DEFINITION

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 radioactive technetium (^99mTc). It is suitable for intravenous administration. It contains NLT 90.0% and NMT 110.0% of the labeled amount of ^99mTc as aggregated albumin expressed in megabecquerels (microcuries or millicuries) per milliliter at the time indicated in the labeling. Other chemical forms of radioactivity are NMT 10% of the total radioactivity. It may contain antimicrobial, reducing, chelating, and stabilizing agents, buffers, and nonaggregated albumin human. Its production and distribution are subject to federal regulations (see Radioactivity 〈821〉 and Biologics 〈1041〉).