Die Pharmazie is published by IMR Press from Volume 81 Issue 1 (2026). Previous articles were published by another publisher under the CC-BY licence, and they are hosted by IMR Press on imrpress.com as a courtesy and upon agreement.
Identification, synthesis, and control of efinaconazole impurities
Fuqiang Zhu , Jian Zhang , Hainimu Xiamuxi , Weiming Chen , Tianwen Hu , Xiaojun Yang , Guanghui Tian , Runyan Ni , Jian Li , Jin Suo , Yuanchao Xie , Jingshan Shen , Haji A. Aisa , Yang He
Article Info
Abstract
Impurities A–F were observed, identified, and confirmed during the efinaconazole production process. The possible formation pathways of the mentioned impurities were understood, and thereafter, a controlling strategy was established by locating the proper process parameters with the consideration of efficient cost and less waste as well. This impurity investigation is also essential for quality control of consistently delivering of qualified efinaconazole API.