What is the limit of endotoxin units for FDG quality control?

The limit of endotoxin units for FDG (fludeoxyglucose) quality control is indeed set at 175 USP endotoxin units per volume. This standard is crucial because endotoxins, which are components of the outer membrane of Gram-negative bacteria, can lead to severe adverse reactions in patients if present in significant amounts. The established limit ensures the safety and efficacy of the FDG used in PET imaging.

By adhering to this guideline, manufacturers can confirm the sterility of the FDG and mitigate potential health risks for patients receiving these radiopharmaceuticals. The 175 USP endotoxin units limit reflects a careful consideration of the potential toxicity of these substances and aligns with regulatory standards for injectable pharmaceuticals.