Cuban [18F]Fluorodeoxyglucose stability

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Lissett Gutiérrez Hernández
Yurilma González Valdés
Aily Caridad Aguiar Agramonte
Leonardo García Reyes
Henry Reyes Pérez
Wendy Delis Millares
Dianisleydis Gómez García
Hortensia Morales Arranz
Yordanka Martínez Almaguer
Mayka Guerrero Cancio

Abstract

The Specialized Center for Diagnosis and Therapy of the Center for Medical Surgical Research, produce [18F]FDG for using in medical imaging technology of Positron Emission Tomography in Cuba. The aim of this work was to evaluate the stability of the product at different time intervals under environmental conditions. [18F]FDG pH, radionuclidic identity and purity, chemical purity, residual solvents, bacterial endotoxins and sterility were evaluated. The results showed that Cuban [18F]FDG was stable in stored conditions, during twelve hours after delivering, between 22 and 25 °C of temperature.

Article Details

How to Cite
Gutiérrez Hernández, L., González Valdés, Y., Aguiar Agramonte, A. C., García Reyes, L., Reyes Pérez, H., Delis Millares, W., Gómez García, D., Morales Arranz, H., Martínez Almaguer, Y., & Guerrero Cancio, M. (2022). Cuban [18F]Fluorodeoxyglucose stability. Nucleus, (71), 40-44. Retrieved from http://nucleus.cubaenergia.cu/index.php/nucleus/article/view/761
Section
Ciencias Nucleares

References

[1]. United States Pharmacopeia. USP 40. Fludeoxyglucosa F 18 injection. The NF. 35 edition, 2017.
[2]. Centro para el Control Estatal de Medicamentos, Equipos y Dispositivos Médicos (CECMED). Directrices sobre Buenas prácticas de fabricación de productos farmacéuticos. Regulación No. 16-2012. La Habana: CECMED, 2012.
[3]. Centro para el Control Estatal de Medicamentos, Equipos y Dispositivos Médicos (CECMED). Requerimientos de los estudios de estabilidad para el registro de productos farmacéuticos nuevos y conocidos. Regulación No. 23-2000. La Habana: CECMED, 2000.
[4]. RAHMANI S, SHAHHOSEINI S, MOHAMADI R, VOJDANI M. Synthesis, quality control and stability studies of 2-[18F]Fluoro-2-Deoxy-D-Glucose(18F-FDG) at different conditions of temperature by physicochemical and microbiological assays. Iran J Pharm Res. 2017. 16 (2): 602-610.
[5]. European Medicines Agency (EMA). Science Medicines Health. ICH guideline Q3C (R6) on impurities: guideline for residual solvents. EMA/CHMP/ICH/82260/2006. Committee for Human Medicinal Products, 2018.
[6]. FERREIRA SZ, DA SILVA JB, WAQUIL SS AND CORREIA RF. Stability study of 2-[18F]Fluoruro-2-deoxy-D-glucose (18FDG) stored at room temperature by physicochemical and microbiological assays. International Nuclear Atlantic Conference - INAC. Rio de Janeiro, RJ, Brazil. September 27 -October 2, 2009. ISBN: 978-85-99141-03-8.

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