Tezacaftor is used to treat cystic fibrosis in certain people. It is a drug that is sold as a fixed-dose combination with ivacaftor as Symdeko.Reference standards of Tezacaftor API, and its pharmacopeial, non pharmacopeial impurities, and stable isotopes are listed below.
Tezacaftor
Catalogue No.:PA 47 98000
CAS :
Molecular Formula : C26H27F3N2O6
Molecular Weight : 520.51
1-(2,2-Difluorobenzo[d][1,3]dioxol-5-yl)-N-(8-fluoro-2-hydroxy-4-(hydroxymethyl)-1,1-dimethyl-1,2,4,5-tetrahydro-[1,4]oxazepino[4,5-a]indol-9-yl)cyclopropane-1-carboxamide
Catalogue No.:PA 47 0981000
Molecular Formula : C26H25F3N2O6
Molecular Weight : 518.49
(R)-1-(5-Amino-2-(1-(benzyloxy)-2-methylpropan-2-yl)-6-fluoro-1H-indol-1-yl)-3-(benzyloxy)propan-2-ol
Catalogue No.:PA 47 0981001
Molecular Formula : C29H33FN2O3
Molecular Weight : 476.59
(R)-1-(2,2-Difluorobenzo[d][1,3]dioxol-5-yl)-N-(1-((2,2-dimethyl-1,3-dioxolan-4-yl)methyl)-6-fluoro-2-(1-hydroxy-2-methylpropan-2-yl)-1H-indol-5-yl)cyclopropane-1-carboxamide
Catalogue No.:PA 47 0981002
Molecular Formula : C29H31F3N2O6
Molecular Weight : 560.57
Tezacaftor Metabolite
Catalogue No.:PA 47 0981003
(R)-1-(Benzyloxy)-3-((2-bromo-5-fluoro-4-nitrophenyl)amino)propan-2-ol
Catalogue No.:PAI 47 098001
Molecular Formula : C16H16BrFN2O4
Molecular Weight : 399.22
(R)-1-((4-Amino-2-bromo-5-fluorophenyl)amino)-3-(benzyloxy)propan-2-ol
Catalogue No.:PAI 47 098002
Molecular Formula : C16H18BrFN2O2
Molecular Weight : 369.23
(R)-1-((4-Amino-2-(4-(benzyloxy)-3,3-dimethylbut-1-yn-1-yl)-5-fluorophenyl)amino)-3-(benzyloxy)propan-2-ol
Catalogue No.:PAI 47 098003
(R)-N-(1-(3-(Benzyloxy)-2-hydroxypropyl)-2-(1-(benzyloxy)-2-methylpropan-2-yl)-6-fluoro-1H-indol-5-yl)-1-(2,2-difluorobenzo[d][1,3]dioxol-5-yl)cyclopropane-1-carboxamide
Catalogue No.:PAI 47 098004
Molecular Formula : C40H39F3N2O6
Molecular Weight : 700.76
Tezacaftor D4
Catalogue No.:PA STI 089673
Molecular Formula : C26H23D4F3N2O6
Molecular Weight : 524.53
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