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盐酸普萘洛尔的双相相图与晶析法手性拆分。

The binary phase diagram of propranolol hydrochloride and crystallization-based enantioseparation.

机构信息

Max-Planck-Institut für Dynamik komplexer technischer Systeme, Magdeburg, Germany.

出版信息

J Pharm Sci. 2010 Apr;99(4):1762-73. doi: 10.1002/jps.21943.

DOI:10.1002/jps.21943
PMID:19798754
Abstract

Inconsistent results were reported for the solid-state nature of the racemic species of the pharmaceutical relevant compound propranolol hydrochloride. In this work the binary phase diagram of the propranolol hydrochloride enantiomers is studied. Differential scanning calorimetry (DSC), X-ray powder diffraction (XRPD), and high performance liquid chromatography (HPLC) were used as analytical methods. The type of the racemic species, the presence and extent of partial solid solutions and the stability regions of polymorphic forms in the system were investigated. The identified binary phase diagram is sketched. Finally, the feasibility of crystallization-based resolution is discussed.

摘要

对于具有药用相关化合物盐酸普萘洛尔的外消旋体的固态性质,报告了不一致的结果。在这项工作中,研究了盐酸普萘洛尔对映异构体的二元相图。差示扫描量热法(DSC)、X 射线粉末衍射(XRPD)和高效液相色谱(HPLC)被用作分析方法。研究了外消旋体的类型、部分固溶体的存在和程度以及系统中多晶型形式的稳定区域。绘制了所确定的二元相图。最后,讨论了基于结晶的拆分的可行性。

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