» Dextrose Injection is a sterile solution of Dextrose in Water for Injection. It contains not less than 95.0 percent and not more than 105.0 percent of the labeled amount of dextrose (C6H12O6·H2O). Dextrose Injection contains no antimicrobial agents.
Packaging and storage Preserve in single-dose glass or plastic containers. Glass containers are 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
Bacterial endotoxins 85 It contains not more than 0.5 USP Endotoxin Unit per mL for Injections containing less than 5% of dextrose and not more than 10.0 USP Endotoxin Units per g for Injections containing between 5% and 70% of dextrose. [notePrior to analysis, dilute Injections containing more than 10% of dextrose to a concentration of 10% of dextrose. ]
Identification It responds to the Identification test under Dextrose.
pH 791: between 3.2 and 6.5, determined on a portion to which 0.30 mL of 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 dextrose.
Particulate matter 788: meets the requirements.
Heavy metals 231 Transfer a volume of Injection, equivalent to 4.0 g of dextrose, to a suitable vessel, and adjust the volume to 25 mL by evaporation or addition of water, as necessary: the limit is 0.0005C%, in which C is the labeled amount, in g, of C6H12O6·H2O per mL of Injection.
Limit of 5-hydroxymethylfurfural and related substances Dilute an accurately measured volume of Injection, equivalent to 1.0 g of C6H12O6·H2O, with water to 250.0 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.
Other requirements It meets the requirements under Injections 1.
Assay Transfer an accurately measured volume of Injection, containing 2 to 5 g of dextrose, to a 100-mL volumetric flask. Add 0.2 mL of 6 N ammonium hydroxide, dilute with water to volume, and mix. Determine the angular rotation in a suitable polarimeter tube (see Optical Rotation 781). Calculate the percentage (g per 100 mL) of dextrose (C6H12O6·H2O) in the portion of Injection taken by the formula:
(100/52.9)(198.17/180.16)ARin which 100 is the percentage; 52.9 is the midpoint of the specific rotation range for anhydrous dextrose, in degrees; 198.17 and 180.16 are the molecular weights for dextrose monohydrate and anhydrous dextrose, respectively; A is 100 mm divided by the length of the polarimeter tube, in mm; and R is the observed rotation, in degrees.
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USP35NF30 Page 2862Pharmacopeial Forum: Volume No. 30(5) Page 1614