Fast Method for the Determination of Residual Solvents in Radiopharmaceutical Products

Mihon, Mirela; Tuta, Catalin Stelian; Ion, Alina Catrinel; Niculae, Dana; Lavric, Vasile

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

Issue: 2017, Volume 68, Issue 4

Pages: 666-670

Publication date: 2017/5/15

https://doi.org/10.37358/RC.17.4.5526

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This article is published under the Creative Commons Attribution 4.0 International License

Citation Styles

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}
}

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