Mirela Mihon, Catalin Stelian Tuta, Alina Catrinel Ion, Dana Niculae, Vasile Lavric
Fast Method for the Determination of Residual Solvents in Radiopharmaceutical Products
Abstract:
The aim of this work was the development and validation of a fast analytical method to determine the residual solvents content in radiopharmaceuticals such as: 18F-Fluorodeoxyglucose (18F-FDG), 18F-Fluoroestradiol (18F-FES), 18F-Fluorothymidine (18F-FLT),18F-Fluoromisonidazole (18F-FMISO). Radiopharmaceuticals are radioactive preparations for medical purposes used in nuclear medicine as tracers in diagnostic imaging and treatment of certain diseases. Positron Emission Tomography (PET) is a medical imaging technique that consists in introducing into the body of a small amount of a biologically active chemical compound labelled with a short lived positron-emitting radioisotope (18F, 11C, 68Ga). Residual solvents are critical impurities in radiopharmaceuticals that can affect labelling, stability and physicochemical properties of drugs. Therefore, the determination of these solvents is essential for quality control of radiopharmaceuticals. Validation of the control method for residual solvents by gas chromatography is referred by the European Pharmacopoeia using a special injection technique (head space). The parameters of the method, which comply with International Conference on Harmonization guidelines, are: accuracy, precision, linearity, limit of detection, limit of quantification and robustness. The proposed method (direct gas chromatography injection) proved to be linear, precise, accurate and robust. Good linearity was achieved for all the solvents and correlation coefficients (R2) for each residual solvent were found more than 0.99.
Keywords: residual solvent; ethanol; gas chromatography; radiopharmaceuticals; validation
Cite this article as: MIHON, M., TUTA, C.S., ION, A.C., NICULAE, D., LAVRIC, V., Fast Method for the Determination of Residual Solvents in Radiopharmaceutical Products, Rev. Chim., 68(4), 2017, 666-670.
Vancouver Mihon M, Tuta CS, Ion AC, Niculae D, Lavric V. Fast Method for the Determination of Residual Solvents in Radiopharmaceutical Products. Rev. Chim.[internet]. 2017 Apr;68(4):666-670. Available from: https://doi.org/10.37358/RC.17.4.5526
APA 6th edition Mihon, M., Tuta, C.S., Ion, A.C., Niculae, D. & Lavric, V. (2017). Fast Method for the Determination of Residual Solvents in Radiopharmaceutical Products. Revista de Chimie, 68(4), 666-670. https://doi.org/10.37358/RC.17.4.5526
Harvard Mihon, M., Tuta, C.S., Ion, A.C., Niculae, D., Lavric, V. (2017). 'Fast Method for the Determination of Residual Solvents in Radiopharmaceutical Products', Revista de Chimie, 68(4), pp. 666-670. https://doi.org/10.37358/RC.17.4.5526
IEEE M. Mihon, C.S. Tuta, A.C. Ion, D. Niculae, V. Lavric, "Fast Method for the Determination of Residual Solvents in Radiopharmaceutical Products". Revista de Chimie, vol. 68, no. 4, pp. 666-670, 2017. [online]. https://doi.org/10.37358/RC.17.4.5526
Text Mirela Mihon, Catalin Stelian Tuta, Alina Catrinel Ion, Dana Niculae, Vasile Lavric, Fast Method for the Determination of Residual Solvents in Radiopharmaceutical Products, Revista de Chimie, Volume 68, Issue 4, 2017, Pages 666-670, ISSN 2668-8212, https://doi.org/10.37358/RC.17.4.5526. (https://revistadechimie.ro/Articles.asp?ID=5526) Keywords: residual solvent; ethanol; gas chromatography; radiopharmaceuticals; validation
RIS TY - JOUR T1 - Fast Method for the Determination of Residual Solvents in Radiopharmaceutical Products A1 - Mihon, Mirela A2 - Tuta, Catalin Stelian A3 - Ion, Alina Catrinel A4 - Niculae, Dana A5 - Lavric, Vasile JF - Revista de Chimie JO - Rev. Chim. PB - Revista de Chimie SRL SN - 2668-8212 Y1 - 2017 VL - 68 IS - 4 SP - 666 EP - 670 UR - https://doi.org/10.37358/RC.17.4.5526 KW - residual solvent KW - ethanol KW - gas chromatography KW - radiopharmaceuticals KW - validation ER -
BibTex @article{RevCh2017P666, author = {Mihon Mirela and Tuta Catalin Stelian and Ion Alina Catrinel and Niculae Dana and Lavric Vasile}, title = {Fast Method for the Determination of Residual Solvents in Radiopharmaceutical Products}, journal = {Revista de Chimie}, volume = {68}, number = {4}, pages = {666-670}, year = {2017}, issn = {2668-8212}, doi = {https://doi.org/10.37358/RC.17.4.5526}, url = {https://revistadechimie.ro/Articles.asp?ID=5526} }
