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Identification, Characterization, Synthesis, and Strategy for Minimization of Potential Impurities Observed in the Synthesis of Solithromycin

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journal contribution
posted on 19.07.2017, 00:00 by Zhihong Zhong, Chong Du, Zhonghua Luo, Shuaihua Song, Gaohong Liao, Jia Yao, Siegfried Goldmann, Zhongqing Wang
Potential causes for the formation of synthetic impurities that are present in solithromycin (1) during laboratory development are studied in the article. These impurities were monitored by HPLC, and their structures are identified on the basis of MS and NMR spectroscopy. In addition to the synthesis and characterization of these seven impurities, strategies for minimizing them to the level accepted by the International Conference on Harmonization (ICH) are also described.