosphate,and lactate ions.It contains not less than 90.0percent and not more than 110.0percent of the labeled amounts of sodium (Na),potassium (K),magnesium (Mg),phosphate (PO4),lactate (C3H5O3),and invert sugar (C6H12O6),and not less than 90.0percent and not more than 120.0percent of the labeled amount of chloride (Cl).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 Invert Sugar Injection.
B: It responds to the flame tests for Sodium á191ñand Potassium á191ñ,and to the tests for Magnesium á191ñand Chloride á191ñ.
C: 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 (presence of phosphate).
D: 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.
Pyrogen— It meets the requirements of the Pyrogen Test á151ñ.[NOTE—Dilute,with Water for Injection,Injection containing more than 10%of invert sugar to give a concentration of 10%invert sugar.]
pHá791ñ: between 3.0and 6.0.
Completeness of inversion—
Mobile phase,Standard preparation,and Chromatographic system— Prepare as directed in the test for Completeness of inversionunder Invert Sugar Injection.
Test preparation— Transfer an accurately measured volume of Injection,equivalent to about 2.5g of invert sugar,to a 100-mLvolumetric flask,dilute with water to volume,and mix.
Procedure— Proceed as directed for Procedurein the test for Completeness of inversionunder Invert Sugar Injection.Calculate the quantity,in mg,of sucrose in the volume of the Injection taken by the formula:
100C(rU/rS),
in which the terms are as defined therein.Not more than 1.5%of the quantity of invert sugar in the volume of the Injection taken,based on the labeled amount,is found.
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 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 phosphate—
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—
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 invert sugar— Tare a clean,medium-porosity filtering crucible containing several carborundum boiling chips or glass beads.Transfer 50.0mLof freshly mixed alkaline cupric tartrate TSto a 400-mLbeaker.To the beaker add the boiling chips or glass beads from the tared crucible,48mLof water,and 2.0mLof Injection that has been diluted quantitatively with water,if necessary,to a 5.0%concentration of invert sugar.Heat the beaker and contents over a burner that has been adjusted to cause boiling of the solution to start in 3.5to 4minutes.Boil the solution for 2.0minutes,accurately timed,and filter immediately through the tared crucible,taking care to transfer all of the boiling chips or glass beads to the crucible.Wash the precipitate with hot water and 10mLof alcohol.Dry the crucible and contents at 110to constant weight,and make any necessary correction.The corrected weight of the precipitate so obtained is not less than 193.6mg and not more than 234.5mg,corresponding to between 90.0and 110.0mg of invert sugar (C6H12O6).
Auxiliary Information— Staff Liaison:Karen A Russo,Ph.D.,Scientist
Expert Committee:(PA1)Pharmaceutical Analysis 1
USP28–NF23Page 724
Phone Number:1-301-816-8379