Technetium Tc 99m Oxidronate Injection, chemical structure, molecular formula, Reference Standards

Technetium Tc 99m Oxidronate Injection

»Technetium Tc 99m Oxidronate Injection is a sterile,clear,colorless solution,suitable for intravenous administration,of radioactive technetium (99mTc)in the form of a chelate of oxidronate sodium.It contains not less than 90.0percent and not more than 110.0percent of the labeled amount of 99mTc as chelate expressed in megabecquerels (microcuries or millicuries)per mLat the time indicated in the labeling.It may contain buffers,preservatives,reducing agents,and stabilizers.Other chemical forms of radioactivity do not exceed 10.0percent of the total radioactivity.

Packaging and storage— Preserve in single-dose or multiple-dose containers.

Labeling— Label it to include the following,in addition to the information specified for Labelingunder Injections á1ñ:the time and date of calibration;the amount of 99mTc as labeled oxidronate expressed as total megabecquerels (microcuries or millicuries)and concentration as megabecquerels (microcuries or millicuries)per mLat the time of calibration;the expiration date and time;and the statement “Caution—Radioactive Material.”The labeling indicates that in making dosage calculations,correction is to be made for radioactive decay,and also indicates that the radioactive half-life of 99mTc is 6.0hours.

USP Reference standards á11ñ— USP Endotoxin RS.

pHá791ñ: between 2.5and 7.0.

Other requirements— It meets the requirements for Bacterial endotoxins,Radiochemical purity,Biological distribution,Other requirements,and Assay for radioactivityunder Technetium Tc 99m Pyrophosphate Injection.

Auxiliary Information— Staff Liaison:Andrzej Wilk,Ph.D.,Senior Scientific Associate

Expert Committee:(RMI)Radiopharmaceuticals and Medical Imaging Agents

USP28–NF23Page 1860

Phone Number:1-301-816-8305