Packaging and storage— Preserve in single-dose glass or plastic containers.Glass containers are preferably of Type Ior Type IIglass.The container may be designed to empty rapidly and may contain a volume of more than 1liter.

Labeling— The designation “not for injection”appears prominently on the label.

USP Reference standards á11ñ— USP Endotoxin RS.

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

Sterility á71ñ: meets the requirements.

Other requirements— It responds to the Identificationtests,and meets the requirements for pH,Heavy metals,Assay for calcium,Assay for potassium,Assay for sodium,and Assay for chlorideunder Ringer's Injection.

Expert Committee:(PA1)Pharmaceutical Analysis 1

USP28–NF23Page 1740

Phone Number:1-301-816-8379