Invert Sugar Injection
»Invert Sugar Injection is a sterile solution of a mixture of equal amounts of Dextrose and Fructose in Water for Injection,or an equivalent sterile solution produced by the hydrolysis of Sucrose,in Water for Injection.It contains not less than 95.0percent and not more than 105.0percent of the labeled amount of C6H12O6.It contains no antimicrobial agents.
NOTE—Invert Sugar Injection that is produced by mixing Dextrose and Fructose is exempt from the requirement of the test for Completeness of inversion.
Packaging and storage— Preserve in single-dose containers,preferably of Type Ior Type IIglass,or of a suitable plastic material.
Labeling— The label states the total osmolar concentration in mOsmol per liter.
Identification— Add a few drops of Injection to 5mLof hot alkaline cupric tartrate TS:a copious red precipitate of cupric oxide is formed.
Bacterial endotoxins á85ñ— It contains not more than 0.5USP Endotoxin Unit per mL.
pHá791ñ: between 3.0and 6.5.
Chloride á221ñ— A2.0-mLportion shows no more chloride than corresponds to 0.34mLof 0.020Nhydrochloric acid (0.012%).
Heavy metals á231ñ— Transfer a volume of Injection,equivalent to 4.0g of invert sugar,to a suitable vessel,and adjust the volume to 25mLby evaporation:the limit is 0.0005C%,in which Cis the labeled amount,in g,of invert sugar per mLof Injection.
Limit of 5-hydroxymethylfurfural and related substances— Dilute an accurately measured volume of Injection,equivalent to 1.0g of invert sugar,with water to 500.0mL.Determine the absorbance of this solution in a 1-cm cell at 284nm,with a suitable spectrophotometer,using water as the blank:the absorbance is not more than 0.25.
Completeness of inversion—
Mobile phase— Use filtered,degassed water.
Standard preparation— Prepare a solution in water containing known concentrations of about 0.25mg of sucrose and about 12.5mg of dextrose per mL.
Test preparation— Transfer a volume of Injection,equivalent to about 2.5g of invert sugar,to a 100-mLvolumetric flask,dilute with water to volume,and mix.
Chromatographic system (see Chromatography á621ñ)—The liquid chromatograph is equipped with a refractive index detector and a 7.8-mm ×30-cm column that contains 9-µm packing L19,maintained at a constant temperature of about 40.Chromatograph the Standard preparation,and record the peak responses as directed for Procedure:the sucrose elutes first,and the peak is baseline separated from the dextrose peak.The relative standard deviation for replicate injections is not more than 2.0%.
Procedure— Separately inject equal volumes (about 20µL)of the Standard preparationand the Test preparationinto the chromatograph,record the chromatograms,and measure the responses for the sucrose peaks.Calculate the quantity,in mg,of sucrose,in the volume of the Injection taken by the formula:
100C(rU/rS),
in which Cis the concentration,in mg per mL,of sucrose in the Standard preparation,and rUand rSare the peak responses for sucrose obtained from the Test preparationand the Standard preparation,respectively:not more than 1.5%of the quantity of invert sugar in the volume of Injection taken,based on the value stated on the label,is found.
Other requirements— It meets the requirements under Injections á1ñ.
Assay— Pipet 50mLof alkaline cupric tartrate TSinto a 400-mLbeaker,add 48mLof water,mix,and pipet into the mixture 2mLof Injection that has been diluted quantitatively with water,if necessary,to a 5.0%concentration.Cover the beaker with a watch glass,heat the solution,regulating the heat so that boiling begins in 4minutes,and continue boiling for 2.0minutes.Filter the hot solution at once through a tared porcelain filtering crucible,wash the precipitate with water maintained at 60,then with 10mLof alcohol.Dry at 105to constant weight.Perform a blank determination,and make any necessary correction.The corrected weight of the precipitate so obtained is not less than 204.0mg and not more than 224.4mg,corresponding to between 95.0and 105.0mg of C6H12O6.
Auxiliary Information— Staff Liaison:Karen A Russo,Ph.D.,Scientist
Expert Committee:(PA1)Pharmaceutical Analysis 1
USP28–NF23Page 1812
Phone Number:1-301-816-8379