Packaging and storage— Preserve in tight,single-dose containers,preferably of Type Ior Type IIglass,and store at controlled room temperature.

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

USP Reference standards á11ñ— USP Endotoxin RS.

Identification— It responds to the Identificationtests under Dextroseand under Dehydrated Alcohol.

Bacterial endotoxins á85ñ— It contains not more than 0.5USP Endotoxin Unit per mL.

pHá791ñ: between 3.5and 6.5,determined on a portion to which 0.30mLof saturated potassium chloride solution has been added for each 100mLand which previously has been diluted with water,if necessary,to a concentration of not more than 5%of dextrose.

Heavy metals á231ñ— Transfer a volume of Injection,equivalent to 4.0g of dextrose,to a vessel,and adjust the volume to 25mLby evaporation or by addition of water,as necessary:the limit is 0.0005C%,in which Cis the labeled amount,in g,of C6H12O6·H2Oper mLof Injection.

Limit of 5-hydroxymethylfurfural and related substances— Dilute an accurately measured volume of Injection,equivalent to 1.0g of C6H12O6·H2O,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.

Other requirements— It meets the requirements under Injections á1ñ.

Assay for alcohol— Determine by the Distillation Method á611ñ,using a 50.0-mLportion of Injection.

Assay for dextrose— Transfer an accurately measured volume of Injection,containing from 2g to 5g of dextrose,to a 100-mLvolumetric flask.Add 0.2mLof 6Nammonium hydroxide,dilute with water to volume,and mix.Determine the angular rotation in a 200-mm tube at 25(see Optical Rotation á781ñ).The observed rotation in degrees,multiplied by 1.0425,represents the weight,in g,of C6H12O6·H2Oin the volume of Injection taken.

Expert Committee:(PA2)Pharmaceutical Analysis 2

USP28–NF23Page 63

Phone Number:1-301-816-8139