结晶
热重分析
差示扫描量热法
化学工程
二乙醇胺
材料科学
泥浆
结构精修
播种
溶剂
化学
有机化学
晶体结构
复合材料
热力学
工程类
物理
作者
Hitesh Batra,Raju Penmasta,Kenneth Phares,James P. Staszewski,Sudersan M. Tuladhar,David A. Walsh
摘要
Process development of treprostinil diethanolamine salt (UT-15C) involved the development of crystallization and slurry protocols to address the polymorph and morphology control issues. Two forms of UT-15C were evaluated by differential scanning calorimetry (DSC), X-ray powder diffraction (XRPD) and thermogravimetric analysis (TGA). Two crystallization solvent systems were developed to produce the thermodynamically stable form in high quality and yield. One solvent system gave dense particles while the other gave lighter and fly-away particles. Slurrying the lighter particles in heptane converted them to denser particles. The protocol was executed successfully on large-scale cGMP batches.
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