Packaging and storage— Preserve in single-dose glass or plastic containers.Glass containers are preferably of Type Ior Type IIglass.

Labeling— The label states the total osmolar concentration in mOsmol per liter.Where the contents are less than 100mL,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 á11ñ— USP Endotoxin RS.

Bacterial endotoxins á85ñ— It contains not more than 0.5USP Endotoxin Unit per mLfor Injections containing less than 5%of dextrose and not more than 10.0USP 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 Identificationtest under Dextrose.

pHá791ñ: between 3.2and 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.

Particulate matter á788ñ: meets the requirements.

Heavy metals á231ñ— Transfer a volume of Injection,equivalent to 4.0g of dextrose,to a suitable vessel,and adjust the volume to 25mLby evaporation or 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 250.0mL.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— Transfer an accurately measured volume of Injection,containing 2to 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 suitable polarimeter tube at 25(see Optical Rotation á781ñ).The observed rotation,in degrees,multiplied by 1.0425A,in which Ais the ratio 200divided by the length,in mm,of the polarimeter tube employed,represents the weight,in g,of C6H12O6·H2Oin the volume of Injection taken.

Expert Committee:(PA1)Pharmaceutical Analysis 1

USP28–NF23Page 612

Phone Number:1-301-816-8379