Abstract
1116
Objectives Upon reviewing the Chemistry, Manufacturing and Controls (CMC) of imaging studies we frequently identify gaps in the quality control of radiopharmaceuticals and PET drugs.
Methods Analytical Chemistry is a critical tool in ensuring the identity and purity of radiopharmaceuticals, because these drugs are prepared in situ at the radiopharmacy as microdoses and administered to patients after brief purification. Quality Control (QC) is a crucial step prior to releasing the drug product for human administration, and QC requires good analytical chemistry practices. Yet, such practices are often overlooked in the QC of radiopharmaceuticals, for example, selecting a meaningful analytical method that provides adequate separation of the precursor and impurities from the product to reporting a meaningful quantitative result.
Results We present here examples of good and poor analytical chemistry practices, as applicable to PET radiopharmaceuticals containing Ga-68, F-18 and C-11 radionuclides. Good analytical chemistry practices can ensure that the drug product meets specifications that are consistent with a CMC plan.
Conclusions This will reasonably guarantee a safe product for human administration