Publicação
Optimization and validation of [13N]-NH3 production for clinical studies of positron emission tomography in the evaluation of myocardial perfusion
| Resumo: | The present work aims to validate the [ 13 N]-NH 3 production for human studies of myocardial perfusion using a cyclotron from a Portuguese public institution and an automatic synthesis module. According to specifications of European Pharmacopeia (Ph. Eur.) 8.2., 3 consecutives batches were evaluated for this purpose. Results showed a clear and colorless product and pH values between 4,5 e 8,5. The chemical purity was confirmed by the colorimetric test and the samples were identified as [ 13 N]-NH 3 , by ionic chromatography, gamma ray spectroscopy and half-life determination. Radiochemical and radionuclidic purity were confirmed, corresponding a minimum of 99% of total radioactivity to [ 13 N] and a percentage of impurities less than 1%, 2 hours after the end of synthesis. Tests for sterility and for presence of bacterial endotoxins were also performed. |
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| Autores principais: | Serra, Cristina |
| Outros Autores: | Neves, Angela; Abrunhosa, Antero J.; Metello, Luis F. |
| Assunto: | Myocardial Perfusion Positron emission tomography PET |
| Ano: | 2015 |
| País: | Portugal |
| Tipo de documento: | documento de conferência |
| Tipo de acesso: | acesso restrito |
| Instituição associada: | Instituto Politécnico do Porto |
| Idioma: | inglês |
| Origem: | Repositório Científico do Instituto Politécnico do Porto |
| Resumo: | The present work aims to validate the [ 13 N]-NH 3 production for human studies of myocardial perfusion using a cyclotron from a Portuguese public institution and an automatic synthesis module. According to specifications of European Pharmacopeia (Ph. Eur.) 8.2., 3 consecutives batches were evaluated for this purpose. Results showed a clear and colorless product and pH values between 4,5 e 8,5. The chemical purity was confirmed by the colorimetric test and the samples were identified as [ 13 N]-NH 3 , by ionic chromatography, gamma ray spectroscopy and half-life determination. Radiochemical and radionuclidic purity were confirmed, corresponding a minimum of 99% of total radioactivity to [ 13 N] and a percentage of impurities less than 1%, 2 hours after the end of synthesis. Tests for sterility and for presence of bacterial endotoxins were also performed. |
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