Effects of Temperature and Relative Humidity on the Solid-State Chemical Stability of Ranitidine Hydrochloride
作者:Reiko Teraoka、Makoto Otsuka、Yoshihisa Matsuda
DOI:10.1002/jps.2600820611
日期:1993.6
critical relativehumidity (CRH) of the ranitidine HCl bulk powder was approximately 67% relativehumidity (RH). The amount of water adsorbed onto the sample above the CRH was proportional to the RH level. The percent degradation of the powder below 50% RH was almost negligible because, at this level, it was a solid. The percent degradation at 60-70% RH was higher than that above 70% RH. Ranitidine HCl
The present invention relates to a novel process for the preparation of nizatidine, N-[2-[[[2-(dimethylamino)methyl-4-thiazolyl]methyl]thio]ethyl]-N'-methyl-2 -nitro-1,1-ethenediamine, and pharmaceutically acceptable salts thereof, comprising reacting a compound of formula II ##STR1## with a compound of formula III ##STR2## or a salt thereof, in which X represents a leaving group, in the presence of methylamine in the presence of an inert diluent.