Cinitapride Fumarate and its Impurities

Cinitapride Fumarate is indicated for the treatment of gastrointestinal disorders associated with motility disturbances such as gastroesophageal reflux disease, non-ulcer dyspepsia and delayed gastric emptying.  Reference standards of Cinitapride Fumarate API, and its pharmacopeial, non pharmacopeial impurities, and stable isotopes are listed below.