Multiple Electrolytes and Dextrose Injection Type 4
» Multiple Electrolytes and Dextrose Injection Type 4 is a sterile solution of Dextrose and suitable salts in Water for Injection to provide sodium, magnesium, calcium, chloride, gluconate, and sulfate ions. It contains not less than 90.0 percent and not more than 110.0 percent of the labeled amounts of sodium (Na), magnesium (Mg), calcium (Ca), gluconate (C6H11O7), 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 test for Sodium 191, to the tests for Magnesium 191 and Chloride 191, to the oxalate test for Calcium 191, and to the barium chloride test for Sulfate 191.
C:
The retention time of the gluconate peak in the chromatogram of the Assay preparation corresponds to that of the Standard preparation obtained as directed in the Assay for gluconate.
Bacterial endotoxins 85
It contains not more than 0.5 USP Endotoxin Unit per mL.
pH 791:
between 4.2 and 5.2.
Other requirements
It meets the requirements under Injections 1.
Assay for sodium
Internal standard solution
Transfer 1.04 g of lithium nitrate to a 1000-mL volumetric flask, add a suitable nonionic surfactant, dilute with water to volume, and mix.
Standard preparation
Transfer 7.31 g of sodium chloride, previously dried at 105 for 2 hours and accurately weighed, to a 250-mL volumetric flask, dilute with water to volume, and mix. Transfer 10.0 mL of this solution to a 100-mL volumetric flask, dilute with water to volume, and mix. Transfer 5.0 mL of this solution to a 500-mL volumetric flask, dilute with Internal standard solution to volume, and mix. Each mL of this solution contains 0.0292 mg of sodium chloride, equivalent to 0.0115 mg (0.0005 mEq) of sodium (Na).
Assay preparation
Dilute an accurately measured volume of Injection quantitatively with Internal standard solution to obtain a solution containing about 0.0115 mg (0.0005 mEq) of sodium per mL.
Procedure
Using a flame photometer, adjusted to read zero with Internal standard solution, concomitantly determine the flame emission readings for the Standard preparation and the Assay preparation at the wavelengths of maximum emission for sodium and lithium (589 nm and 671 nm, respectively). Calculate the quantity, in mg, of sodium (Na) in each mL of the Injection taken by the formula:
(22.99 / 58.44)(C)(L / D)(RU,589 / RU,671)(RS,671 / RS,589)
in which 22.99 is the atomic weight of sodium, 58.44 is the molecular weight of sodium chloride, C is the concentration, in mg per mL, of sodium chloride in the Standard preparation, L is the labeled quantity, in mg, of sodium in each mL of the Injection, D is the concentration, in mg per mL, of sodium in the Assay preparation, based on the volume of Injection taken and the extent of dilution, and RU,589 and RU,671 are the emission readings at the wavelengths identified by the subscript numbers obtained for the Assay preparation, and RS,589 and RS,671 are the emission readings at the wavelengths identified by the subscript numbers obtained from the Standard preparation. Each mg of sodium is equivalent to 0.0435 of mEq of sodium.
Assay for magnesium
[noteConcentrations 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 preparationsPrepare 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 Injection taken by the formula:
1000(C / V)
in which the terms are as defined therein.
Assay for calcium
[noteConcentrations 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 for Procedure in the Assay for calcium under Multiple Electrolytes Injection Type 2. Calculate the quantity, in µg, of calcium in each mL of 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 gluconate
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
Dilute an accurately measured volume of Injection quantitatively 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 liter, 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
Using the Injection, proceed as directed in the Assay for sulfate under Multiple Electrolytes and Dextrose 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
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USP35NF30 Page 3023
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