DEFINITION

Technetium Tc 99m Exametazime Injection is a sterile, aqueous solution, suitable for intravenous administration, composed of the primary lipophilic complex of exametazime that is labeled with radioactive technetium (^99mTc). It contains NLT 90.0% and NMT 110.0% of the labeled amount of ^99mTc as primary lipophilic exametazime complex expressed in megabecquerels (microcuries or millicuries) per milliliter at the date and time indicated in the labeling. Other chemical forms of radioactivity (^99mTc pertechnetate, ^99mTc hydrolyzed reduced species, and ^99mTc secondary exametazime complex) are NMT 20.0% of the total radioactivity. It may contain antioxidants, reducing agents, and buffers. A stabilizing solution may be added to the final radiolabeled product.