Influence of radiation on endotoxin test using the PTSTM for 18-FDG radiopharmaceutical



Document title: Influence of radiation on endotoxin test using the PTSTM for 18-FDG radiopharmaceutical
Journal: Brazilian journal of pharmaceutical sciences
Database: PERIÓDICA
System number: 000333590
ISSN: 1984-8250
Authors: 1
Institutions: 1Instituto de Energia Nuclear, Divisao de Radiofarmacia, Rio de Janeiro. Brasil
Year:
Season: Jul-Sep
Volumen: 46
Number: 3
Pages: 551-554
Country: Brasil
Language: Inglés
Document type: Artículo
Approach: Experimental, aplicado
English 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 PTSTM (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 PTSTM (15 min). Recent studies have demonstrated that radiation could interfere with the PTSTM test. In order to study the effects of radiation on the PTSTM 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
Portuguese abstract O FDG-18 é o radiofármaco mais utilizado nos exames de PET e PET CT. O FDA recentemente aprovou o uso do PTSTM (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 PTSTM. De modo a avaliar os efeitos da radiação no teste PTSTM 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
Disciplines: Química,
Medicina
Keyword: Química farmacéutica,
Medicina nuclear,
Tomografía por emisión de positrones,
Radiofármacos,
Prueba de endotoxina
Keyword: Chemistry,
Medicine,
Medicinal chemistry,
Nuclear medicine,
Positron emission tomography,
Radiopharmaceuticals,
Endotoxin test
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