Kang Inseon, Seo Yoondam, Lee Kangmi, Lee Hyeon-Jeong, Son Junghyun, Lee Hwa Jeong, Oh Min-Kyu, Min Hophil
Doping Control Center, Korea Institute of Science and Technology, Hwarang-ro 14-gil, Seongbuk-gu, Seoul 02792, Republic of Korea.
Graduate School of Pharmaceutical Sciences, Ewha Womans University, 52 Ewhayeodae-Gil, Seodaemun-Gu, Seoul 03760, Republic of Korea.
ACS Omega. 2024 Mar 8;9(11):12689-12697. doi: 10.1021/acsomega.3c08316. eCollection 2024 Mar 19.
Biomatrix-based reference materials (RMs) improve the quality of laboratory test results by better representing actual samples. However, a matrix RM of ephedrine (EP) for threshold substances that require accurate analysis results has not yet been developed. Therefore, this study aimed to develop an in-house matrix RM for EP and subsequently apply it to analytical procedures. During the development of the in-house matrix EP RM, the system underwent homogeneity and stability studies. Additionally, it was subjected to interlaboratory comparison study in 11 laboratories, including 10 World Anti-Doping Agency (WADA)-accredited laboratories and our laboratory. Stability testing revealed no significant changes in the RM characteristics. For homogeneity, 10 random batches out of 200 were analyzed to confirm the uniformity within and between bottles. These results, combined with data from 11 laboratories, ensured retroactive validation. The traceability value of the in-house matrix EP RM was assigned as 9.83 ± 0.57 μg/mL ( = 2) by interlaboratory comparison studies and traceable uncertain evaluation. The feasibility of this method as a single calibration standard was confirmed in two laboratories. This substance is reliable and consistent for quality control during EP quantification, ensuring accurate and trustworthy outcomes. Consequently, this study establishes a framework and guidelines for producing in-house matrix RMs and serves as a reference for generating similar matrix RMs in other contexts.
基于生物基质的参考物质（RM）通过更准确地模拟实际样品来提高实验室检测结果的质量。然而，对于需要精确分析结果的阈值物质麻黄碱（EP），尚未开发出基质RM。因此，本研究旨在开发一种用于EP的内部基质RM，并随后将其应用于分析程序。在内部基质EP RM的开发过程中，对该系统进行了均匀性和稳定性研究。此外，它还在11个实验室进行了实验室间比对研究，其中包括10个世界反兴奋剂机构（WADA）认可的实验室和我们的实验室。稳定性测试表明RM特性没有显著变化。对于均匀性，从200个批次中随机抽取10个批次进行分析，以确认瓶内和瓶间的均匀性。这些结果与11个实验室的数据相结合，确保了追溯性验证。通过实验室间比对研究和可追溯不确定度评估，将内部基质EP RM的溯源值确定为9.83±0.57μg/mL（ = 2）。在两个实验室中证实了该方法作为单一校准标准的可行性。该物质在EP定量过程中用于质量控制是可靠且一致的，确保了准确和可信赖的结果。因此，本研究建立了生产内部基质RM的框架和指南，并为在其他情况下生成类似的基质RM提供了参考。
