Multiple Electrolytes and Dextrose Injection Type 1
» Multiple Electrolytes and Dextrose Injection Type 1 is a sterile solution of Dextrose and suitable salts in Water for Injection to provide sodium, potassium, magnesium, and chloride ions. In addition, the salts provide ions of acetate, or acetate and gluconate, or acetate and phosphate, or phosphate and lactate, or phosphate 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), acetate (C2H3O2), gluconate (C6H11O7), phosphate (PO4), lactate (C3H5O3), and sulfate (SO4), 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 Magnesium 191 and Chloride 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 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.
E: Where phosphate is purported to be present, add 5 mL of 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.
F: 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.
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.
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 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 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 gluconate (if present)—
Mobile phase— Dissolve 7.0 g of calcium acetate in 1900 mL of water, and adjust with glacial acetic acid to a pH of 4.5 ± 0.1. Dilute with water to 2000 mL, mix, pass through a filter having a 0.5-µm porosity or finer, and degas. Make adjustments if necessary (see System Suitability under Chromatography 621). Maintain the Mobile phase at 70 ± 2 at all times.
Standard preparation— Quantitatively dissolve an accurately weighed quantity of USP Potassium Gluconate RS in water to obtain a solution having a known concentration of about 4.6 mg per mL.
Resolution solution— Prepare an aqueous solution containing about 5 mg each of USP Sodium Lactate RS and USP Potassium Gluconate RS per mL.
Assay preparation— Quantitatively dilute an accurately measured volume of Injection with water, if necessary, to obtain a solution containing about 0.023 mEq of gluconate per mL.
Chromatographic system (see Chromatography 621)— The liquid chromatograph is equipped with a refractive index detector and a 7.8-mm × 30-cm column that contains packing L19 in the calcium form and is maintained at 70 ± 2. The flow rate is about 1 mL per minute. Condition the column for about 60 minutes by pumping Mobile phase through it. Chromatograph the Resolution solution, and record the peak responses as directed for Procedure: the resolution R, between lactate and gluconate is not less than 4.0. Chromatograph the Standard preparation, and record the peak responses as directed for Procedure: the relative standard deviation for replicate injections is not more than 2.0%.
Procedure— Separately inject equal volumes (about 50 µL) of the Standard preparation and the Assay preparation into the chromatograph, record the chromatograms, and measure the responses for the major peaks. 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 C is the concentration, in mg per mL, of USP Potassium Gluconate RS in the Standard preparation; 234.25 is the molecular weight of potassium gluconate; L is the labeled quantity, in mEq per L, of gluconate in the Injection; D is the quantity, in mEq per L, of gluconate in the Assay preparation, based on the labeled quantity and the extent of dilution, if any; and rU and rS are the gluconate peak responses for the Assay preparation and the Standard preparation, respectively.
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(94.97/136.08)(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 sulfate (if present)— Transfer an accurately measured volume of Injection, equivalent to about 120 mg (1.22 mEq) of sulfate, to a suitable vessel. Dilute if necessary to 200 mL, and add 1 mL of hydrochloric acid. Heat to boiling, and gradually add, in small portions and while constantly stirring, an excess of hot barium chloride TS (about 8 mL). Heat the mixture on a steam bath for 1 hour, collect the precipitate of barium sulfate on a tared filtering crucible, wash until free from chloride, dry, ignite, and weigh. The weight of the barium sulfate so obtained, multiplied by 0.4116, represents its equivalent of sulfate (SO4). Each mg of barium sulfate represents 0.004285 mEq of sulfate.
Assay for dextrose— Transfer an accurately measured volume of Injection, containing 2 to 5 g of dextrose, to a 100-mL volumetric flask. Add 0.2 mL of 6 N ammonium hydroxide, dilute with water to volume, and mix. Determine the angular rotation in a polarimeter tube (see Optical Rotation 781). Calculate the percentage (g per 100 mL) of dextrose (C6H12O6·H2O) in the portion of Injection taken by the formula:
(100/52.9)(198.17/180.16)AR
in which 100 is the percentage; 52.9 is the midpoint of the specific rotation range for anhydrous dextrose, in degrees; 198.17 and 180.16 are the molecular weights for dextrose monohydrate and anhydrous dextrose, respectively; A is 100 mm divided by the length of the polarimeter tube, in mm; and R is the observed rotation, in degrees.
Auxiliary Information— Please check for your question in the FAQs before contacting USP.
Topic/Question Contact Expert Committee
Monograph Daniel K. Bempong, Ph.D.
Senior Scientist
1-301-816-8143		 (MDPS05) Monograph Development-Pulmonary and Steroids
Reference Standards Lili Wang, Technical Services Scientist
1-301-816-8129
RSTech@usp.org
85 Radhakrishna S Tirumalai, Ph.D.
Senior Scientist
1-301-816-8339		 (MSA05) Microbiology and Sterility Assurance
USP32–NF27 Page 2235
Pharmacopeial Forum: Volume No. 30(5) Page 1616
Chromatographic Column—
Chromatographic columns text is not derived from, and not part of, USP 32 or NF 27.