99mTc from kits

Technetium-99m radiopharmaceuticals manufactured from approved kits:

Technetium-99m radiopharmaceuticals are generally formulated from kits prepared in authorized manufacturing facilities. A cold kit contains the ligand to which 99mTc is to be complexed, an adequate quantity of reducing agent, buffer to adjust the pH to suit the labelling conditions, stabilizing agents and excipients. The kits are prepared in a freeze-dried form and have a long shelf life, ranging from several months to years, IEAE, Technecium-99m Radiopharmaceuticals: Manufacture of Kits.

* Determination of the content of ligand may be required by local regulations.

The principal tests for Technetium-99m tracers manufactured from kits are:

Test

Technique / instrument

Appearance / dissolution

Visual

Radioactivity, volumic activity

Dose calibrator

Radiochemical purity

Radio-TLC