HIGHLY PURIFIED BATCHES OF PHARMACEUTICAL GRADE 1-DEOXYGALACTONOJIRIMYCIN COMPOUNDS

Provided are methods of producing a batch of 1,2,3,6-tetrapivaloyl-D-galactofuranoside; 5-azido-5-deoxy-1,2,3,6-tetrapivaloyl-D-galactofuranoside; intermediate grade migalastat hydrochloride; and/or migalastat hydrochloride. Also provided are methods of determining the purity of a batch of 1,2,3,6-t...

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Bibliographische Detailangaben
Hauptverfasser:	TESLER, Sergey, SHETH, Kamlesh
Format:	Patent
Sprache:	eng ; fre ; ger
Schlagworte:	CHEMISTRY HETEROCYCLIC COMPOUNDS METALLURGY ORGANIC CHEMISTRY PERFORMING OPERATIONS PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL SEPARATION TRANSPORTING
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Beschreibung
Zusammenfassung:	Provided are methods of producing a batch of 1,2,3,6-tetrapivaloyl-D-galactofuranoside; 5-azido-5-deoxy-1,2,3,6-tetrapivaloyl-D-galactofuranoside; intermediate grade migalastat hydrochloride; and/or migalastat hydrochloride. Also provided are methods of determining the purity of a batch of 1,2,3,6-tetrapivaloyl-D-galactofuranoside; 5-azido-5-deoxy-1,2,3,6-tetrapivaloyl-D-galactofuranoside; intermediate grade migalastat hydrochloride; and/or migalastat hydrochloride. Also provided are methods of distributing a batch of 1,2,3,6-tetrapivaloyl-D-galactofuranoside; 5-azido-5-deoxy-1,2,3,6-tetrapivaloyl-D-galactofuranoside; intermediate grade migalastat hydrochloride; and/or migalastat hydrochloride. Also provided are methods of assessing suitability of migalastat hydrochloride for medical use.