What is the required limit of hydrolysis step for CLDG according to FDG QC?

The correct answer is that the required limit of the hydrolysis step for carbon-11 labeled glucose (CLDG) according to FDG quality control (QC) is less than 1 mg per administered dose.

This limit is crucial for ensuring the safety and efficacy of the radiopharmaceutical used in positron emission tomography (PET) imaging. Hydrolysis of CLDG can lead to the accumulation of free fluoride ion (F-) and other degradation products, which may not only reduce the quality of the imaging agent but could also introduce safety concerns if administered in excess. By maintaining the hydrolysis products below this threshold, the radiopharmaceutical can provide accurate imaging while minimizing any potential pharmacological issues associated with higher amounts of these constituents.

Maintaining the limit of less than 1 mg ensures that the administered dose remains within the acceptable regulatory and clinical guidelines, thus preserving patient safety and the integrity of the PET imaging procedure.