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 0.05.
Identification—
Dilute a portion of Injection quantitatively with sodium chloride solution (0.9 in 100) to a concentration of about 10 mg of Dextran 40 per mL. Using a capillary tube viscosimeter with a flow time for water of not less than 100 seconds, measure the flow times of the diluted Injection and of sodium chloride solution (0.9 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 sodium chloride solution;
t and
t0 are the flow times for the diluted Injection and the sodium chloride 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.
Assay for sodium chloride—
Pipet a volume of Injection, equivalent to about 90 mg of chloride, into a porcelain casserole, and add 100 mL of water and 1 mL of
dichlorofluorescein TS. Mix, and titrate with 0.1 N silver nitrate VS until the silver chloride flocculates and the mixture acquires a faint pink color. Each mL of 0.1 N silver nitrate is equivalent to 5.844 mg of sodium chloride.
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 volume of Injection taken by the formula:
100(a / l)(1 / 197.5),
in which 197.5 represents an average value for the specific rotation of dextran 40,
a is the observed optical rotation, in degrees, and
l is the length, in dm, of the polarimeter tube.
