» Indium In 111 Satumomab Pendetide Injection is a sterile, nonpyrogenic, virus-free preparation of monoclonal antibody B72.3 that is labeled with ¹¹¹In. Satumomab pendetide is prepared by site-specific conjugation of the linker-chelator, glycyl-tyrosyl-(N,E-diethylene triamine pentaacetic acid)-lysine hydrochloride to the oxidized oligosaccharide component of the monoclonal antibody B72.3. Satumomab pendetide is radiolabeled by the addition of a sterile, nonpyrogenic solution of a buffered Indium In 111 Chloride solution. It contains not less than 90.0 percent and not more than 110.0 percent of the labeled amount of ¹¹¹In as labeled satumomab pendetide expressed in megabecquerels (or in millicuries) per mL at the time indicated in the labeling. Other chemical forms of radioactivity do not exceed 10.0 percent of the total radioactivity. It may contain buffers and stabilizers. The immunoreactive fraction, as determined by a validated method, is not less than 60 percent.