Evaluation of Uncertainty in the Measurement of Residual Solvents in Fluorine [18F] Deoxyglucose Injection by HS-GC
Department of Analytical Technology / Department for Supervision Testing and Researches, Guangdong Institute for Drug Control, Guangzhou 510663, China
| Abstract: | Objective: To standardize the data evaluation method for quantitative drug testing, accurately reflect the reliability of drug analysis results, identify error risks in sample pretreatment, instrument testing, standard preparation, and other processes, and complete the uncertainty measurement of residual solvents in radioactive drug fluorine [18F] deoxyglucose injection. Method: According to the JJF 1059.1 measurement uncertainty evaluation standard, a mathematical model for measuring the uncertainty of residual solvents in fluoride [18F] deoxyglucose injection was established to analyze the measurement process and systematically analyze the sources of uncertainty in the experimental process. Calculate the various uncertainty components to obtain the composite uncertainty and expanded uncertainty of the measurement results. The determination results of residual solvents acetone, ethanol, and acetonitrile in the fluoride [18F] deoxyglucose injection sample were 0.000; 0.005867±0.000194%； 0.000535 ± 0.000018%, the second term is the value of the expanded uncertainty U, k=2. Conclusion: Based on the measurement results and considering the influence of uncertainty, it can be concluded that the test results of residual solvents in the sample are in compliance with regulations. The evaluation results can truly reflect the measurement error level of the method. The study has identified key error control points, which can provide important basis for the standardized application of this method, scientific interpretation of detection results, and data traceability. It also provides reference for investigating the influencing factors of residual solvent measurement process in samples. |
| Keywords: | Radioactive Drugs; Fluorine [18F] Deoxyglucose Injection; Residual Solvents; HS-GC; Uncertainty |
| DOI: | 10.57237/j.mrf.2026.02.002 |
View:
Downloads:
Received: 19 March 2026
Accepted: 29 May 2026
Published Online: 8 June 2026
Funding
| 1. | 广东省药品监督管理局科技创新项目 (2024ZDB01) |
| 2. | 广东省药品检验所项目 (SN2024007) |
References
| [1] | Notice on Issuing the Plan for Promoting the Research and Application of Radiopharmaceuticals (Guo Wei Ke Jiao Fa (2023) No. 8). |
| [2] | General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China. Evaluation and Expression of Uncertainty in Measurement: JJF1059.1—2012 [S]. Beijing: China Standards Press, 2012. |
| [3] | Li Yungang, Zhang Xiaojun, Liu Jian, et al. Gas Chromatography Measurement of Organic Solvent Residues in Positron Radiopharmaceuticals and Analysis of Causes [J]. Isotopes (同位素), 2013, 26(3): 152-157. https://doi.org/10.7538/tws.2013.26.03.0152 |
| [4] | China National Accreditation Service for Conformity Assessment. Guide for Uncertainty Evaluation in Chemical Analysis: CNAS-GL006:2019 [S]. Beijing: China Metrology Press, 2019. |
| [5] | China National Accreditation Service for Conformity Assessment. Requirements for Measurement Uncertainty: CNAS-CL01-G003:2021 [S]. Beijing: China Metrology Press, 2021. |
| [6] | General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China, Standardization Administration of China. Evaluation and Expression of Uncertainty in Measurement: GB/T 27418-2017 [S]. Beijing: China Standards Press, 2018. |
| [7] | Certification and Accreditation Administration of the People's Republic of China. Guide for Uncertainty Evaluation in Chemical Analysis: RB/T 030—2020 [S]. Beijing: China Standards Press, 2021. |
| [8] | General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China. Evaluation of Uncertainty in Chemical Analysis: JJF 1135-2005 [S]. Beijing: China Metrology Press, 2005. |
| [9] | Li Jianguo, Qin Xiujun, Hu Bo, et al. Research Status and Prospect of Radiopharmaceuticals [J]. Chinese Journal of Drug Evaluation (中国药物警戒), 2019, 16(1): 27-31. https://doi.org/10.19803/j.1672-8629.2019.01.008 |
| [10] | Wang jiaqin, Wang qi, Zhang dongjie, et al. Uncertainty evaluation on the determination of norvancomycin in human cerebrospinal fluid by UPLC-MS/MS [J]. Chinese Journal of Pharmacovigilance (中国药物警戒), 2023, 20(12): 1346-1350. https://doi.org/10.19875/j.cnki.cjph.2023.12.015 |
| [11] | Wang jiaqin, Wang qi, Shi weizhong, et al. Uncertainty evaluation for the determination of 6PM in Beagle dog plasma by UPLC-MS/MS [J]. Chinese Journal of Pharmacovigilance (中国药物警戒), 2023, 20(12): 1321-1325. https://doi.org/10.19803/j.1672-8629.20230593 |
Join the Editorial Board
We invite active, qualified and high profile scientists and researchers to join as Editorial Board Members.
Join UsBecome a Reviewer
Scholars with a strong interest in reviewing are invited to join the reviewer panel to ensure the quality of the research to be published.
Join Us