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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Detalles Bibliográficos
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
Descripción
Sumario: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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