19798-87-9Relevant articles and documents
Identification and comparison of impurities in fluoxetine hydrochloride synthesized by seven different routes
Wirth, David D.,Miller, Marybeth S.,Boini, Sathish K.,Koenig, Thomas M.
, p. 513 - 519 (2000)
Fluoxetine HCl was prepared by seven different synthetic routes, all previously reported. The major impurities in each route were identified by GC/MS, HPLCMS, and gradient HPLC analysis. Impurities were classified as being derived from impurities in 4-chlorobenzotrifluoride, those arising during the SNAr reaction of this compound and 3-methylamino-1-phenyl-propanol, and those arising during the synthesis of this alcohol. Fifteen impurities belonging to the latter two categories were identified, and their structures were confirmed by synthesis of authentic material for most of the compounds. It was found that a variety of analytical tools was needed for complete characterization of the impurity profile of fluoxetine HCl and that purification of the intermediate and recrystallization of the drug itself are highly effective in minimizing the levels of the impurities.
