Argos Zyklotron GmbH, Seilerstaette 4, Linz, Austria.
Nucl Med Biol. 2011 Nov;38(8):1143-8. doi: 10.1016/j.nucmedbio.2011.05.006. Epub 2011 Jul 7.
With respect to the broad application of [(18)F-methyl]fluorocholine (FCH), there is a need for a safe, but also efficient and convenient way for routine quality control of FCH. Therefore, a GC- method should be developed and validated which allows the simultaneous quantitation of all chemical impurities and residual solvents such as acetonitrile, ethanol, dibromomethane and N,N-dimethylaminoethanol.
Analytical GC has been performed with a GC-capillary column Optima 1701 (50 m×0.32 mm), and a pre-column deactivated capillary column phenyl-Sil (10 m×0.32) in line with a flame ionization detector (FID) was used. The validation includes the following tests: specificity, range, accuracy, linearity, precision, limit of detection (LOD) and limit of quantitation (LOQ) of all listed substances.
The described GC method has been successfully used for the quantitation of the listed chemical impurities. The specificity of the GC separation has been proven by demonstrating that the appearing peaks are completely separated from each other and that a resolution R≥1.5 for the separation of the peaks could be achieved. The specified range confirmed that the analytical procedure provides an acceptable degree of linearity, accuracy and precision. For each substance, a range from 2% to 120% of the specification limit could be demonstrated. The corresponding LOD values were determined and were much lower than the specification limits.
An efficient and convenient GC method for the quality control of FCH has been developed and validated which meets all acceptance criteria in terms of linearity, specificity, precision, accuracy, LOD and LOQ.
鉴于[(18)F-甲基]氟胆碱（FCH）的广泛应用，需要有一种安全、高效且方便的方法来对 FCH 进行常规质量控制。因此，应该开发并验证一种 GC 方法，该方法能够同时定量所有化学杂质和残留溶剂，如乙腈、乙醇、二溴甲烷和 N，N-二甲基氨基乙醇。
采用 GC 毛细管柱 Optima 1701（50 m×0.32 mm）和预柱去活毛细管柱苯基-Sil（10 m×0.32）进行分析 GC，与火焰离子化检测器（FID）联用。验证包括以下测试：专属性、范围、准确度、线性、精密度、检测限（LOD）和定量限（LOQ）。
所描述的 GC 方法已成功用于定量列出的化学杂质。GC 分离的专属性已通过证明出现的峰彼此完全分离以及峰的分离分辨率 R≥1.5 得到证明。指定的范围证实了分析程序提供了可接受的线性度、准确度和精密度。对于每种物质，都可以证明在规格限度的 2%至 120%范围内。相应的 LOD 值已确定，远低于规格限度。
已经开发并验证了一种用于 FCH 质量控制的高效、方便的 GC 方法，该方法在线性度、专属性、精密度、准确度、LOD 和 LOQ 方面均符合所有验收标准。
