Packaging and storage—
Preserve in single-dose glass or plastic containers.
Labeling—
The label states the total osmolar concentration in mOsmol per L. Where the contents are less than 100 mL, the label alternatively may state the total osmolar concentration in mOsmol per mL.
Color of solution—
Its absorbance, determined at 375 nm against a water blank, is not greater than 0.06.
Identification—
Dilute a portion quantitatively with dextrose solution (4.5 in 100) to a concentration of about 10 mg of Dextran 40 per mL. Using a capillary tube viscosimeter having dimensions such that the flow time of water is not less than 100 seconds, measure the flow times of the diluted Injection and that of a dextrose solution (4.5 in 100) at 20
. Calculate the intrinsic viscosity by the formula:
{ln[(RD)(t / t0)]} / C,
in which
RD is the ratio of the density of the diluted Injection to that of the dextrose solution;
t and
t0 are the flow times for the diluted Injection and the dextrose solution, respectively; and
C is the concentration, in g per mL, of Dextran 40 in the diluted Injection: the intrinsic viscosity is between 18 and 23 mL per g.
Heavy metals, Method II 
231
:
5 µg per mL.
Limit of 5-hydroxymethylfurfural and related substances—
Dilute an accurately measured volume of Injection, equivalent to 1.0 g of C6H12O6·H2O, with water to 500.0 mL. Determine the absorbance of this solution in a 1-cm cell at 284 nm, using water as the blank: the absorbance is not more than 0.25.
Assay for dextrose—
Mobile phase—
Use filtered and degassed 0.01 N sulfuric acid.
System suitability preparation—
Prepare a solution in water containing 5 mg each of dextrose and xylitol per mL.
Standard preparation—
Dissolve an accurately weighed quantity of
USP Dextrose RS in water to obtain a solution having a known concentration of about 5 mg of dextrose monohydrate per mL.
Assay preparation—
Transfer an accurately measured volume of Injection, equivalent to about 250 mg of dextrose monohydrate, to a 50-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 containing packing L17. The column and, if necessary, the detector are maintained at a constant temperature of about 40
, and the flow rate is about 0.6 mL per minute. Chromatograph the
System suitability preparation, and measure the peak responses as directed for
Procedure: the resolution,
R, between the dextrose and xylitol peaks is not less than 2.5. Chromatograph the
Standard preparation as directed for
Procedure: the relative standard deviation for replicate injections is not more than 1.5% for dextrose.
Procedure—
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 dextrose peaks. Calculate the concentration, in g per 100 mL, of dextrose monohydrate (C
6H
12O
6·H
2O) in the volume of Injection taken by the formula:
(198.17 / 180.16)C(rU / rS),
in which
C is the concentration, in g per 100 mL, of
USP Dextrose RS in the
Standard preparation; and
rU and
rS are the peak areas obtained from the
Assay preparation and the
Standard preparation, respectively.
Assay for dextran 40—
To 25 mL of Injection add 1 drop of 5 N ammonium hydroxide, and mix. Determine the optical rotation (see
Optical Rotation 781), and calculate the concentration, in g per 100 mL, of Dextran 40 in the Injection taken by the formula:
(1 / 197.5)[(100
a /
l)
(52.75
Cd)],
in which 197.5 and 52.75 represent average values for the specific rotation of Dextran 40 and dextrose, respectively;
a is the observed optical rotation in degrees;
l is the length, in dm, of the polarimeter tube; and
Cd is the concentration, in g per 100 mL, of dextrose as determined in the
Assay for dextrose.
