迈向甲状腺激素校准参考物质纯度认证：一个先有鸡还是先有蛋的困境。
Towards the certification of the purity of calibrant reference materials for thyroid hormones: a chicken and egg dilemma.
作者信息
Toussaint B, Schimmel H, Klein C L, Wiergowski M, Emons H
机构信息
Institute for Reference Materials and Measurements, Joint Research Centre, European Commission, Geel, Belgium.
出版信息
J Chromatogr A. 2007 Jul 13;1156(1-2):236-48. doi: 10.1016/j.chroma.2006.11.095. Epub 2006 Dec 21.
The certification of the purity of CRMs intended for calibration, where no other certified material already exists for comparison, raises principle questions on how to determine the purity of a "first" calibrant in the calibration hierarchy. We developed and certified two calibration CRMs for their purity in thyroid hormones taking into consideration inorganic residues, residual solvents and organic impurities detectable by HPLC-UV and HPLC-MS. IRMM-468 was certified for a thyroxine (T(4)) mass fraction of 98.6+/-0.7% and IRMM-469 was certified for a 3,3',5-triiodothyronine (T(3)) mass fraction of 97.1+/-0.7%. The approach we used aims to determine the purity of these two CRMs to the best of our knowledge and taking all scientific aspects properly into account for the estimation of an uncertainty related to the stated purity.
对于用于校准的有证标准物质（CRM），若不存在其他已认证的物质可供比较，其纯度认证会引发关于如何确定校准层级中“首个”校准物纯度的原则性问题。我们开发并认证了两种用于甲状腺激素纯度的校准CRM，考虑了无机残留物、残留溶剂以及通过高效液相色谱 - 紫外（HPLC - UV）和高效液相色谱 - 质谱（HPLC - MS）可检测到的有机杂质。IRMM - 468被认证的甲状腺素（T(4)）质量分数为98.6±0.7%，IRMM - 469被认证的三碘甲状腺原氨酸（T(3)）质量分数为97.1±0.7%。我们采用的方法旨在尽我们所知确定这两种CRM的纯度，并在估计与规定纯度相关的不确定度时适当考虑所有科学方面。
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