结晶
降水
水合物
盐(化学)
粒径
水溶液
材料科学
播种
过程(计算)
化学工程
工艺工程
过饱和度
粒子(生态学)
计算机科学
化学
热力学
有机化学
物理
地质学
工程类
气象学
操作系统
海洋学
作者
Abhishek Malik,Debasis Hazra,G. Steele,Sharmistha Pal
标识
DOI:10.1016/j.cherd.2020.09.021
摘要
A case study highlighting the risk of generating undesired hydrate polymorph following seeded distillative crystallization of an active pharmaceutical ingredient (API) from aqueous alcoholic solution and a strategy to overcome the issue is presented. The API salt had two known crystalline forms, the desired anhydrate Form A, and hydrate Form B. Importance of water content at the time of seeding to minimize the risk of precipitation of From B is emphasized. A novel approach termed distillative pathway diagram (DPD) was developed to assess the risk of generation of Form B at larger scales. The application of this diagram to determine process parameters to address form issues during distillative crystallization is explained. Given the likely risk of Form B precipitation predicted by DPD, an alternate non-aqueous antisolvent crystallization process was developed that provided both form and particle size control.
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