Fructose and Sodium Chloride Injection
» Fructose and Sodium Chloride Injection is a sterile solution of Fructose and Sodium Chloride in Water for Injection. It contains not less than 95.0 percent and not more than 105.0 percent of the labeled amounts of C6H12O6 (fructose) and of NaCl (sodium chloride). Fructose and Sodium Chloride Injection contains no antimicrobial agents.
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.
Identification It responds to the Identification tests under Fructose Injection and to the tests for Sodium 191 and for Chloride 191.
Bacterial endotoxins 85 It contains not more than 0.5 USP Endotoxin Unit per mL.
pH 791: between 3.0 and 6.0.
Heavy metals, Method I 231 Proceed as directed in the test for Heavy metals under Fructose Injection: the limit is 5 ppm.
Limit of hydroxymethylfurfural It meets the requirements of the test for Hydroxymethylfurfural under Fructose.
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 (C6H12O6) in each mL of the Injection taken by the formula:
1124a / lVin 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).
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USP32NF27 Page 2456