Synthesis and Characterization of Organic Impurities in Bortezomib Anhydride Produced by a Convergent Technology

A profile of impurities in bortezomib anhydride, produced by a recently developed convergent technology, has been characterized. HPLC-MS analysis of the drug essence revealed three impurities: an epimer of bortezomib, resulting from partial racemization of l-phenylalanine’s stereogenic center during...

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Autores principales: Ivanov, Andrey S., Shishkov, Sergey V., Zhalnina, Anna A.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Österreichische Apotheker-Verlagsgesellschaft 2012
Materias:
Research Article
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3293353/
https://www.ncbi.nlm.nih.gov/pubmed/22396904
http://dx.doi.org/10.3797/scipharm.1109-02
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author Ivanov, Andrey S.
Shishkov, Sergey V.
Zhalnina, Anna A.
author_facet Ivanov, Andrey S.
Shishkov, Sergey V.
Zhalnina, Anna A.
author_sort Ivanov, Andrey S.
collection PubMed
description A profile of impurities in bortezomib anhydride, produced by a recently developed convergent technology, has been characterized. HPLC-MS analysis of the drug essence revealed three impurities: an epimer of bortezomib, resulting from partial racemization of l-phenylalanine’s stereogenic center during the chemical synthesis, and two epimeric products of oxidative degradation of bortezomib, in which boron is replaced by the OH group. The impurities were obtained by chemical synthesis and characterized by physical methods.
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spelling pubmed-32933532012-03-06 Synthesis and Characterization of Organic Impurities in Bortezomib Anhydride Produced by a Convergent Technology Ivanov, Andrey S. Shishkov, Sergey V. Zhalnina, Anna A. Sci Pharm Research Article A profile of impurities in bortezomib anhydride, produced by a recently developed convergent technology, has been characterized. HPLC-MS analysis of the drug essence revealed three impurities: an epimer of bortezomib, resulting from partial racemization of l-phenylalanine’s stereogenic center during the chemical synthesis, and two epimeric products of oxidative degradation of bortezomib, in which boron is replaced by the OH group. The impurities were obtained by chemical synthesis and characterized by physical methods. Österreichische Apotheker-Verlagsgesellschaft 2012 2011-11-01 /pmc/articles/PMC3293353/ /pubmed/22396904 http://dx.doi.org/10.3797/scipharm.1109-02 Text en © Ivanov et al.; licensee Österreichische Apotheker-Verlagsgesellschaft m. b. H., Vienna, Austria. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/3.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
spellingShingle Research Article
Ivanov, Andrey S.
Shishkov, Sergey V.
Zhalnina, Anna A.
Synthesis and Characterization of Organic Impurities in Bortezomib Anhydride Produced by a Convergent Technology
title Synthesis and Characterization of Organic Impurities in Bortezomib Anhydride Produced by a Convergent Technology
title_full Synthesis and Characterization of Organic Impurities in Bortezomib Anhydride Produced by a Convergent Technology
title_fullStr Synthesis and Characterization of Organic Impurities in Bortezomib Anhydride Produced by a Convergent Technology
title_full_unstemmed Synthesis and Characterization of Organic Impurities in Bortezomib Anhydride Produced by a Convergent Technology
title_short Synthesis and Characterization of Organic Impurities in Bortezomib Anhydride Produced by a Convergent Technology
title_sort synthesis and characterization of organic impurities in bortezomib anhydride produced by a convergent technology
topic Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3293353/
https://www.ncbi.nlm.nih.gov/pubmed/22396904
http://dx.doi.org/10.3797/scipharm.1109-02
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