HIGHLY PURIFIED BATCHES OF PHARMACEUTICAL GRADE 1-DEOXYGALACTONOJIRIMYCIN COMPOUNDS

Provided are methods of producing Active Pharmaceutical Ingredient (API) grade migalastat hydrochloride, and 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 (lucerastat h...

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Bibliographische Detailangaben
Hauptverfasser: TESLER, SERGEY, SHETH, KAMLESH
Format: Patent
Sprache:eng ; fre
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Zusammenfassung:Provided are methods of producing Active Pharmaceutical Ingredient (API) grade migalastat hydrochloride, and 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 (lucerastat hydrochloride) and other 1-deoxygalactonojirimycin compounds, as well as methods of purifying intermediate grade lucerastat hydrochloride and other 1-deoxygalactonojirimycin compounds. L'invention concerne des procédés de production de chlorhydrate de migalastat de qualité ingrédient pharmaceutique actif (API), et de purification de chlorhydrate de migalastat de qualité intermédiaire. L'invention concerne en outre des procédés de production de chlorhydrate de [(2R,3S,4R,5S)-1-butyl-2-(hydroxyméthyl)pipéridine-3,4,5-triol (chlorhydrate de lucérastat) et d'autres composés de 1-désoxygalactonojirimycine, ainsi que des procédés de purification de chlorhydrate de lucérastat de qualité intermédiaire et d'autres composés de 1-désoxygalactonojirimycine.