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. [note—Prior 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: in 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.

Expert Committee : (MDPS05) Monograph Development-Pulmonary and Steroids

USP31–NF26 Page 1927

Phone Number : 1-301-816-8143