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Multiple Electrolytes and Dextrose Injection Type 2
» Multiple Electrolytes and Dextrose Injection Type 2 is 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 provide ions of acetate, or acetate and citrate, or acetate and lactate, or gluconate and sulfate. It contains not less than 90.0 percent and not more than 110.0 percent 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 90.0 percent and not more than 120.0 percent of the labeled amount of chloride (Cl), and not less than 90.0 percent and not more than 105.0 percent 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 I or Type II glass.
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 L. When the contents are less than 100 mL, the label alternatively may state the total osmolar concentration in mOsmol per mL.
Identification—
A: It responds to the Identification test under Dextrose.
B: It responds to the flame tests for Sodium 191 and Potassium 191, to the tests for Magnesium 191 and Chloride 191, and to the oxalate test for Calcium 191.
C: Where acetate is purported to be present, the retention time of the acetate peak in the chromatogram of the Assay preparation corresponds to that in the chromatogram of the Standard preparation, as obtained 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 preparation corresponds to that in the chromatogram of the Standard preparation, as obtained 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 preparation corresponds to that in the chromatogram of the Standard preparation, as obtained 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 preparation corresponds to that in the chromatogram of the Standard preparation, as obtained in the Assay for gluconate.
G: Where sulfate is purported to be present, it responds to the barium chloride test for Sulfate 191.
Bacterial endotoxins 85— It contains not more than 0.5 USP Endotoxin Unit per mL.
pH 791: between 4.0 and 6.5.
Residual solvents 467: meets the requirements.
(Official January 1, 2007)
Other requirements— It meets the requirements under Injections 1.
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 sodium under Potassium Chloride in Sodium Chloride Injection.
Assay preparation— Transfer 5.0 mL of Injection to a 500-mL volumetric flask, dilute with Internal standard solution to volume, and mix.
Procedure— Proceed as directed for Procedure in the Assay for potassium and sodium under Potassium Chloride in Sodium Chloride Injection. Calculate the quantity, in mg, of potassium (K) in each mL of 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 0.02558 mEq of potassium. Calculate the quantity, in mg, of sodium (Na) in each mL of 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 0.04350 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 magnesium under Multiple Electrolytes Injection Type 1.
Assay preparation— Transfer an accurately measured volume of Injection, equivalent to about 20 mg (1.65 mEq) of magnesium, to a 1000-mL volumetric flask containing 50.0 mL of Lanthanum chloride solution. Dilute the contents of the flask with Dilute hydrochloric acid to volume, and mix.
Procedure— Proceed as directed for Procedure in the Assay for magnesium under Multiple Electrolytes Injection Type 1. Calculate the quantity, in µg, of magnesium (Mg) in each mL of the Injection taken by the formula:
1000(C/V),
in which V is 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 magnesium under Multiple Electrolytes Injection Type 1.
Calcium stock solution and Standard preparations— Prepare as directed in the Assay for calcium under Multiple Electrolytes Injection Type 2.
Assay preparation— Transfer an accurately measured volume of Injection, equivalent to about 20 mg (1 mEq) of calcium, to a 1000-mL volumetric flask containing 50.0 mL of Lanthanum chloride solution. Dilute the contents of the flask with Dilute hydrochloric acid to volume, and mix.
Procedure— Proceed as directed in the Assay for calcium under Multiple Electrolytes Injection Type 2. Calculate the quantity, in µg, of calcium in each mL of 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 chloride under Multiple Electrolytes Injection Type 1.
Assay for acetate (if present)—
Mobile phase, Standard preparation, and Chromatographic system— Prepare as directed in the Assay for acetate under Multiple Electrolytes Injection Type 1.
Assay preparation— Quantitatively dilute an accurately measured volume of Injection with water to obtain a solution containing about 0.0088 mEq of acetate per mL.
Procedure— Proceed as directed for Procedure in the Assay for acetate under 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 citrate under Multiple Electrolytes Injection Type 2.
Assay preparation— Where the labeled quantity is greater than 10 mEq of citrate per L, dilute an accurately measured volume of Injection quantitatively with water to obtain a solution containing about 0.01 mEq of citrate per mL. Where the labeled quantity is 10 mEq or less per liter, use the undiluted Injection as the Assay preparation.
Procedure— Proceed as directed for Procedure in the Assay for citrate under Multiple Electrolytes Injection Type 2. Calculate the quantity, in mEq per L, 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 lactate under Multiple Electrolytes Injection Type 2.
Assay preparation— Where the labeled quantity of lactate is greater than 20 mEq per L, quantitatively dilute an accurately measured volume of Injection with water to obtain a solution containing about 0.02 mEq of lactate per mL. Where the labeled quantity of lactate is 20 mEq or less per L, use the undiluted Injection as the Assay preparation.
Procedure— Proceed as directed for Procedure in the Assay for lactate under Multiple Electrolytes Injection Type 2. Calculate the quantity, in mEq per L, 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, and Chromatographic system— Prepare as directed in the Assay for gluconate under Multiple Electrolytes and Dextrose Injection Type 1.
Assay preparation— Quantitatively dilute an accurately measured volume of Injection with water to obtain a solution containing about 0.023 mEq of gluconate per mL.
Procedure— Proceed as directed for Procedure in the Assay for gluconate under Multiple Electrolytes and Dextrose Injection Type 1. Calculate the quantity, in mEq per L, 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 sulfate under Multiple Electrolytes Injection Type 1.
Assay for dextrose— Using the Injection, proceed as directed in the Assay for dextrose under Multiple Electrolytes and Dextrose Injection Type 1.
Auxiliary Information— Staff Liaison : Daniel K. Bempong, Ph.D., Scientist
Expert Committee : (MDPS05) Monograph Development-Pulmonary and Steroids
USP29–NF24 Page 786
Pharmacopeial Forum : Volume No. 31(3) Page 760
Phone Number : 1-301-816-8143