Crystallization Engineering in Aza-Steroid: Application in the Development of Finasteride

Novel and robust crystallization approach based on solid solution formation was developed for the purification of finasteride. This is an unprecedented approach that describes the use of pure finasteride 1 to purify different lots of finasteride 1 (impure) contaminated with dihydrofinasteride 2.

本研究开发了一种基于固溶体形成（solid solution formation）的新型稳健结晶工艺，用于非那雄胺（finasteride）的纯化。该工艺为前所未有的创新方法，其阐述了利用纯态非那雄胺1，对多批次被二氢非那雄胺2（dihydrofinasteride 2）污染的不纯非那雄胺1进行纯化的具体路径。