Packaging and storage— Preserve in tight, single-dose containers, preferably of Type I or Type II glass, and store at controlled room temperature.

Labeling— The label states the total osmolarity of the solution expressed in mOsmol per L.

USP Reference standards 11— USP Endotoxin RS.

Identification— It responds to the Identification tests under Dextrose and under Dehydrated Alcohol.

Bacterial endotoxins 85— It contains not more than 0.5 USP Endotoxin Unit per mL.

pH 791: between 3.5 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.

Heavy metals 231— Transfer a volume of Injection, equivalent to 4.0 g of dextrose, to a vessel, and adjust the volume to 25 mL by evaporation or by 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 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.

Residual solvents 467: meets the requirements.

Other requirements— It meets the requirements under Injections 1.

Assay for alcohol— Determine by Method I—Distillation Method under Alcohol Determination 611, using a 50.0-mL portion of Injection.

Assay for dextrose— Transfer an accurately measured volume of Injection, containing from 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 : (MDCCA05) Monograph Development-Cough Cold and Analgesics

USP29–NF24 Page 70

Phone Number : 1-301-816-8139