Packaging and storage—
Preserve in single-dose containers, preferably of Type I or Type II glass.
Labeling—
The label states the total osmolar concentration in mOsmol per L. Where the contents are less than 100 mL, or where the label states that the Injection is not for direct injection but is to be diluted before use, the label alternatively may state the total osmolar concentration in mOsmol per mL.
Other requirements—
It meets the requirements under
Injections 
1
.
Assay for fructose—
Transfer an accurately measured volume of Injection, containing about 5 g of fructose, to a 100-mL volumetric flask, add 0.2 mL of 6 N ammonium hydroxide, dilute with water to volume, and mix. After 30 minutes determine the angular rotation (see
Optical Rotation 781), and record the observed rotation,
a, as an absolute number. Calculate the quantity, in mg, of fructose (C
6H
12O
6) in each mL of the Injection taken by the formula:
1124a / lV,
in which
l is the length, in dm, of the polarimeter tube; and
V is the volume, in mL, of Injection taken.
Assay for sodium chloride—
Transfer an accurately measured volume of Injection, equivalent to about 90 mg of sodium chloride, to a conical flask, evaporate to a volume of about 10 mL, and add 10 mL of glacial acetic acid, 75 mL of methanol, and 0.5 mL of
eosin Y TS. Titrate, with shaking, with 0.1 N silver nitrate VS to a pink endpoint. Each mL of 0.1 N silver nitrate is equivalent to 5.844 mg of sodium chloride (NaCl).
