Quality control procedure for 6-[18F]fluoro-L-DOPA: a presynaptic PET imaging ligand for brain dopamine neurons.
Quality control procedure for 6-[18F]fluoro-L-DOPA: a presynaptic PET imaging ligand for brain dopamine neurons.
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6-[18F]氟-L-多巴的质量控制程序：脑多巴胺神经元的突触前 PET 成像配体。
DOI：
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发表时间：
1989
影响因子：
9.3
通讯作者：
C. Chiueh
中科院分区：
文献类型：
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作者：
Jia;Su‐Jan Huang;Ronald D. Finn;K. Kirk;B. Francis;H. Adams;R. Cohen;C. Chiueh
本研究的目标是建立临床使用 6-[18F]氟-L-DOPA (6-[18F]-DOPA) 作为脑多巴胺神经元选择性突触前正电子发射断层扫描 (PET) 成像配体的质量控制程序。使用 5-mu C-18 反相柱和离子对流动相的高效液相色谱程序用于定量 6-[18F]-DOPA。 6-[ 18 F]-DOPA 的放射化学纯度通过 HPLC 级分中的 18 F 放射性测量，而化学纯度通过灵敏度为 25 pg 的安培电化学检测器测定。对临床前试验中使用的连续八批高纯度 6-[18F]-DOPA 样品进行的质量控制表明，PET 成像配体 6-[18F]-DOPA 的化学和/或放射化学纯度大于 97 +/- 0.5%，比活性为 365 +/- 31 mCi/mmol。了解并保证 PET 配体的放射化学纯度对于解释临床 PET 成像结果至关重要。这种质量控制的保证将能够对使用不同放射性药物程序从各个医疗中心获得的 6-[18F]-DOPA/PET 数据进行比较。
The goal of the current study was to establish a quality control procedure for clinical use of 6-[18F]fluoro-L-DOPA (6-[18F]-DOPA) as a selective presynaptic positron emission tomographic (PET) imaging ligand for brain dopamine neurons. A high performance liquid chromatographic procedure using a 5-mu C-18 reverse phase column and ion-pairing mobile phase was used for the quantification of 6-[18F]-DOPA. The radiochemical purity of 6-[18F]-DOPA was measured by 18F radioactivity in HPLC fractions while the chemical purity was determined by an amperometric electrochemical detector with a sensitivity of 25 pg. Quality control of eight consecutive batches of highly purified 6-[18F]-DOPA sample used in a pre-clinical trial revealed that the chemical and/or radiochemical purity of the PET imaging ligand, 6-[18F]-DOPA was greater than 97 +/- 0.5% with a specific activity of 365 +/- 31 mCi/mmol. The knowledge and assurance of radiochemical purity of PET ligands are essential for the interpretation of clinical PET imaging results. The assurance of such quality control would enable comparisons of 6-[18F]-DOPA/PET data obtained from various medical centers using different radiopharmaceutical procedures.