PROBLEM TO BE SOLVED: To provide methods for producing viloxazine and various salts thereof, and viloxazine-associated compounds, such as novel intermediate reaction products and polymorphs thereof, and to provide a pharmaceutically active ingredient of substantially pure viloxazine HCl while avoiding undesirable impurities.SOLUTION: The present invention provides viloxazine, as well as methods for synthesis, identification and characterization of some important metabolites of viloxazine and novel intermediates of precursors of metabolites, and separation, specification and characterization of novel polymorphs of viloxazine. The present invention also provides a composition which essentially consists of viloxazine or a pharmaceutically acceptable salt thereof and which is substantially pure, wherein less than about 1.5 μg of any genotoxic impurities per predicted human daily dosage are comprised.SELECTED DRAWING: Figure 4【課題】ビロキサジン及びその様々な塩、並びにその新規な中間体反応生成物及び多形等のビロキサジン関連の化合物を製造する方法、および、望ましくない不純物を避けながらビロキサジンＨＣｌの実質的に純粋な医薬品有効成分の提供。【解決手段】ビロキサジン、並びにビロキサジンの一部の重要な代謝産物及び代謝産物の前駆体の新規な中間体の合成及び特定及び特性化のための方法、および、ビロキサジンの新規な多形の分離、特定及び特性化。さらに、ビロキサジン又はその薬学的に許容される塩から本質的になる実質的に純粋な組成物であって、予測されるヒトの１日投与量当たり約１．５μｇ未満の任意の遺伝毒性不純物を含む、組成物。【選択図】図４
