tacrolimus monohydrate and its Impurities
A monohydrate salt of Tacrolimus, which is a macrolide lactone, used as an immunosupressant drug. Tacrolimus is a macrolide calcineurin inhibitor used mainly after allogeneic organ transplant to lower the risk of organ rejection. Topical ointment is used to treat severe cases of atopic dermatitis (eczema)Reference standards of Tacrolimus Monohydrate API,and its pharmacopeial, non pharmacopeial impurities, and stable isotopes are listed below.
Tacrolimus - Impurity D
(1R,9S,12S,13R,14S,17S,18E,21S,23S,24R,25S,27R)-1,14-Dihydroxy-12-[(1E)-1-[(1R,3R,4R)-4-hydroxy-3-methoxycyclohexyl]prop-1-en-2-yl]-23,25-dimethoxy-13,19,21,27-tetramethyl-17-(prop-2-en-1-yl)-11,28-dioxa-4-azatricyclo[22.3.1.04,9]octacos-18-ene-2,3,10,16-tetrone
Catalogue No.:PA 20 01040
CAS :
129212-35-7
Molecular Formula : C44H69NO12
Molecular Weight : 804.02
Tacrolimus Monohydrate - Impurity E
(1R,9S,12S,13R,14S,17R,18E,21S,23S,24R,25S,27R)-1,14-dihydroxy-12-[(1E)-1-[(1R, 3R,4R)-4-hydroxy-3-methoxycyclohexyl]prop-1-en-2-yl]-23,25-dimethoxy-13,19,21,27- tetramethyl-17-propyl-11,28-dioxa-4-azatricyclo[22.3.1.04,9]octacos-18-ene-2,3,10,16-tetrone
Catalogue No.:PA 20 01510
CAS :
104987-30-6
Molecular Formula : C44H71NO12
Molecular Weight : 806.03
Tacrolimus Monohydrate - Impurity H
(1E,3S,4R,5S,8R,9E,12S,14S)-5-Hydroxy-1-[(1R,3R,4R)-4-hydroxy-3-methoxycyclohexyl]-14-methoxy-14-[(2R,3S,5R)-3-methoxy-5-methyl-6-oxooxan-2-yl]-2,4,10,12-tetramethyl-7-oxo-8-(prop-2-en-1-yl)tetradeca-1,9-dien-3-yl(2S)-1-formylpiperidine-2-carboxylate
Catalogue No.:PA 20 01700
CAS :
143210-33-7
Molecular Formula : C43H69NO11
Molecular Weight : 776.02
Tacrolimus monohydrate - Impurity B
(1S,9S,12S,13R,14S,17R,18E,21S,23S,24R,25S,27R)-17-Ethyl-1,14-dihydroxy-12-[(1E)-1-[(1R,3R,4R)-4-hydroxy-3-methoxycyclohexyl]prop-1-en-2-yl]-23,25-dimethoxy13,19,21,27-tetramethyl-11,28-dioxa-4-azatricyclo[22.3.1.04,9]octacos-18-ene-2,3,10,16-tetrone,
Catalogue No.:PA 20 0010020
CAS :
NA
Molecular Formula : C43H69NO12
Molecular Weight : 792.02
Tacrolimus Monohydrate - Impurity F
(3S,4R,5S,8R,9E,12S,14S,15R,16S,18R,19R,26aS)-5,15-Dihydroxy-3-[(1E)-1-[(1R,3R,4R)-4-hydroxy-3-methoxycyclohexyl]prop-1-en-2-yl]-14,16-dimethoxy-4,10,12,18-tetramethyl-8-(prop-2-en-1-yl)-3,4,5,6,11,12,13,14,15,16,17,18,24,25,26,26a- hexadecahydro-7H-pyrido[2,1-c][1,4]oxaazacyclotricosine-1,7,19,20,21(8H,23H)-pentone
Catalogue No.:PA 20 0010060
CAS :
1393890-33-9
Molecular Formula : C44H69NO12
Molecular Weight : 804.03
Tacrolimus Monohydrate - Impurity C
(1R,9S,12S,13R,14S,17R,18E,21S,23S,24R,25S,27R)-1,14-Dihydroxy-12-[(1E)-1-[(1R,3R,4R)-4-hydroxy-3-methoxycyclohexyl]prop-1-en-2-yl]-23,25-dimethoxy-13,21,27-trimethyl-17-(prop-2-en-1-yl)-11,28-dioxa-4-azatricyclo[22.3.1.04,9]octacos-18-ene-2,3,10,16-tetrone
Catalogue No.:PA 20 0010030
CAS :
NA
Molecular Formula : C43H67NO12
Molecular Weight : 790
