title: Comparison of Limulus amebocyte lysates with the United States pharmacopeial pyrogen test and the portable test system for radiopharmaceuticals.
abstract: Radiopharmaceuticals play an important role in modern nuclear medicine, and 18F-FDG (2-[18F] fluoro-2-deoxy-D-glucose) is the most frequently used in imaging examinations today. The pyrogen test represents an important parameter for the quality of radiopharmaceuticals since most of them, 18F-FDG included, are injectable solutions. However, the standard test proposed by the U.S. Pharmacopeia using limulus amebocyte lysates takes too long (about 1 h). An alternative test is the Portable Test System, which takes no more than 15 min. In order to compare both tests, 10 batches of 18F-FDG produced in the Nuclear Engineering Institute, Rio de Janeiro, Brazil, were analyzed. The results showed that in 40% of the samples analyzed, different results were found. From the total analyzed, 20% showed totally diverging results, and 80% demonstrated partial similarity. These differences have a great impact in the choice of the test used for radiopharmaceutical injectable solutions and the importance of validation tests before the implementation in the daily routine.
authors.affiliation: Nuclear Engineering Institute, Radiopharmaceutical Division, Rua Hélio de Almeida No. 75, Ilha do Fundao, Rio de Janeiro, 21.941-906, Brazil. roliveira@ien.gov.br
authors.forename: Ralph
authors.initials: R
authors.lastname: Santos-Oliveira
mesh_terms: D019788:Fluorodeoxyglucose F18 / Q000592:standards*; D008033:Limulus Test; D010602:Pharmacopoeias as Topic; D011749:Pyrogens / Q000032:analysis*; D019275:Radiopharmaceuticals / Q000592:standards*
chemical_list: D011749:Pyrogens; D019275:Radiopharmaceuticals; D019788:Fluorodeoxyglucose F18