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 95.0 percent and not more than 105.0 percent 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 I or Type II glass, or of a suitable plastic material.
Labeling— The label states the total osmolar concentration in mOsmol per L.
USP Reference standards 11
USP Endotoxin RS
Identification— Add a few drops of Injection to 5 mL of hot alkaline cupric tartrate TS: a copious red precipitate of cupric oxide is formed.
Bacterial endotoxins 85 It contains not more than 0.5 USP Endotoxin Unit per mL.
pH 791: between 3.0 and 6.5.
Chloride 221 A 2.0-mL portion shows no more chloride than corresponds to 0.34 mL of 0.020 N hydrochloric acid (0.012%).
Heavy metals 231 Transfer a volume of Injection, equivalent to 4.0 g of invert sugar, to a suitable vessel, and adjust the volume to 25 mL by evaporation: the limit is 0.0005C%, in which C is the labeled amount, in g, of invert sugar per mL of Injection.
Limit of 5-hydroxymethylfurfural and related substances— Dilute an accurately measured volume of Injection, equivalent to 1.0 g of invert sugar, with water to 500.0 mL. Determine the absorbance of this solution in a 1-cm cell at 284 nm, 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 0.25 mg of sucrose and about 12.5 mg of dextrose per mL.
Test preparation— Transfer a volume of Injection, equivalent to about 2.5 g of invert sugar, to a 100-mL volumetric flask, dilute with water to volume, and mix.
Chromatographic system (see Chromatography 621)—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 20 µL) of the Standard preparation and the Test preparation into 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 C is the concentration, in mg per mL, of sucrose in the Standard preparation, and rU and rS are the peak responses for sucrose obtained from the Test preparation and 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 1.
Assay— Pipet 50 mL of alkaline cupric tartrate TS into a 400-mL beaker, add 48 mL of water, mix, and pipet into the mixture 2 mL of 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 4 minutes, and continue boiling for 2.0 minutes. Filter the hot solution at once through a tared porcelain filtering crucible, wash the precipitate with water maintained at 60, then with 10 mL of alcohol. Dry at 105 to constant weight. Perform a blank determination, and make any necessary correction. The corrected weight of the precipitate so obtained is not less than 204.0 mg and not more than 224.4 mg, corresponding to between 95.0 and 105.0 mg of C6H12O6.
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Topic/Question Contact Expert Committee
Monograph Mary S. Waddell
Scientific Liaison
(SM42010) Monographs - Small Molecules 4
Reference Standards RS Technical Services
85 Radhakrishna S Tirumalai, Ph.D.
Principal Scientific Liaison
(GCM2010) General Chapters - Microbiology
USP35–NF30 Page 4698