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アイテム
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The most common method for the determination of the substance of [11C]choline or DMAE was by co-injection of carrier-choline or DMAE method, and by two separate analysis LC system and gas chromatography [2-4]. The quality control procedures for 11C-labeled radiopharmaceuticals is acquired rapid assessment due to short half-life radionuclide (about 20 min). Thus, we developed a rapid and simultaneous measurement method for the molar radioactivity, radiochemical purity, and chemical impurity of the [11C]choline injection using the radio-HPLC coupled with the corona-charged aerosol detector (CAD). Methods: The molar radioactivity, radiochemical purity, and chemical impurity (DMAE) of the [11C]choline injection was measured using the radio-HPLC-CAD with the post-column method. We also validated the measurement of choline and DMAE using this HPLC, and evaluated these parameters of the accuracy, precision, specificity, quantitation of limit, and linearity. Results: The molar radioactivity, radiochemical purity, and chemical impurity were over 130 GBq/μmol (over 0.1 μg/mL) at end of synthesis (EOS), over 95% at EOS, and less than 0.5 μg/mL of DMAE, respectively. In the validation, the percentages of recovery of choline and DMAE were within 100±5%. The RSD of choline and DMAE were less than 10%. Resolution between obtained choline and DMAE peak was over 1.5. The limit of quantitation of choline and DMAE was 0.1 and 0.5 μg/mL, respectively. The coefficient of correlation (R2) of choline (0.1-50 μg/mL) and DMAE (0.5-50 μg/mL) found to be \u003e0.9999. Conclusions: We developed and optimized the simultaneous measurement method for the molar radioactivity, radiochemical purity, and chemical impurity of the [11C]choline injection using the radio-HPLC-CAD with the post-column method.\nReferences: [1] Giovacchini G, et al. Eur J Nucl Med Mol Imaging. 2017;44:1751-76. [2] Mishani E, et al. Nucl Med Biol. 2002;39:359-62. [3] Shao X, et al. 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The simultaneous measurement method for the molar radioactivity, radiochemical purity, and chemical impurity of the [11C]choline injection
https://repo.qst.go.jp/records/72763
https://repo.qst.go.jp/records/727638ace3994-5406-4f14-a643-552c5d541f50
Item type | 会議発表用資料 / Presentation(1) | |||||
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公開日 | 2018-04-27 | |||||
タイトル | ||||||
タイトル | The simultaneous measurement method for the molar radioactivity, radiochemical purity, and chemical impurity of the [11C]choline injection | |||||
言語 | ||||||
言語 | eng | |||||
資源タイプ | ||||||
資源タイプ識別子 | http://purl.org/coar/resource_type/c_c94f | |||||
資源タイプ | conference object | |||||
アクセス権 | ||||||
アクセス権 | metadata only access | |||||
アクセス権URI | http://purl.org/coar/access_right/c_14cb | |||||
著者 |
Hashimoto, Hiroki
× Hashimoto, Hiroki× Kawamura, Kazunori× Furutsuka, Kenji× Kariya, Kaori× Nengaki, Nobuki× Zhang, Ming-Rong× 橋本 裕輝× 河村 和紀× 古塚 賢士× 狩谷 香× 念垣 信樹× 張 明栄 |
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抄録 | ||||||
内容記述タイプ | Abstract | |||||
内容記述 | Background/Aims: [11C]Choline has been extensively used clinically for imaging prostate cancer [1]. [11C]Choline is prepared by 11C-methylation of [11C]methyl iodide and 2-dimethylaminoethanol (DMAE). It is important to determine accurately the quantity of DMAE in the final product. The most common method for the determination of the substance of [11C]choline or DMAE was by co-injection of carrier-choline or DMAE method, and by two separate analysis LC system and gas chromatography [2-4]. The quality control procedures for 11C-labeled radiopharmaceuticals is acquired rapid assessment due to short half-life radionuclide (about 20 min). Thus, we developed a rapid and simultaneous measurement method for the molar radioactivity, radiochemical purity, and chemical impurity of the [11C]choline injection using the radio-HPLC coupled with the corona-charged aerosol detector (CAD). Methods: The molar radioactivity, radiochemical purity, and chemical impurity (DMAE) of the [11C]choline injection was measured using the radio-HPLC-CAD with the post-column method. We also validated the measurement of choline and DMAE using this HPLC, and evaluated these parameters of the accuracy, precision, specificity, quantitation of limit, and linearity. Results: The molar radioactivity, radiochemical purity, and chemical impurity were over 130 GBq/μmol (over 0.1 μg/mL) at end of synthesis (EOS), over 95% at EOS, and less than 0.5 μg/mL of DMAE, respectively. In the validation, the percentages of recovery of choline and DMAE were within 100±5%. The RSD of choline and DMAE were less than 10%. Resolution between obtained choline and DMAE peak was over 1.5. The limit of quantitation of choline and DMAE was 0.1 and 0.5 μg/mL, respectively. The coefficient of correlation (R2) of choline (0.1-50 μg/mL) and DMAE (0.5-50 μg/mL) found to be >0.9999. Conclusions: We developed and optimized the simultaneous measurement method for the molar radioactivity, radiochemical purity, and chemical impurity of the [11C]choline injection using the radio-HPLC-CAD with the post-column method. References: [1] Giovacchini G, et al. Eur J Nucl Med Mol Imaging. 2017;44:1751-76. [2] Mishani E, et al. Nucl Med Biol. 2002;39:359-62. [3] Shao X, et al. Appl Radiat Isot. 2011;69:403-9. [4] Biasiotto G, et al. Med Chem. 2012;8:1182-9. \n (Abstracts are to be no more than 300 words. References, Title and authors details are not included in the word count. Abstracts should not contain bullet points.) |
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会議概要(会議名, 開催地, 会期, 主催者等) | ||||||
内容記述タイプ | Other | |||||
内容記述 | 12th World Congress of the World Federation of Nuclear Medicine and Biology | |||||
発表年月日 | ||||||
日付 | 2018-04-21 | |||||
日付タイプ | Issued |