DEFINITION

Technetium Tc 99m Sulfur Colloid Injection is a sterile, colloidal dispersion of sulfur labeled with radioactive technetium (^99mTc), suitable for intravenous administration. It contains NLT 90.0% and NMT 110.0% of the labeled concentration of ^99mTc as sulfur colloid expressed in megabecquerels (microcuries or millicuries) per milliliter at the time indicated in the labeling. It may contain chelating agents, buffers, and stabilizing agents. Other chemical forms of radioactivity are NMT 8% of the total radioactivity.