The binary phase diagram of propranolol hydrochloride and crystallization‐based enantioseparation

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. © 2009 Wiley‐Liss, Inc. and the American Pharmacists Association J Pharm Sci 99: 1762-1773, 2010