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.
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.
]
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.
Assay for acetate (if present)—
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 (C
2H
3O
2)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)—
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.
Assay for lactate (if present)—
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 (C
3H
5O
3)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)—
Assay preparation—
Dilute an accurately measured volume of Injection quantitatively with water to obtain a solution containing about 0.023mEq of gluconate per mL.