Validation of new gas chromatography-flame ionization detection procedure for quantitation of residual solvents in [18F]FDG

Autores/as

  • Flávia Mesquita Costa Serviço de Radiofármacos – SERAF, Centro de Desenvolvimento da Tecnologia Nuclear - CDTN/CNEN, Belo Horizonte - MG.
  • Cassiano Lino dos Santos Costa Serviço de Radiofármacos – SERAF, Centro de Desenvolvimento da Tecnologia Nuclear - CDTN/CNEN, Belo Horizonte - MG.
  • Juliana Batista Silva Serviço de Radiofármacos – SERAF, Centro de Desenvolvimento da Tecnologia Nuclear - CDTN/CNEN, Belo Horizonte - MG.
  • Soraya Maria Zandim Maciel Dias Ferreira Serviço de Radiofármacos – SERAF, Centro de Desenvolvimento da Tecnologia Nuclear - CDTN/CNEN, Belo Horizonte - MG.

DOI:

https://doi.org/10.15392/bjrs.v7i2A.642

Palabras clave:

Fludeoxyglucose, GC-FID, Method validation, Organic solvents.

Resumen

Fludeoxyglucose F 18 ([18F]FDG) is the most used radiopharmaceutical for positron emission tomography, especially on oncology. Organic solvents such as ether, ethanol and acetonitrile might be used in the synthesis of [18F]FDG; however, they might not be completely removed during purification steps. The determination of residual solvents in [18F]FDG is required in the European Pharmacopoeia (EP) and the United States Pharmacopeia (USP) monographs. While the procedure described in the EP is quite general, the one described in the USP requires a long runtime (about 13 minutes). In this work a simple and fast (4-minute) analytical procedure was developed and validated for determination of residual solvents in [18F]FDG. Analyses were carried out by gas chromatography – flame ionization detector (GC-FID). The separation was obtained on a 0.53-mm x 30 m fused-silica column. Validation included the evaluation of various parameters, such as: specificity, linearity and range, limits of detection and quantitation, precision (repeatability and intermediate precision), accuracy, and robustness. Results were found to be within acceptable limits, indicating the developed procedure is suitable for its intended application. Considering the short half-life of fluorine-18 (109.7 minutes), this new method could be a valuable alternative for routine quality control of [18F]FDG.

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Referencias

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Publicado

2019-02-19

Número

Vol. 7 Núm. 2A (Suppl.) (2019): ENAN 2017

Sección

The Meeting on Nuclear Applications (ENAN)

Licencia

Derechos de autor 2021 Brazilian Journal of Radiation Sciences (BJRS)

Creative Commons License

Esta obra está bajo una licencia internacional Creative Commons Atribución 4.0.

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Cómo citar

Validation of new gas chromatography-flame ionization detection procedure for quantitation of residual solvents in [18F]FDG. Brazilian Journal of Radiation Sciences (BJRS), Rio de Janeiro, Brazil, v. 7, n. 2A (Suppl.), 2019. DOI: 10.15392/bjrs.v7i2A.642. Disponível em: https://bjrs.org.br/revista/index.php/REVISTA/article/view/642. Acesso em: 16 jul. 2025.