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.

(Official January 1, 2007)

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: 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.

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 Injection taken by the formula: in which the terms are as defined therein.

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: in which the terms are as defined therein.

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: in which the terms are as defined therein.