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https://hdl.handle.net/11499/46160
Title: | Validation of Hplc Method for the Determination of Chemical and Radiochemical Purity of a 68ga-Labelled Euk-Sub Dotaga | Authors: | Uğur, A. Elçi, Ş.G. Yüksel, D. |
Keywords: | Imaging Agents Quality Control Radio-Hplc Radiochemical Purity Radiolabeling |
Publisher: | TUBITAK | Abstract: | The prostate-specific membrane antigen (PSMA) represents an ideal biomarker for molecular imaging. Various PSMA-targeted radioligands are available for prostate cancer imaging. In this study, labeling of PSMA I&T with 68Ga, as well as validation of the radiochemical purity of the synthesis product by reverse phase radio high-performance liquid chromatography (HPLC) method are intended. Since the standard procedure for the quality control (QC) was not available, definition of chemical and radiochemical purity of 68Ga-PSMA I&T was carried out according to the Q2 (R1) ICH guideline. The standard QC tests were analyzed with Scintomics 8100 radio-HPLC system equipped with a radioactivity detector. The method was evaluated in terms of linearity, precision and accuracy, LOQ, robustness parameters, and specificity. To assess the radiochemical and chemical purity of 68Ga-PSMA I&T, the developed method was validated to apply safely to patients. An excellent linearity was found between 1μg/mL and 30 μg/mL, with a limit of detection and limit of quantitation of 0.286 μg/mL and 0.866 μg/mL, respectively for 68Ga-PSMA I&T. The recovery was 96.8 ± 3.8%. The quality control of the final product was performed many times with validated radio-HPLC method and was found to comply with ICH requirements, thus demonstrating the accuracy and robustness of the method for routine clinical practice. © This work is licensed under a Creative Commons Attribution 4.0 International License. | URI: | https://doi.org/10.3906/KIM-2003-19 | ISSN: | 1300-0527 |
Appears in Collections: | Scopus İndeksli Yayınlar Koleksiyonu / Scopus Indexed Publications Collection |
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Validation of HPLC method for the determination of chemical and r.pdf | 685.01 kB | Adobe PDF | View/Open |
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