DEFINITION

Technetium Tc 99m Oxidronate Injection is a sterile, clear, colorless solution, suitable for intravenous administration, of radioactive technetium (^99mTc) in the form of a chelate of oxidronate sodium. It contains NLT 90.0% and NMT 110.0% of the labeled amount of ^99mTc as chelate expressed in megabecquerels (microcuries or millicuries) per milliliter at the time indicated in the labeling. It may contain buffers, preservatives, reducing agents, and stabilizers. Other chemical forms of radioactivity are NMT 10.0% of the total radioactivity.