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Sci. Pharm. 2012, 80(1), 67-76; doi:10.3797/scipharm.1109-02

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

F-Synthesis, LLC, Posledniy Per., 11 (1), 107045 Moscow, Russia
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Received: 16 September 2011 / Accepted: 1 November 2011 / Published: 1 November 2011
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Abstract

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.
Keywords: Bortezomib; Chemical synthesis; HPLC; Mass spectrometry; Impurities; Oxidation; Chirality; Velcade Bortezomib; Chemical synthesis; HPLC; Mass spectrometry; Impurities; Oxidation; Chirality; Velcade
This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. (CC BY 4.0).

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MDPI and ACS Style

IVANOV, A.S.; SHISHKOV, S.V.; ZHALNINA, A.A. Synthesis and Characterization of Organic Impurities in Bortezomib Anhydride Produced by a Convergent Technology. Sci. Pharm. 2012, 80, 67-76.

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