Radiopharmaceuticals Quality Control

The Radiochemical Studies Laboratory has been authorized by the National Drug Organization (EOF) for the Quality Control of all radiopharmaceuticals on the Greek market, whether they are imported from abroad or produced in the country. Also, utilizing its know-how and its facilities, the Laboratory provides services to third parties and mainly to Pharmaceutical Industries, by performing specialized analyses of conventional drugs, many of which require the use of radioactive reagents, specialized facilities and qualified personnel.

The Laboratory determines the radioisotopic and radiochemical suitability of radiolabeled preparations intended for clinical application, as defined by the current National and European Legislation. Also, biodistribution in normal rodents is examined, while at the same time sterility and the absence of pyrogenic substances in these preparations are assessed.

Among the new services provided by the Laboratory is the QC of new Gallium-68 radiopharmaceuticals, such as ⁶⁸Ga-DOTATATE and ⁶⁸Ga-PSMA, prepared in Nuclear Medicine departments of some hospitals (“in-house” preparation of radiopharmaceuticals). These innovative diagnostic radiopharmaceuticals contribute to detailed disease staging, as well as to the assessment of the therapeutic effect of the applied therapy.

In the context of the services provided by the Laboratory, the following analyses are performed:

1. Determination of radioisotopic purity
2. Determination of radiochemical purity
3. Particle size determination and percent determination of colloidal or agglomerated species
4. Sterility control of injectable solutions
5. Test for the presence of bacterial endotoxins (pyrogens) in injectable solutions
6. Biodistribution studies

All tests are performed in accordance with the European Pharmacopoeia Monographs (European Pharmacopoeia 9.0), the World Health Organization (WHO) Monographs for Individual Radiopharmaceuticals (WHO) and the Package Leaflets for each radiopharmaceutical.