» Iodinated I 131 Albumin Aggregated Injection is a sterile aqueous suspension of Albumin Human that has been iodinated with 131I and denatured to produce aggregates of controlled particle size. Each mL of the suspension contains not less than 300 µg and not more than 3.0 mg of aggregated albumin with a specific activity of not less than 7.4 megabecquerels (200 microcuries) per mg and not more than 44.4 megabecquerels (1.2 millicuries) per mg of aggregated albumin. Iodinated I 131 Albumin Aggregated Injection contains not less than 95.0 percent and not more than 105.0 percent of the labeled amount of 131I, as aggregated albumin, expressed in megabecquerels (microcuries) per mL or megabecquerels (millicuries) per mL at the time indicated in the labeling. Other chemical forms of radioactivity do not exceed 6 percent of the total radioactivity. Its production and distribution are subject to federal regulations (see Biologics 〈1041〉 and Radioactivity 〈821〉).
