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Multiple Electrolytes and Dextrose Injection Type 3
» Multiple Electrolytes and Dextrose Injection Type 3 is a sterile solution of Dextrose and suitable salts in Water for Injection to provide sodium, potassium, and chloride ions. In addition, the salts provide ions of ammonium, or acetate and phosphate, or phosphate and lactate. It contains not less than 90.0 percent and not more than 110.0 percent of the labeled amounts of sodium (Na), potassium (K), ammonium (NH4), acetate (C2H3O2), phosphate (PO4), and lactate (C3H5O3), 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, and to the tests for Chloride 191 and Ammonium 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 of the Standard preparation, obtained as directed in the Assay for acetate.
D: Where phosphate is purported to be present, add 5 mL of the Injection and 1 mL of ammonium molybdate TS to a test tube, and mix: a yellow precipitate, which is soluble in 6 N ammonium hydroxide, is formed.
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.
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 chloride— Using the Injection, proceed as directed in the Assay for chloride under Multiple Electrolytes Injection Type 1.
Assay for ammonium (if present)— Transfer an accurately measured volume of Injection, equivalent to about 63 mg (3.5 mEq) of ammonium, to a 500-mL Kjeldahl flask, dilute with water to 200 mL, mix, and add 50 mL of sodium hydroxide solution (2 in 5). Immediately connect the flask by means of a distillation trap to a well-cooled condenser, the delivery tube of which dips into 40 mL of boric acid solution (1 in 25) contained in a suitable receiver. Heat to boiling, and distill about 200 mL. Cool the liquid in the receiver, if necessary, then add methyl red TS, and titrate with 0.1 N sulfuric acid VS. Perform a blank determination, and make any necessary correction. Each mL of 0.1 N sulfuric acid is equivalent to 1.804 mg (0.1 mEq) of ammonium (NH4).
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 L, 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 phosphate under Multiple Electrolytes Injection Type 1.
Assay preparation— Transfer an accurately measured volume of Injection, equivalent to about 4 mg (0.126 mEq) of phosphate, to a 50-mL volumetric flask, dilute with water to volume, and mix.
Procedure— Proceed as directed for Procedure in the Assay for phosphate under Multiple Electrolytes Injection Type 1. Calculate the quantity, in mg, of phosphate (PO4) in each mL of 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 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 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 788
Pharmacopeial Forum : Volume No. 30(3) Page 839
Phone Number : 1-301-816-8143