Development of Certified Reference Material of L-Thyroxine by Using Mass Balance and Quantitative Nuclear Magnetic Resonance Article Swipe
Qiang Zhao
,
Weifei Zhang
,
Dan Song
,
Xirui Zhou
,
Xianjiang Li
,
Huan Yao
,
Wenjing Xing
,
Hongmei Li
,
Jian Ma
,
Peng Xiao
·
YOU?
·
· 2025
· Open Access
·
· DOI: https://doi.org/10.3390/molecules30132840
YOU?
·
· 2025
· Open Access
·
· DOI: https://doi.org/10.3390/molecules30132840
L-thyroxine (T4) is an important hormone for diagnosing and evaluating thyroid function disorders. As outlined in ISO17511, having a certified reference material (CRM) is crucial for ensuring that the results of clinical tests are traceable to the SI-unit. This study employed two principal methods to evaluate the purity of T4, mass balance (MB) and quantitative nuclear magnetic resonance (qNMR), both of which are SI-traceable (International System of Units) approaches. The MB method involved a detailed analysis of impurities, including water, structurally related compounds, and volatile and non-volatile substances. A variety of techniques were employed to characterize T4 and its impurities, including liquid-phase tandem high-resolution mass spectrometry, ultraviolet spectrophotometry, infrared spectroscopy, and both 1H-NMR and 13C-NMR. Additionally, impurities were quantified using Karl Fischer coulometric titration, ion chromatography, gas chromatography–mass spectrometry, and inductively coupled plasma–mass spectrometry. In qNMR, ethylparaben was used as the internal standard for direct value assignment. The results showed T4 purities of 94.92% and 94.88% for the MB and qNMR methods, respectively. The water content was determined to be 3.563% (n = 6), representing the highest impurity content. Ten structurally related organic impurities were successfully separated, and five of them were quantified. Ultimately, a purity of 94.90% was assigned to T4 CRM, with an expanded uncertainty of 0.34% (k = 2).
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Metadata
- Type
- article
- Language
- en
- Landing Page
- https://doi.org/10.3390/molecules30132840
- https://www.mdpi.com/1420-3049/30/13/2840/pdf?version=1751512559
- OA Status
- gold
- References
- 25
- Related Works
- 10
- OpenAlex ID
- https://openalex.org/W4411973201
All OpenAlex metadata
Raw OpenAlex JSON
- OpenAlex ID
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https://openalex.org/W4411973201Canonical identifier for this work in OpenAlex
- DOI
-
https://doi.org/10.3390/molecules30132840Digital Object Identifier
- Title
-
Development of Certified Reference Material of L-Thyroxine by Using Mass Balance and Quantitative Nuclear Magnetic ResonanceWork title
- Type
-
articleOpenAlex work type
- Language
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enPrimary language
- Publication year
-
2025Year of publication
- Publication date
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2025-07-02Full publication date if available
- Authors
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Qiang Zhao, Weifei Zhang, Dan Song, Xirui Zhou, Xianjiang Li, Huan Yao, Wenjing Xing, Hongmei Li, Jian Ma, Peng XiaoList of authors in order
- Landing page
-
https://doi.org/10.3390/molecules30132840Publisher landing page
- PDF URL
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https://www.mdpi.com/1420-3049/30/13/2840/pdf?version=1751512559Direct link to full text PDF
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YesWhether a free full text is available
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goldOpen access status per OpenAlex
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https://www.mdpi.com/1420-3049/30/13/2840/pdf?version=1751512559Direct OA link when available
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Balance (ability), Nuclear magnetic resonance, Magnetic resonance imaging, Material balance, Certification, Chemistry, Physics, Medicine, Engineering, Radiology, Process engineering, Political science, Physical medicine and rehabilitation, LawTop concepts (fields/topics) attached by OpenAlex
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0Total citation count in OpenAlex
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25Number of works referenced by this work
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10Other works algorithmically related by OpenAlex
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| sustainable_development_goals[0].score | 0.7200000286102295 |
| sustainable_development_goals[0].display_name | Clean water and sanitation |
| citation_normalized_percentile.value | 0.34827194 |
| citation_normalized_percentile.is_in_top_1_percent | False |
| citation_normalized_percentile.is_in_top_10_percent | False |