Packaging and storage— Preserve in single-dose containers,preferably of Type Ior Type IIglass.

Labeling— The label states the total osmolar concentration in mOsmol per L.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.USP Fructose RS.

Identification— It responds to the Identificationtests under Fructose Injectionand to the tests for Sodium á191ñand for Chloride á191ñ.

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

pHá791ñ: between 3.0and 6.0.

Heavy metals,Method Iá231ñ— Proceed as directed in the test for Heavy metalsunder Fructose Injection:the limit is 5ppm.

Limit of hydroxymethylfurfural— It meets the requirements of the test for Hydroxymethylfurfuralunder Fructose.

Other requirements— It meets the requirements under Injections á1ñ.

Assay for fructose— Transfer an accurately measured volume of Injection,containing about 5g of fructose,to a 100-mLvolumetric flask,add 0.2mLof 6Nammonium hydroxide,dilute with water to volume,and mix.After 30minutes determine the angular rotation (see Optical Rotation á781ñ),and record the observed rotation,a,as an absolute number.Calculate the quantity,in mg,of fructose (C6H12O6)in each mLof the Injection taken by the formula: in which lis the length,in dm,of the polarimeter tube;and Vis the volume,in mL,of Injection taken.

Assay for sodium chloride— Transfer an accurately measured volume of Injection,equivalent to about 90mg of sodium chloride,to a conical flask,evaporate to a volume of about 10mL,and add 10mLof glacial acetic acid,75mLof methanol,and 0.5mLof eosin Y TS.Titrate,with shaking,with 0.1Nsilver nitrate VSto a pink endpoint.Each mLof 0.1Nsilver nitrate is equivalent to 5.844mg of sodium chloride (NaCl).

Expert Committee:(PA1)Pharmaceutical Analysis 1

USP28–NF23Page 874

Phone Number:1-301-816-8379