» Technetium Tc 99m Arcitumomab Injection is a sterile, nonpyrogenic preparation of the 50,000-dalton Fab′ fragment generated from the murine IgG monoclonal antibody Immu-4, suitable for intravenous administration that is labeled with ^99mTc. It contains not less than 90.0 percent and not more than 110.0 percent of the labeled amount of ^99mTc as an arcitumomab complex, expressed in MBq (or mCi) per mL at the time indicated in the labeling. Other chemical forms of radioactivity do not exceed 10.0 percent of the total radioactivity. The immunoreactive fraction determined by a validated method is not less than 75%. The Fab′ fragment content is not less than 90 percent as determined by size-exclusion HPLC.