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Collaborative Study to Validate Purity Determination by <sup>1</sup>H Quantitative NMR Spectroscopy by Using Internal Calibration Methodology
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- Miura Toru
- FUJIFILM Wako Pure Chemical Corporation
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- Sugimoto Naoki
- National Institute of Health Sciences
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- Bhavaraju Sitaram
- United States Pharmacopeial Convention
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- Yamazaki Taichi
- National Metrology Institute of Japan/National Institute of Advanced Industrial Science and Technology
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- Nishizaki Yuzo
- National Institute of Health Sciences
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- Liu Yang
- United States Pharmacopeial Convention
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- Bzhelyansky Anton
- United States Pharmacopeial Convention
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- Amezcua Carlos
- Baxter Healthcare FMC Corporation
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- Ray Joseph
- Baxter Healthcare University of Illinois at Chicago
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- Zailer Elina
- Spectral Service AG
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- Diehl Bernd
- Spectral Service AG
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- Gallo Vito
- Polytechnic University of Bari
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- Todisco Stefano
- Polytechnic University of Bari
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- Ofuji Katsuya
- Chugai Pharma Manufacturing Co., Ltd.
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- Fujita Kazuhiro
- SHIONOGI & Co., Ltd.
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- Higano Taro
- Taisho Pharmaceutical Co., Ltd.
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- Geletneky Christian
- Roche Diagnostics GmbH
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- Hausler Thomas
- Roche Diagnostics GmbH
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- Singh Neeraj
- Roche Diagnostics GmbH
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- Yamamoto Kana
- Japan Food Research Laboratories
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- Kato Tsuyoshi
- Japan Food Research Laboratories
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- Sawa Ryuichi
- Microbial Chemistry Research Foundation
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- Watanabe Ryuichi
- National Research Institute of Fisheries Science
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- Iwamoto Yoshiaki
- FUJIFILM Wako Pure Chemical Corporation
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- Goda Yukihiro
- National Institute of Health Sciences
Bibliographic Information
- Other Title
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- Highlighted Paper selected by Editor-in-Chief : Collaborative Study to Validate Purity Determination by ¹H Quantitative NMR Spectroscopy by Using Internal Calibration Methodology
- Collaborative Study to Validate Purity Determination by 1H Quantitative NMR Spectroscopy by Using Internal Calibration Methodology
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Description
<p>NMR spectroscopy has recently been utilized to determine the absolute amounts of organic molecules with metrological traceability since signal intensity is directly proportional to the number of each nucleus in a molecule. The NMR methodology that uses hydrogen nucleus (1H) to quantify chemicals is called quantitative 1H-NMR (1H qNMR). The quantitative method using 1H qNMR for determining the purity or content of chemicals has been adopted into some compendial guidelines and official standards. However, there are still few reports in the literature regarding validation of 1H qNMR methodology. Here, we coordinated an international collaborative study to validate a 1H qNMR based on the use of an internal calibration methodology. Thirteen laboratories participated in this study, and the purities of three samples were individually measured using 1H qNMR method. The three samples were all certified via conventional primary methods of measurement, such as butyl p-hydroxybenzoate Japanese Pharmacopeia (JP) reference standard certified by mass balance; benzoic acid certified reference material (CRM) certified by coulometric titration; fludioxonil CRM certified by a combination of freezing point depression method and 1H qNMR. For each sample, 1H qNMR experiments were optimized before quantitative analysis. The results showed that the measured values of each sample were equivalent to the corresponding reference labeled value. Furthermore, assessment of these 1H qNMR data using the normalized error, En-value, concluded that statistically 1H qNMR has the competence to obtain the same quantification performance and accuracy as the conventional primary methods of measurement.</p>
Journal
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- Chemical and Pharmaceutical Bulletin
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Chemical and Pharmaceutical Bulletin 68 (9), 868-878, 2020-09-01
The Pharmaceutical Society of Japan
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Keywords
Details 詳細情報について
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- CRID
- 1390285300186436480
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- NII Article ID
- 130007893846
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- NII Book ID
- AA00602100
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- ISSN
- 13475223
- 00092363
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- NDL BIB ID
- 030605992
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- PubMed
- 32565492
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- Text Lang
- en
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- Article Type
- journal article
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- Data Source
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- JaLC
- NDL Search
- Crossref
- PubMed
- CiNii Articles
- OpenAIRE
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- Abstract License Flag
- Disallowed