Highly purified batches of pharmaceutical grade 1-deoxygalactose nojirimycin compounds

Methods for producing active pharmaceutical ingredient (API) grade migalastat hydrochloride are provided, as well as methods for purifying intermediate grade migalastat hydrochloride. Further provided are methods of producing [(2R, 3S, 4R, 5S)-1-butyl-2-(hydroxymethyl) piperidine-3, 4, 5-triol hydro...

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Hauptverfasser: SHETH, KAMLESH, TESLER SERGEY
Format: Patent
Sprache:chi ; eng
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Zusammenfassung:Methods for producing active pharmaceutical ingredient (API) grade migalastat hydrochloride are provided, as well as methods for purifying intermediate grade migalastat hydrochloride. Further provided are methods of producing [(2R, 3S, 4R, 5S)-1-butyl-2-(hydroxymethyl) piperidine-3, 4, 5-triol hydrochloride (rucastat hydrochloride) and other 1-deoxygalactose nojirimycin compounds, as well as methods of purifying the intermediate grade rucastat hydrochloride and other 1-deoxygalactose nojirimycin compounds. 提供了生产活性药物成分(API)级盐酸米加司他的方法,以及用于纯化中间体级盐酸米加司他的方法。进一步提供了生产盐酸[(2R,3S,4R,5S)-1-丁基-2-(羟甲基)哌啶-3,4,5-三醇(盐酸卢卡司他)和其他1-脱氧半乳糖野尻霉素化合物的方法,以及纯化中间体级盐酸卢卡司他和其他1-脱氧半乳糖野尻霉素化合物的方法。