» Fructose Injection is a sterile solution of Fructose in Water for Injection. It contains not less than 95.0 percent and not more than 105.0 percent of the labeled amount of fructose (C6H12O6). Fructose 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.
USP Reference standards 11
USP Endotoxin RS
Silver nitrate solution Dissolve 0.6 g of silver nitrate in 2.0 mL of water in a 100-mL volumetric flask, dilute with acetone to volume, and mix.
Sodium hydroxide solution Dissolve 2.0 g of sodium hydroxide in 5.0 mL of water in a 100-mL volumetric flask, dilute with alcohol to volume, and mix.
Alcoholic monobasic sodium phosphate Dissolve 4.0 g of monobasic sodium phosphate in 150 mL of water, and add, with mixing, 500 mL of alcohol. Use the entire mixture, even if there are two phases. Prepare the solution fresh daily.
Standard preparation Prepare an aqueous solution containing 2.5 mg of USP Fructose RS per mL.
Test preparation Dilute an accurately measured volume of Injection with water to obtain a solution having a known concentration of about 2.5 mg of fructose per mL.
Procedure Immerse a suitable thin-layer chromatographic plate coated with a 0.25-mm layer of chromatographic silica gel, coated side down, in Alcoholic monobasic sodium biphosphate for 2.0 minutes. Remove the plate from the solution, place it, coated side up, on a clean, absorbent towel, dry it in a current of warm air, and activate it at 105 for 30 minutes. Cool to room temperature, and apply 5 µL each of the Standard preparation and the Test preparation. Allow the spots to dry, and develop the chromatogram in a solvent system consisting of a mixture of acetone, n-butyl alcohol, and water (50:40:10). Remove the plate, allow the solvent to evaporate, and spray the plate with Silver nitrate solution. Allow the plate to dry for 30 seconds, then spray with Sodium hydroxide solution: the RF value of the spot appearing within 3 minutes from the Test preparation corresponds to that obtained from the Standard preparation.
Bacterial endotoxins 85 It contains not more than 0.5 USP Endotoxin Unit per mL.
pH 791: between 3.0 and 6.0, determined on a portion to which 0.30 mL of a saturated potassium chloride solution has been added for each 100 mL and which previously has been diluted with water, if necessary, to a concentration of not more than 5% of fructose.
Heavy metals, Method I 231 Place a volume of Injection, equivalent to 4 g of fructose, in a porcelain dish, and evaporate to a volume of about 10 mL. Cool, and dilute with water to 25 mL: 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 Transfer an accurately measured volume of Injection, equivalent to 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.
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USP35NF30 Page 3288