Packaging and storage— Preserve in single-dose containers,preferably of Type Iglass,protected from light.

USP Reference standards á11ñ— USP Endotoxin RS.

Bacterial endotoxins á85ñ— It contains not more than 0.9USP Endotoxin Unit per mg of iophendylate.

Other requirements— It conforms to the Definition,responds to the Identificationtest,and meets the requirements for Specific gravity,Refractive index,Residue on ignition,Free acids,Free iodine,Saponification value,and Assayunder Iophendylate.It meets also the requirements under Injections á1ñ.

Expert Committee:(RMI)Radiopharmaceuticals and Medical Imaging Agents

USP28–NF23Page 1048

Phone Number:1-301-816-8305