Endotoxine Determination

For routine endotoxin determination, Elysia has selected the Endosafe NexGen system from Charles River Laboratories.

Endotoxin determination is an important part of quality control (QC) in a radiochemistry laboratory working with PET. During production, radiopharmaceuticals, such as FDG, are synthesized and administered intravenously to patients. Because these products are injected directly into the bloodstream, they must meet very strict requirements regarding sterility and safety. A key parameter in this quality control process is the analysis of endotoxins, which are pyrogenic components from the cell walls of gram-negative bacteria and can cause fever reactions in patients even if the product itself is sterile.

For this reason, endotoxin testing is routinely performed as a QC analysis for each batch of produced radiopharmaceutical. The analysis is typically carried out using the LAL method (Limulus Amebocyte Lysate), where endotoxins trigger an enzymatic reaction that is measured either colorimetrically or turbidimetrically. Modern systems, such as rapid cartridge-based instruments, make it possible to obtain quantitative results within approximately 10–15 minutes.