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Influence of radiation on endotoxin test using the PTS TM for 18-FDG radiopharmaceutical / Influência da radiação sobre o teste de endotoxina usando o PTS TM para 18 radiofármaco FDG
Santos-Oliveira, Ralph.
  • Santos-Oliveira, Ralph; Nuclear Engineering Institute. Division of Radiopharmacy. BR
Braz. j. pharm. sci ; 46(3): 551-554, July-Sept. 2010. tab
Article in English | LILACS | ID: lil-564922
ABSTRACT
F-18 FDG (2-[18-F] fluoro-2-deoxy-D-glucose) is the most frequently used radiopharmaceutical for PET and PET CT imaging exams. The FDA recently approved the use of the PTS TM (Portable Test System) as an alternative to the standard test proposed by the United States Pharmacopeia using the LAL (Limulus Amebocyte Lysates), that takes longer to perform (about 1h) than the PTS TM (15 min). Recent studies have demonstrated that radiation could interfere with the PTS TM test. In order to study the effects of radiation on the PTS TM test and/or equipment, 27 batches of F-18 FDG produced in the Nuclear Engineering Institute were analyzed. The results showed that no direct correlation with radiation was found in any of the cases.
RESUMO
O FDG-18 é o radiofármaco mais utilizado nos exames de PET e PET CT. O FDA recentemente aprovou o uso do PTS TM (Portable Test System) como método alternativo ao teste padrão de endotoxina, proposto pela Farmacopéia Americana, considerando que no primeiro há um tempo de espera de 1 hora frente a somente 15 minutos do segundo. Estudo recentes demonstram que a radiação poderia interferir no teste do PTS TM. De modo a avaliar os efeitos da radiação no teste PTS TM foram analisados 27 lotes de F-18 FDG produzidos no Instituto de Engenharia Nuclear. Os resultados demonstraram que em todos os casos nenhuma correlação direta com a radiação foi observada.
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Full text: Available Index: LILACS (Americas) Main subject: Radiation / Research / Endotoxins Type of study: Evaluation studies Language: English Journal: Braz. j. pharm. sci Year: 2010 Type: Article Affiliation country: Brazil Institution/Affiliation country: Nuclear Engineering Institute/BR

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Full text: Available Index: LILACS (Americas) Main subject: Radiation / Research / Endotoxins Type of study: Evaluation studies Language: English Journal: Braz. j. pharm. sci Year: 2010 Type: Article Affiliation country: Brazil Institution/Affiliation country: Nuclear Engineering Institute/BR