A. Burger et A. Lettenbichler, PREFORMULATION STUDIES ON DROLOXIFENE CITRATE - PSEUDOPOLYMORPHISM AND HYGROSCOPICITY, European journal of pharmaceutics and biopharmaceutics, 39(2), 1993, pp. 64-69
Investigation on droloxifene citrate revealed several pseudopolymorphi
c forms. Solvated crystal forms with differing amounts of water were p
repared by crystallization with alcohols and acetonitrile. At high rel
ative humidity, the substance, which is barely hygroscopic, formed a s
table monohydrate. Characterization of the different forms was carried
out by thermal analysis and by IR-spectroscopy or X-ray diffraction.
The solvent contents of the products were determined by H-1-NMR-spectr
oscopy and by enzymatic analysis.