» Technetium Tc 99m Albumin Colloid Injection is a sterile, pyrogen-free, aqueous suspension of Albumin Human that has been denatured to produce colloids of controlled particle size and that are 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 albumin colloid complex, expressed in megabecquerels (millicuries) per mL at the time indicated on the labeling. Other chemical forms of radioactivity do not exceed 10.0 percent of the total radioactivity. It may contain suitable reducing agents, buffers, stabilizers, and nonaggregated albumin human. The vials are sealed under a suitable inert atmosphere. Its production and distribution are subject to federal regulations (see Biologics 〈1041〉 and Radioactivity 〈821〉).