ANTIMUSCARINIC COMPOUND HAVING A LOW CONTENT OF IMPURITIES

摘要

Substantially stable to degradation Fesoterodine fumarate, a process for its preparation and a process for the synthesis of specific degradation impurities of Fesoterodine fumarate are disclosed.

主权项

1. A process for the preparation of a substantially stable to degradation Fesoterodine fumarate, comprising:
the salification of Fesoterodine base with fumaric acid in the presence of a solvent wherein the molar ratio between Fesoterodine base and fumaric acid is comprised between about 1:0.10 and about 1:0.88; the precipitation of Fesoterodine fumarate from the resulting solution; the recovery of the solid.