ARPANSA - Australian Radiation Protection and Nuclear Safety Agency

A Radiopharmaceutical Quality Assurance Test Program is conducted under a Memorandum of Understanding (MOU) between ARPANSA and the Therapeutic Goods Administration (TGA). As part of this MOU radiopharmaceuticals used in nuclear medicine in Australia are tested for compliance with specifications.

Radiopharmaceuticals are radioactive substances used in nuclear medicine for the diagnosis of disease or for therapy. They are obtained from the manufacturer as capsules, ready to inject preparations or in the form of “cold kits” containing non-radioactive components which are reconstituted by the addition of Sodium Pertechnetate [ ^99mTc] Injection.

Quality assurance of radiopharmaceuticals consists of physical quality control and general test procedures. For physical quality control, examination is performed to ascertain no leakage has occurred (a “wipe test” for external contamination). General test procedures include: appearance, radionuclidic purity, pH, radionuclidic content, radiochemical purity and labelling compliance. The analytical methods range from gamma spectrometry to paper chromatography, thin layer chromatography, electrophoresis (high and low), chemical analysis and high performance liquid chromatography.

General test procedures include:

1. Appearance
2. Radionuclidic purity
3. pH
4. Radionuclidic content
5. Radiochemical purity
   • paper chromatography
   • thin layer chromatography
   • electrophoresis (high or low voltage)
   • chemical or physical analysis
   • high performance liquid chromatography
6. Stannous tin content of [ ^99mTc] cold kits
7. Compliance of vial and package labels

The results of the Quality Assurance Program are published annually as technical reports.

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