HS-GC法测定氟[18F]脱氧葡糖注射液中残留溶剂测量不确定度评定
1. 广东省药品检验所, 检验技术研究室/监督检验研究室, 广东广州 510663
2. 广东省药监局放射性药品质量研究与评价重点实验室, 广东广州 510663
3. 国家药监局药品快速检验技术重点实验室, 广东广州 510663
| 摘 要： | 目的 为规范药品定量检测的数据评价方式，精确反映药物分析结果的可靠性，排查样品前处理、仪器检测、标准配制等环节的误差风险，完成放射性药品氟[18F]脱氧葡糖注射液残留溶剂测量的不确定度。方法 依据JJF 1059.1测量不确定度评定规范，通过建立氟[18F]脱氧葡糖注射液残留溶剂测量的不确定度数学模型，分析测量过程，系统分析实验过程中的不确定度来源。计算各个不确定度分量，得到测定结果的合成不确定度和扩展不确定度。结果 样品氟[18F]脱氧葡糖注射液中残留溶剂丙酮、乙醇、乙腈的测定结果分别为：0.000；0.005867±0.000194%；0.000535±0.000018%，第二项为扩展不确定度 U 的值，k=2。结论 根据测定结果，考虑不确定度影响后，可以判定该样品残留溶剂的检验结果结论为符合规定。评定结果能够真实反映方法的测量误差水平。研究明确了关键误差控制点可为该方法的规范化应用、检测结果的科学解释及数据溯源提供重要依据，也为考察样品中残留溶剂测量过程的影响因素提供了参考。 |
| 关 键 词： | 放射性药品; 氟[18F]脱氧葡糖注射液; 残留溶剂; HS‐GC; 不确定度 |
| DOI： | 10.57237/j.mrf.2026.02.002 |
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收稿日期: 2026-03-19
接受日期: 2026-05-29
在线出版日期: 2026-06-08
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 |
基金
| 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) |
参考文献
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