Fructose Injection
»Fructose Injection is a sterile solution of Fructose in Water for Injection.It contains not less than 95.0percent and not more than 105.0percent of the labeled amount of fructose (C6H12O6).Fructose Injection contains no antimicrobial agents.
Packaging and storage— Preserve in single-dose containers,preferably of Type Ior Type IIglass.
Labeling— The label states the total osmolar concentration in mOsmol per L.Where the contents are less than 100mL,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—
Silver nitrate solution— Dissolve 0.6g of silver nitrate in 2.0mLof water in a 100-mLvolumetric flask,dilute with acetone to volume,and mix.
Sodium hydroxide solution— Dissolve 2.0g of sodium hydroxide in 5.0mLof water in a 100-mLvolumetric flask,dilute with alcohol to volume,and mix.
Alcoholic monobasic sodium phosphate— Dissolve 4.0g of monobasic sodium phosphate in 150mLof water,and add,with mixing,500mLof alcohol.Use the entire mixture,even if there are two phases.Prepare the solution fresh daily.
Standard preparation— Prepare an aqueous solution containing 2.5mg of USP Fructose RSper mL.
Test preparation— Dilute an accurately measured volume of Injection with water to obtain a solution having a known concentration of about 2.5mg 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 biphosphatefor 2.0minutes.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 105for 30minutes.Cool to room temperature,and apply 5µLeach of the Standard preparationand 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 30seconds,then spray with Sodium hydroxide solution:the RFvalue of the spot appearing within 3minutes from the Test preparationcorresponds to that obtained from the Standard preparation.
Bacterial endotoxins á85ñ— It contains not more than 0.5USP Endotoxin Unit per mL.
pHá791ñ: between 3.0and 6.0,determined on a portion to which 0.30mLof a saturated potassium chloride solution has been added for each 100mLand which previously has been diluted with water,if necessary,to a concentration of not more than 5%of fructose.
Heavy metals,Method Iá231ñ— Place a volume of Injection,equivalent to 4g of fructose,in a porcelain dish,and evaporate to a volume of about 10mL.Cool,and dilute with water to 25mL:the limit is 5ppm.
Limit of hydroxymethylfurfural— It meets the requirements of the test for Hydroxymethylfurfuralunder Fructose.
Other requirements— It meets the requirements under Injections á1ñ.
Assay— Transfer an accurately measured volume of Injection,equivalent to 5g of fructose,to a 100-mLvolumetric flask.Add 0.2mLof 6Nammonium hydroxide,dilute with water to volume,and mix.After 30minutes determine the angular rotation (see Optical Rotation á781ñ),and record the observed rotation,a,as an absolute number.Calculate the quantity,in mg,of fructose (C6H12O6)in each mLof the Injection taken by the formula:
1124a/lV,
in which lis the length,in dm,of the polarimeter tube;and Vis the volume,in mL,of Injection taken.
Auxiliary Information— Staff Liaison:Karen A Russo,Ph.D.,Scientist
Expert Committee:(PA1)Pharmaceutical Analysis 1
USP28–NF23Page 873
Phone Number:1-301-816-8379