Packaging and storage—
Preserve in single-dose containers, preferably of Type I or Type II glass, or of a suitable plastic material.
Labeling—
The label states the total osmolar concentration in mOsmol per L.
Identification—
Add a few drops of Injection to 5 mL of hot alkaline cupric tartrate TS: a copious red precipitate of cupric oxide is formed.
Chloride 
221
—
A 2.0-mL portion shows no more chloride than corresponds to 0.34 mL of 0.020 N hydrochloric acid (0.012%).
Heavy metals 231—
Transfer a volume of Injection, equivalent to 4.0 g of invert sugar, to a suitable vessel, and adjust the volume to 25 mL by evaporation: the limit is 0.0005
C%, in which
C is the labeled amount, in g, of invert sugar per mL of Injection.
Limit of 5-hydroxymethylfurfural and related substances—
Dilute an accurately measured volume of Injection, equivalent to 1.0 g of invert sugar, with water to 500.0 mL. Determine the absorbance of this solution in a 1-cm cell at 284 nm, with a suitable spectrophotometer, using water as the blank: the absorbance is not more than 0.25.
Completeness of inversion—
Mobile phase—
Use filtered, degassed water.
Standard preparation—
Prepare a solution in water containing known concentrations of about 0.25 mg of sucrose and about 12.5 mg of dextrose per mL.
Test preparation—
Transfer a volume of Injection, equivalent to about 2.5 g of invert sugar, to a 100-mL volumetric flask, dilute with water to volume, and mix.
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 9-µm packing L19, maintained at a constant temperature of about 40
. Chromatograph the
Standard preparation, and record the peak responses as directed for
Procedure: the sucrose elutes first, and the peak is baseline separated from the dextrose peak. The relative standard deviation for replicate injections is not more than 2.0%.
Procedure—
Separately inject equal volumes (about 20 µL) of the
Standard preparation and the
Test preparation into the chromatograph, record the chromatograms, and measure the responses for the sucrose peaks. Calculate the quantity, in mg, of sucrose, in the volume of the Injection taken by the formula:
100C(rU / rS),
in which
C is the concentration, in mg per mL, of sucrose in the
Standard preparation, and
rU and
rS are the peak responses for sucrose obtained from the
Test preparation and the
Standard preparation, respectively: not more than 1.5% of the quantity of invert sugar in the volume of Injection taken, based on the value stated on the label, is found.
Other requirements—
It meets the requirements under
Injections 1.
Assay—
Pipet 50 mL of
alkaline cupric tartrate TS into a 400-mL beaker, add 48 mL of water, mix, and pipet into the mixture 2 mL of Injection that has been diluted quantitatively with water, if necessary, to a 5.0% concentration. Cover the beaker with a watch glass, heat the solution, regulating the heat so that boiling begins in 4 minutes, and continue boiling for 2.0 minutes. Filter the hot solution at once through a tared porcelain filtering crucible, wash the precipitate with water maintained at 60
, then with 10 mL of alcohol. Dry at 105
to constant weight. Perform a blank determination, and make any necessary correction. The corrected weight of the precipitate so obtained is not less than 204.0 mg and not more than 224.4 mg, corresponding to between 95.0 and 105.0 mg of C
6H
12O
6.
