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Bisoprolol Fumarate

Human API

Characterised impurities

ImpurityChemical namePharmacopoeia
Impurity A(2RS)-1-(4- hydroxymethyl- phenoxy)-3- isopropyl aminopropan-2-ol(EP)
Impurity L4-[(2RS)-2-hydroxy- (isopropylamino)pro pyl] oxy]benzaldehyde(EP)
Impurity N1-(4-((2- ethoxyethoxy)methy l)phenoxy)-3- isopropyl amino)propan-2-ol hydrochloride(EP)
Impurity “S”hydroxybenzaldehydBP/EP
Impurity T4-((3-isopropyl-2- oxooxazolidin-5- yl)methoxy)benzalde hyde(EP)
Impurity U Chlorhydri5-((4- (hydroxymethyl)phe noxy)methyl)-3- isopropyloxazolidine -2-one 1-chloro-3-(4-{[2- (propan-2- yloxy)ethoxy](EP) IHT
ne Epoxide compoundmethyl} phenoxy)propan-2-ol 2-({4-[(2-isopropoxy ethoxy)methyl]phen oxy}methyl oxiraneIHT
Isopropox y ester2-Isopropoxyethyl-4- hydroxybenzoateIHT
Epoxide ester2-Isopropoxyethyl-4- (2,3- Epoxypropoxy)benzo ateIHT
Impurity “K” 4- Hydroxybe2-isopropoxyethyl-4- [[(2RS)-2-hydroxy-3- (isopropylamino)pro pyl]oxy]benzoate 4-hydroxyIHT IHT
nzyl alcohol Impurity "Q"methlphenol (2RS)-1- (isopropylamino)-3- [4-(2- methoxyethoxy)met hyl] phenoxypropan- 2-ol fumarateEP
Impurity "R" N-Formyl compound(2RS)-1- (isopropylamino)-3- methylphenoxy)prop an-2-ol fumarate N-(2-Hydroxy-3-(4- ((2- isopropoxyethoxy)m ethyl)phenoxy) propyl)-N- isopropylformamideEP IHT
Impurity “A”{5-[(E)-(4- Carboxyphenyl)diaze nyl]-2- hydroxybenzoic acid}IHT

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