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.

Identification— It responds to the tests for Sodium á191ñand for Chloride á191ñ.

Bacterial endotoxins á85ñ— It contains not more than 0.5USP Endotoxin Unit per mLwhere the labeled amount of sodium chloride in the Injection is between 0.5%and 0.9%,and not more than 3.6USP Endotoxin Units per mLwhere the labeled amount of sodium chloride in the Injection is between 3.0%and 24.3%.

pHá791ñ: between 4.5and 7.0.

Particulate matter á788ñ: meets the requirements.

Iron á241ñ— Dilute 5.0mLof Injection with water to 45mL,and add 2mLof hydrochloric acid:the limit is 2ppm.

Heavy metals,Method Iá231ñ— Place a volume of Injection,equivalent to 1.0g of sodium chloride,in a suitable vessel,if necessary evaporate to a volume of about 20mL,add 2mLof 1Nacetic acid,then dilute with water to 25mL.Proceed as directed,except to use 1mLof Standard Lead Solution(10µg of Pb)in the Standard Preparationand in the Monitor Preparation:the limit is 0.001%,based on the amount of sodium chloride.

Other requirements— It meets the requirements under Injections á1ñ.

Assay— Pipet a volume of Injection,equivalent to about 90mg of sodium chloride,into a conical flask.Add water,if necessary,to bring the volume to about 10mL,and add 10mLof glacial acetic acid,75mLof methanol,and 3drops of 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 NaCl.

Expert Committee:(PA1)Pharmaceutical Analysis 1

USP28–NF23Page 1780

Phone Number:1-301-816-8379