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

USP Reference standards 11— USP Endotoxin RS.

Bacterial endotoxins 85— It contains not more than 0.9 USP Endotoxin Unit per mg of iophendylate.

Residual solvents 467: meets the requirements.

Other requirements— It conforms to the Definition, responds to the Identification test, and meets the requirements for Specific gravity, Refractive index, Residue on ignition, Free acids, Free iodine, Saponification value, and Assay under Iophendylate. It meets also the requirements under Injections 1.

Expert Committee : (RMI05) Radiopharmaceuticals and Medical Imaging Agents 05

USP29–NF24 Page 1163

Phone Number : 1-301-816-8305