Aspects of melatonin manufacturing and requirements for a reliable active component.

Abstract

Commercially available melatonin was found to contain impurities associated with eosinophilia-myalgia syndrome (EMS). From sample analysis, remarkable differences in impurity profiles between the active ingredient from various suppliers could be found. An industrial process was developed which guarantees a high purity melatonin active ingredient. All potential impurities have been characterized and synthetized for analytical conformity with pharmaceutical regulations. To avoid any side effects from impurities, only high-purity melatonin should be utilized from the laboratory through to commercialization.