Determination of Organic Solvent in Radioactive Tracer ［18F］PBR06 Injection by Cold-on-Column Inlet Gas Chromatography
To develop a quality control inspection method for determining content of ethanol and residual solvent in radiolabeled tracer ［18F］PBR06 injection which is used for positron emission tomography imaging. Stabilwax CG column (30 m×0.52 mm, 1 μm) is selected. Temperature program: set initial temperatur...
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| Format: | Article |
| Language: | zho |
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Editorial Board of Journal of Isotopes
2021-06-01
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| Series: | Journal of Isotopes |
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| Online Access: | http://www.tws.org.cn/CN/10.7538/tws.2021.34.03.0288 |
| Summary: | To develop a quality control inspection method for determining content of ethanol and residual solvent in radiolabeled tracer ［18F］PBR06 injection which is used for positron emission tomography imaging. Stabilwax CG column (30 m×0.52 mm, 1 μm) is selected. Temperature program: set initial temperature at 55 ℃, kept for 4 min, then increased to 200 ℃ at rate of 40 ℃/min, hold for 3 min. Hydrogen flame ionization detector is used and the temperature is 240 ℃. The carrier gas is high-purity nitrogen, and the inlet pressure is 5.5 psi (37.9 kPa). The temperature of Cold-on-Column inlet follows the column temperature. The results show that ethanol, acetonitrile, and DMSO have good linear relationships in the concentration range of 0.5%-12.0% (v·v-1), 0.004 0%-0.048 0% (g·g-1) and 0.025%-0.590% (g·g-1). The limit of quantification (S/N=10) for ethanol, acetonitrile, and DMSO is 0.15% (v·v-1), 0.002 9% (g·g-1) and 0.008 2% (g·g-1). The limits of detection (S/N=3) is 0.05% (v·v-1), 0.000 87% (g·g-1) and 0.002 5% (g·g-1), respectively. The results of the standard addition recovery show that the method has good accuracy. The Cold-on-Column inlet GC method developed in this study is suitable for inspecting the content of ethanol, acetonitrile and DMSO in ［18F］PBR06 injection. The results of the method validation meet the requirements of the Chinese Pharmacopoeia 2020 edition. The method is accurate and time-saving, requiring only a small volume of sample, which is beneficial to improve the efficiency of product quality control inspection.
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| ISSN: | 1000-7512 1000-7512 |