vinorelbine ditartrate and its Impurities
Vinorelbine Ditartrate is used off-label for other cancers such as metastatic breast cancer. It is also active in rhabdomyosarcoma. It is sold under the brand name Navelbine.Reference standards of Vinorelbine Ditartrate API,and its pharmacopeial, non pharmacopeial impurities, and stable isotopes are listed below.


Vinorelbine Ditartrate - Impurity B
Methyl (3aR,4R,5S,5aR,10bR,13aR)-3a-ethyl-9-[(6R,8S)-4-ethyl-8-(methoxycarbonyl)-1,3,6,7,8,9-hexahydro-2,6-methano-2H-azacyclodecino[4,3-b]indol-8-yl]-4,5-dihydroxy-8-methoxy-6-methyl-3a,4,5,5a,6,11,12,13a-octahydro-1H-indolizino[8,1-cd]carbazole-5-carboxylate
Catalogue No.:PA 22 30020
CAS :
126347-74-8
Molecular Formula : C43H52N4O7
Molecular Weight : 736.91


Vinorelbine Ditartrate - Impurity C
Methyl (3aR,4R,5S,5aR,10bR,13aR)-4-(acetyloxy)-3a-ethyl-9-[(6R,8R)-4-ethyl-8- (methoxycarbonyl)-1,3,6,7,8,9-hexahydro-2,6-methano-2H-azacyclodecino[4,3-b]indol-8-yl]-5-hydroxy-8-methoxy-6-methyl-3a,4,5,5a,6,11,12,13a-octahydro-1H- indolizino[8,1-cd]carbazole-5-carboxylate
Catalogue No.:PA 22 30030
CAS :
NA
Molecular Formula : C45H54N4O8
Molecular Weight : 778.93


Vinorelbine Ditartrate - Impurity H
(3aR,4R,5S,5aR,10bR,13aR)-4-(Acetyloxy)-3a-ethyl-9-[(6R,8S)-4-ethyl-8-(methoxycarbonyl)-1,3,6,7,8,9-hexahydro-2,6-methano-2H-azacyclodecino[4,3-b]indol-8-yl]-5-hydroxy-8-methoxy-6-methyl-3a,4,5,5a,6,11,12,13a-octahydro-1H-indolizino[8,1-cd]carbazole-5-carboxylic Acid
Catalogue No.:PA 22 30080
CAS :
220137-33-7
Molecular Formula : C44H52N4O8
Molecular Weight : 764.91


Vinorelbine Ditartrate - Impurity I
Methyl (3aR,4R,5S,5aR,10bR,13aR)-4- (acetyloxy)-7-bromo-3a-ethyl-9-[(6R,8S)-4-ethyl-8-(methoxycarbonyl)-1,3,6,7,8,9- hexahydro-2,6-methano-2H-azacyclodecino[4,3-b]indol-8-yl]-5-hydroxy-8-methoxy-6-methyl-3a,4,5,5a,6,11,12,13a-octahydro-1H-indolizino[8,1-cd]carbazole-5- carboxylate
Catalogue No.:PA 22 30090
CAS :
NA
Molecular Formula : C45H53BrN4O8
Molecular Weight : 857.83


Vinorelbine Ditartrate - Impurity K
Methyl (3aR,4R,5S,5aR,10bR,13aR)-4-(acetyloxy)-3a-ethyl-9-[(4RS,6S,8S)-4-ethyl-8- (methoxycarbonyl)-1,3,4,5,6,7,8,9-octahydro-2,6-methano-2H-azacyclodecino[4,3-b]indol- 8-yl]-5-hydroxy-8-methoxy-6-methyl-3a,4,5,5a,6,11,12,13a-octahydro-1H-indolizino[8,1- cd]carbazole-5-carboxylate
Catalogue No.:PA 22 30110
CAS :
NA
Molecular Formula : C45H56N4O8
Molecular Weight : 780.95


Vinorelbine Ditartrate - Impurity B (Ditartrate Salt)
Methyl (3aR,4R,5S,5aR,10bR,13aR)-3a-Ethyl-9-[(6R,8S)-4-ethyl-8-(methoxycarbonyl)1,3,6,7,8,9-hexahydro-2,6-methano-2H-azacyclodecino[4,3-b]indol-8-yl]-4,5-dihydroxy-8-methoxy-6-methyl-3a,4,5,5a,6,11,12,13a-octahydro-1Hindolizino[8,1-cd]carbazole-5-carboxylate Ditartrate
Catalogue No.:PA 22 30021
CAS :
NA
Molecular Formula : C51H64N4O19
Molecular Weight : 1037.08