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.

中文翻译：

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索洛霉素合成中发现的潜在杂质的鉴定，表征，合成和策略

本文研究了在实验室开发过程中形成于索霉素（1）中的合成杂质形成的潜在原因。通过HPLC监测这些杂质，并基于MS和NMR光谱法鉴定它们的结构。除了这七个杂质的合成和表征之外，还描述了将其最小化到国际协调会议（ICH）接受的水平的策略。