17α-羟孕酮纯度及其杂质分析方法的研究

Analysis of the Purity and Impurities in 17α-Hydroxyprogesterone

纯物质是溶液和基体标准物质制备的基础,也是基体中目标物准确测量的溯源源头。在纯物质准确定值研究中的关键和难点是各种杂质的准确定性和定量分析。采用质量平衡法测定了17α-羟孕酮的纯度,同时采用多种方法对17α-羟孕酮中的杂质进行了准确的定性和定量分析,最终采用定量核磁方法对定值结果进行了验证。

Pure substance is not only the foundation of both the preparation of solution and matrix reference materials, but also the traceable source of accurate measurements of the tar- get analyses in matrix in a metrological traceability system. The identification and quantification of all kinds of impurities in pure substance are the most critical and difficult among the analysis of pure substance. A mass balance method was used to determine the chemical purity of 17α-hydroxyprogesterone. Several methods were used to qualitative and quantitative ana- lyze the impurities of 17α-hydroxyprogesterone. Finally,quan- titative NMR method was used to verify the certified purity ValUe.