» Technetium Tc 99m Nofetumomab Merpentan Injection is a sterile, nonpyrogenic preparation of the Fab fragment of IgG2b murine monoclonal antibody NR-LU-10 that is labeled with ^99mTc and is suitable for intravenous administration. It contains not less than 90.0 percent and not more than 110.0 percent of the labeled amount of ^99mTc as the nofetumomab complex, expressed in megabecquerels (or millicuries) per mL at the time indicated in the labeling. It may contain reducing agents, buffers, and stabilizers. It contains no antimicrobial agents. Other chemical forms of radioactivity do not exceed 10 percent of the total radioactivity. The immunoreactive fraction, as determined by a validated method, is not less than 85 percent.