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Development of a Pure Certified Reference Material of D-Mannitol

A new certified reference material (CRM) of D-mannitol (GBW(E) 100681) has been developed in this study. We describe the preparation, structure determination, characterization, homogeneity study, stability study, as well as uncertainty estimation. The main component was 99.91% ± 0.01%. The moisture...

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Autores principales: Chen, Weizhu, Zhang, Yiping, Chen, Hui, Jin, Wenhui, Chen, Xiaoying, Huang, Xiaoyan, Xie, Yanrou, Fang, Hua, Hong, Zhuan
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10574156/
https://www.ncbi.nlm.nih.gov/pubmed/37836638
http://dx.doi.org/10.3390/molecules28196794
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author Chen, Weizhu
Zhang, Yiping
Chen, Hui
Jin, Wenhui
Chen, Xiaoying
Huang, Xiaoyan
Xie, Yanrou
Fang, Hua
Hong, Zhuan
author_facet Chen, Weizhu
Zhang, Yiping
Chen, Hui
Jin, Wenhui
Chen, Xiaoying
Huang, Xiaoyan
Xie, Yanrou
Fang, Hua
Hong, Zhuan
author_sort Chen, Weizhu
collection PubMed
description A new certified reference material (CRM) of D-mannitol (GBW(E) 100681) has been developed in this study. We describe the preparation, structure determination, characterization, homogeneity study, stability study, as well as uncertainty estimation. The main component was 99.91% ± 0.01%. The moisture content of the candidate CRM was 0.036% ± 0.002%, as measured by Karl Fischer titration. The nonvolatile and volatile impurities in the candidate CRM were all much less than 0.01%, which was determined by the ICP–MS and headspace GC–FID methods, respectively. The purity of the D-mannitol CRM was 99.9% ± 1.1% (k = 2), as measured by the two independent approaches involving the mass balance method (MB) and quantitative nuclear magnetic resonance technique (qNMR). The D-mannitol CRM was stable during the monitoring period for each temperature. It is stable for up to 48 months at room temperature and 28 days at 50 °C. The uncertainty was evaluated by combining the contributions from characterization, homogeneity, and stability. The developed D-mannitol CRM would effectively support method validation and proficiency testing, as well as effectively guarantee the accuracy, reliability, and comparability of results.
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spelling pubmed-105741562023-10-14 Development of a Pure Certified Reference Material of D-Mannitol Chen, Weizhu Zhang, Yiping Chen, Hui Jin, Wenhui Chen, Xiaoying Huang, Xiaoyan Xie, Yanrou Fang, Hua Hong, Zhuan Molecules Article A new certified reference material (CRM) of D-mannitol (GBW(E) 100681) has been developed in this study. We describe the preparation, structure determination, characterization, homogeneity study, stability study, as well as uncertainty estimation. The main component was 99.91% ± 0.01%. The moisture content of the candidate CRM was 0.036% ± 0.002%, as measured by Karl Fischer titration. The nonvolatile and volatile impurities in the candidate CRM were all much less than 0.01%, which was determined by the ICP–MS and headspace GC–FID methods, respectively. The purity of the D-mannitol CRM was 99.9% ± 1.1% (k = 2), as measured by the two independent approaches involving the mass balance method (MB) and quantitative nuclear magnetic resonance technique (qNMR). The D-mannitol CRM was stable during the monitoring period for each temperature. It is stable for up to 48 months at room temperature and 28 days at 50 °C. The uncertainty was evaluated by combining the contributions from characterization, homogeneity, and stability. The developed D-mannitol CRM would effectively support method validation and proficiency testing, as well as effectively guarantee the accuracy, reliability, and comparability of results. MDPI 2023-09-25 /pmc/articles/PMC10574156/ /pubmed/37836638 http://dx.doi.org/10.3390/molecules28196794 Text en © 2023 by the authors. https://creativecommons.org/licenses/by/4.0/Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/).
spellingShingle Article
Chen, Weizhu
Zhang, Yiping
Chen, Hui
Jin, Wenhui
Chen, Xiaoying
Huang, Xiaoyan
Xie, Yanrou
Fang, Hua
Hong, Zhuan
Development of a Pure Certified Reference Material of D-Mannitol
title Development of a Pure Certified Reference Material of D-Mannitol
title_full Development of a Pure Certified Reference Material of D-Mannitol
title_fullStr Development of a Pure Certified Reference Material of D-Mannitol
title_full_unstemmed Development of a Pure Certified Reference Material of D-Mannitol
title_short Development of a Pure Certified Reference Material of D-Mannitol
title_sort development of a pure certified reference material of d-mannitol
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10574156/
https://www.ncbi.nlm.nih.gov/pubmed/37836638
http://dx.doi.org/10.3390/molecules28196794
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