» Technetium Tc 99m Albumin Aggregated Injection is a sterile, aqueous suspension of Albumin Human that has been denatured to produce aggregates of controlled particle size that are labeled with ^99mTc. It 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 aggregated albumin expressed in megabecquerels (microcuries or millicuries) per mL at the time indicated in the labeling. It may contain antimicrobial, reducing, chelating, and stabilizing agents, buffers, and nonaggregated albumin human. Other chemical forms of radioactivity do not exceed 10 percent of the total radioactivity. Its production and distribution are subject to federal regulations (see Biologics 〈1041〉 and Radioactivity 〈821〉 ).