» Indium In 111 Capromab Pendetide Injection is a sterile, nonpyrogenic, murine monoclonal antibody, 7E11-C 5.3, (CYT-351), an immunoconjugate prepared by specific modification of the carbohydrate groups and covalent binding to the tripeptide linker chelator, glycyltyrosyl-(N, E-diethylenetriaminepentaacetic acid)-lysine hydrochloride that is complexed with ¹¹¹In. It contains not less than 90.0 percent and not more than 110.0 percent of the specified amount of ¹¹¹In capromab pendetide, expressed in megabexquerels (or 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. Immediately prior to use, the radiolabeling is performed with Indium In 111 Chloride Solution in the presence of a sodium acetate buffer. It contains sodium chloride and buffering agents as stabilizers. The immuno-reactive fraction, determined by a validated method, is not less than 70 percent. The monomer content is not less than 95 percent determined by a validated electrophoretic mobility method.