APPLICATION OF THE ENDOZYME® II ASSAY RANGE FOR RADIOPHARMACEUTICALS

According to Directive CEE 89/343, a radiopharmaceutical is defined as any medicinal product that contains one or more radionuclides (radioactive isotopes) intended for a medicinal purpose. These compounds play a crucial role in both diagnostic and therapeutic procedures and can be used alone or conjugated with drugs or peptide molecules. Radiopharmaceuticals are subject to stringent regulations and quality control measures to ensure their safety and efficacy.

The European Pharmacopoeia (Ph. Eur.) provides guidelines for the production and testing of these compounds through specific monographs. The general monograph Ph. Eur. 0125 (Radiopharmaceutical Preparations) has been updated to include Chapter 5.1.13 on pyrogenicity. This chapter allows testing of new radiopharmaceutical preparations (in the absence of a specific product monograph) for endotoxins using either the Limulus Amebocyte Lysate (LAL) test or the recombinant Factor C (rFC) method.

rFC offers a sustainable, biotechnology-based alternative to the animal-derived LAL test and was included in the European Pharmacopoeia in early 2021 (1). An additional advancement was the inclusion of rFC as Method G in Chapter 2.6.14 (2). This update is now in place, and the finalization of this implementation is expected by July 2026.

In this technical note, we demonstrate the applicability and advantages of the rapid and flexible rFC-based method ENDOZYME® II GO Strips for the commonly used fluorine-18 (18F) labeled radiopharmaceuticals: [18F] Fluorodeoxyglucose ([18F]FDG) and ProstateSpecific Membrane Antigen ([18F]PSMA).