Pharmaceutical Impurity Reference Standards

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Structure Chemical Name CAS MF
Amylmetacresol EP impurity E Amylmetacresol EP impurity E
(2S)-2-(2,5-dioxo-3-propylpyrrolidin-1-yl)butanamide (2S)-2-(2,5-dioxo-3-propylpyrrolidin-1-yl)butanamide 2232201-72-6 C11H18N2O3
methyl 1-hydroxy-2-oxoindoline-6-carboxylate methyl 1-hydroxy-2-oxoindoline-6-carboxylate 1895918-24-7 C10H9NO4
Dapagliflozin Impurity (MW: 437Da) Dapagliflozin Impurity (MW: 437Da)
Cetirizine Impurity BHA Cetirizine Impurity BHA
Macitentandesbromopyrimidine Impurity Macitentandesbromopyrimidine Impurity
Cilastatin EP Impurity H Cilastatin EP Impurity H
Febuxostat Impurity 130 Febuxostat Impurity 130 1643131-93-4 C20H25NO5S
(2-Chlorophenyl)diphenylmethanol (2-Chlorophenyl)diphenylmethanol
Nilotinib Impurity 27 Nilotinib Impurity 27 1807606-80-9 C28H22F3N7O2
Vonoprazan Impurity 53 Vonoprazan Impurity 53
Vonoprazan Impurity 61 Vonoprazan Impurity 61
Emtricitabine Ring-opening Impurity Emtricitabine Ring-opening Impurity
Tafluprost Impurity 1 (Tafluprost (1S,2S,3S,5R)-Isomer) Tafluprost Impurity 1 (Tafluprost (1S,2S,3S,5R)-Isomer)
Escitalopram Butyryl Impurity Escitalopram Butyryl Impurity 1803244-58-7 C25H33FN2O2
Oseltamivir isomer impurity Oseltamivir isomer impurity
Ethyl 4-bromo-3-hydroxybutyrate Ethyl 4-bromo-3-hydroxybutyrate 32224-01-4 C6H11BrO3
(2R,4S)-Isopropyl 5-([1,1''-biphenyl]-4-yl)-4-(4-isopropoxy-4-oxobutanamido)-2-methylpentanoate (2R,4S)-Isopropyl 5-([1,1''-biphenyl]-4-yl)-4-(4-isopropoxy-4-oxobutanamido)-2-methylpentanoate 2216755-67-6 C28H37NO5
1,2-Dihydro Diethyl Loteprednol Carbonate 1,2-Dihydro Diethyl Loteprednol Carbonate 82048-81-5 C26H36O9
Nilotinib 3-Imidazolyl N-oxide Nilotinib 3-Imidazolyl N-oxide 2139382-75-3 C28H22F3N7O2
α,α''-[(Methylimino)di-2,1-ethanediyl]bis-benzenemethanol α,α''-[(Methylimino)di-2,1-ethanediyl]bis-benzenemethanol 857786-66-4 C19H25NO2
sodium 5-methoxy-2-sulfinatobenzo[d]imidazol-1-id sodium 5-methoxy-2-sulfinatobenzo[d]imidazol-1-id
Pramipexole 828 Impurity Pramipexole 828 Impurity
E-Ceftazidime Oxide Impurity E-Ceftazidime Oxide Impurity
Cefuroxime Impurity D Δ3-Isomer Cefuroxime Impurity D Δ3-Isomer
Ampicillin Open-Ring Formylation Impurity Ampicillin Open-Ring Formylation Impurity
Faropenem Degradation Impurity A Faropenem Degradation Impurity A
2-(5-hydroxy-5H-chromeno[2,3-b]pyridin-7-yl)propanoic acid 2-(5-hydroxy-5H-chromeno[2,3-b]pyridin-7-yl)propanoic acid
Eribulin Impurity 2 Eribulin Impurity 2
(2S)-dimethyl 2-(4-(4-oxobutan-2-yl)benzamido)pentanedioate (2S)-dimethyl 2-(4-(4-oxobutan-2-yl)benzamido)pentanedioate
(E)-1-(2,4-difluorostyryl)-1H-1,2,4-triazole (E)-1-(2,4-difluorostyryl)-1H-1,2,4-triazole
Peramivir Impurity 22 Peramivir Impurity 22
Olaparib Impurity 58 Olaparib Impurity 58 848136-41-4 C22H21FN4O3
Fluconazole Impurity 4 Fluconazole Impurity 4 168479-96-7 C10H7F2N3O
Roxatidine Impurity 7 Roxatidine Impurity 7 876497-65-3 C7H6N2O2
Sparfloxacin Impurity Sparfloxacin Impurity 126457-99-6 C19H21F2N3O3
Peramivir Impurity 39 Peramivir Impurity 39
Imatinib impurity 39 Imatinib impurity 39
7-(4-BROMOBUTOXY)-QUINOLINE-2(1H)-ONE 7-(4-BROMOBUTOXY)-QUINOLINE-2(1H)-ONE 203395-59-9 C13H14BrNO2
DESMETHYL ATOMOXETINE HYDROCHLORIDE DESMETHYL ATOMOXETINE HYDROCHLORIDE 881995-46-6 C16H19NO.ClH
2-HYDROXY-5-BENZYLOXYACETOPHENONE 2-HYDROXY-5-BENZYLOXYACETOPHENONE 30992-63-3 C15H14O3
2-[(4-METHOXY-3-METHYL-2-PYRIDINYL)-METHYLTHIO]-BENZIMIDAZOLE 2-[(4-METHOXY-3-METHYL-2-PYRIDINYL)-METHYLTHIO]-BENZIMIDAZOLE 102804-82-0 C15H15N3OS
2-[(4-METHYLPIPERAZIN-1-YL)METHYL]BENZONITRILE 2-[(4-METHYLPIPERAZIN-1-YL)METHYL]BENZONITRILE 864069-00-1 C13H17N3
Afatinib impurity 84 Afatinib impurity 84
Sugammadex sodium Impurity 40 Sugammadex sodium Impurity 40
Sugammadex sodium Impurity 44 Sugammadex sodium Impurity 44
Sugammadex sodium Impurity 49 Sugammadex sodium Impurity 49
Cefazolin Impurity EP-E Cefazolin Impurity EP-E
Canagliflozin Impurity 70 Canagliflozin Impurity 70
Dapoxetine impurity 66 Dapoxetine impurity 66
EP Impurity Catalog EP Impurity Catalog
2-[(5-CARBOXY-4-METHOXY-3-METHYLPYRID-2-YL)-METHYLSULFO]-5-METHOXYBENZIMIDAZOLE 2-[(5-CARBOXY-4-METHOXY-3-METHYLPYRID-2-YL)-METHYLSULFO]-5-METHOXYBENZIMIDAZOLE 120003-72-7 C17H17N3O5S
Gadobutrol Impurity 3 Gadobutrol Impurity 3
Empagliflozin Impurity 84 Empagliflozin Impurity 84
Iohexol Impurity O Iohexol Impurity O
Avibactam sodium Impurity CES Avibactam sodium Impurity CES
(2,5-dichlorophenyl)(4-ethoxyphenyl)methanone (2,5-dichlorophenyl)(4-ethoxyphenyl)methanone 1097076-93-1 C15H12Cl2O2
Lenvatinib impurity LFZZ-10 Lenvatinib impurity LFZZ-10 C11H8Cl2N2O2
(2S,5S)-(1R,2S,5R)-2-isopropyl-5-methylcyclohexyl 5-(4-amino-2-oxopyrimidin-1(2H)-yl)-1,3-oxathiolane-2-carboxylate (2S,5S)-(1R,2S,5R)-2-isopropyl-5-methylcyclohexyl 5-(4-amino-2-oxopyrimidin-1(2H)-yl)-1,3-oxathiolane-2-carboxylate
Febuxostat Impurity 98 Febuxostat Impurity 98
(2-(methyl((vinyloxy)carbonyl)amino)pyridin-3-yl)methyl 2-(methylamino)acetate hydrochloride (2-(methyl((vinyloxy)carbonyl)amino)pyridin-3-yl)methyl 2-(methylamino)acetate hydrochloride
1-(4-bromo-3,5-dimethoxyphenyl)ethanone 1-(4-bromo-3,5-dimethoxyphenyl)ethanone 1333472-28-8 C10H11BrO3
Ticagrelor Impurity 117 Ticagrelor Impurity 117
Ticagrelor Impurity 136 Ticagrelor Impurity 136
Phenol, 2-(diphenylmethyl)-5-methyl- Phenol, 2-(diphenylmethyl)-5-methyl- 411239-19-5 C20H18O
1-Cyclohexene-1-carboxylic acid, 4-(acetylamino)-3-(1-ethylpropoxy)-5-(formylamino)-, ethyl ester, (3R,4R,5S)- 1-Cyclohexene-1-carboxylic acid, 4-(acetylamino)-3-(1-ethylpropoxy)-5-(formylamino)-, ethyl ester, (3R,4R,5S)- 2148317-96-6 C17H28N2O5
Imidazo[5,1-f][1,2,4]triazin-4(1H)-one, 2-(5-chloro-2-ethoxyphenyl)-5-methyl-7-propyl- Imidazo[5,1-f][1,2,4]triazin-4(1H)-one, 2-(5-chloro-2-ethoxyphenyl)-5-methyl-7-propyl- 2245167-80-8 C17H19ClN4O2
Posaconazole impurity 18 Posaconazole impurity 18 1819334-66-1 C44H49F2N8O4+
(4S,6R)-6-(2-(tert-butoxy)-2-oxoethyl)-2,2-dimethyl-1,3-dioxane-4-carboxylic acid (4S,6R)-6-(2-(tert-butoxy)-2-oxoethyl)-2,2-dimethyl-1,3-dioxane-4-carboxylic acid 2095786-11-9 C13H22O6
Crisaborole intermediate Crisaborole intermediate 2354382-27-5 C14H8BCl2NO3
Ropivacaine Impurity 48 Ropivacaine Impurity 48
2,4-Heptadienoic acid, 7-[2-(4-fluorophenyl)-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrol-1-yl]-, (2Z,4E)- 2,4-Heptadienoic acid, 7-[2-(4-fluorophenyl)-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrol-1-yl]-, (2Z,4E)- 1148131-09-2 C33H31FN2O3
2(3H)-Furanone, dihydro-4-(1-methylethyl)-, (4S)- 2(3H)-Furanone, dihydro-4-(1-methylethyl)-, (4S)- 53657-15-1 C7H12O2
Crisaborole Impurity 9 HCl Crisaborole Impurity 9 HCl 1187187-01-4 C14H15BClNO3
2H-Indol-2-one, 3-[[3,5-dimethyl-4-(1-pyrrolidinylcarbonyl)-1H-pyrrol-2-yl]methylene]-5-fluoro-1,3-dihydro- 2H-Indol-2-one, 3-[[3,5-dimethyl-4-(1-pyrrolidinylcarbonyl)-1H-pyrrol-2-yl]methylene]-5-fluoro-1,3-dihydro- 2135339-43-2 C20H20FN3O2
Nicergoline Impurity 02 Nicergoline Impurity 02
Bromhexine ImpurityABCDEFGHJKL Bromhexine ImpurityABCDEFGHJKL
1-Butanone, 1-(4-fluorophenyl)-4-[(6bR,10aR)-2,3,6b,9,10,10a-hexahydro-3-methyl-1H-pyrido[3',4':4,5]pyrrolo[1,2,3-de]quinoxalin-8(7H)-yl]- 1-Butanone, 1-(4-fluorophenyl)-4-[(6bR,10aR)-2,3,6b,9,10,10a-hexahydro-3-methyl-1H-pyrido[3',4':4,5]pyrrolo[1,2,3-de]quinoxalin-8(7H)-yl]- 1576240-16-8 C24H28FN3O
impurity 37 impurity 37
Aprepitant impurity 3 Aprepitant impurity 3
sodium (6R,7S)-7-(2-(1H-tetrazol-1-yl)acetamido)-3-(((5-methyl- 1,3,4-thiadiazol-2-yl)thio)methyl)-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate sodium (6R,7S)-7-(2-(1H-tetrazol-1-yl)acetamido)-3-(((5-methyl- 1,3,4-thiadiazol-2-yl)thio)methyl)-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate
1,4,7,10-Tetraazacyclododecane-1,4-diacetic acid 1,4,7,10-Tetraazacyclododecane-1,4-diacetic acid 229312-34-9 C12H24N4O4
Pentanoic acid, 3-(bromomethyl)-4-methyl-, ethyl ester, (3S)- Pentanoic acid, 3-(bromomethyl)-4-methyl-, ethyl ester, (3S)- 2432911-38-9 C9H17BrO2
Imidazo[5,1-f][1,2,4]triazin-4(1H)-one, 2-[5-[(4-ethyl-1-piperazinyl)sulfonyl]-2-hydroxyphenyl]-5-methyl-7-propyl- Imidazo[5,1-f][1,2,4]triazin-4(1H)-one, 2-[5-[(4-ethyl-1-piperazinyl)sulfonyl]-2-hydroxyphenyl]-5-methyl-7-propyl- 2411340-39-9 C21H28N6O4S
3-Azetidineacetonitrile, 1-(ethylsulfonyl)-3-[4-[7-(hydroxymethyl)-7H-pyrrolo[2,3-d]pyrimidin-4-yl]-1H-pyrazol-1-yl]- 3-Azetidineacetonitrile, 1-(ethylsulfonyl)-3-[4-[7-(hydroxymethyl)-7H-pyrrolo[2,3-d]pyrimidin-4-yl]-1H-pyrazol-1-yl]- 1187595-89-6 C17H19N7O3S
4-methyl-N-(2-(methylamino)phenyl)-2-propyl-1H-benzo[d]imidazole-6-carboxamide 4-methyl-N-(2-(methylamino)phenyl)-2-propyl-1H-benzo[d]imidazole-6-carboxamide 884330-18-1 C19H22N4O
Benzeneacetic acid, 3-(2-amino-1,1-dimethyl-2-oxoethyl)-α,α-dimethyl-5-(1H-1,2,4-triazol-1-ylmethyl)- Benzeneacetic acid, 3-(2-amino-1,1-dimethyl-2-oxoethyl)-α,α-dimethyl-5-(1H-1,2,4-triazol-1-ylmethyl)- 2469244-33-3 C17H22N4O3
2,4(1H,3H)-Pyrimidinedione, 5-(2-fluoro-3-methoxyphenyl)-1-[[2-fluoro-6-(trifluoromethyl)phenyl]methyl]-3-[(2R)-2-(hydroxyamino)-2-phenylethyl]-6-methyl- 2,4(1H,3H)-Pyrimidinedione, 5-(2-fluoro-3-methoxyphenyl)-1-[[2-fluoro-6-(trifluoromethyl)phenyl]methyl]-3-[(2R)-2-(hydroxyamino)-2-phenylethyl]-6-methyl- 2486454-64-0 C28H24F5N3O4
3-Quinolinecarbonitrile, 4-[(2,4-dichloro-5-hydroxyphenyl)amino]-6-hydroxy-7-[3-(4-methyl-1-piperazinyl)propoxy]- 3-Quinolinecarbonitrile, 4-[(2,4-dichloro-5-hydroxyphenyl)amino]-6-hydroxy-7-[3-(4-methyl-1-piperazinyl)propoxy]- 2468737-94-0 C24H25Cl2N5O3
1H-Pyrido[3',4':4,5]pyrrolo[1,2,3-de]quinoxaline, 2,3,6b,7,8,9,10,10a-octahydro-, (6bR,10aS)- 1H-Pyrido[3',4':4,5]pyrrolo[1,2,3-de]quinoxaline, 2,3,6b,7,8,9,10,10a-octahydro-, (6bR,10aS)- 313368-81-9 C13H17N3
Ergoline-8-methanol, 1,6-dimethyl-, (8β)- (9CI) Ergoline-8-methanol, 1,6-dimethyl-, (8β)- (9CI) 40170-12-5 C17H22N2O
Avatrombopag Impurity 22 Avatrombopag Impurity 22
Avatrombopag Impurity 33 Avatrombopag Impurity 33
Cisatracurium besylate impurity 16 Cisatracurium besylate impurity 16
1-ACETYL-2-METHYLBENZIMIDAZOLE 1-ACETYL-2-METHYLBENZIMIDAZOLE 14678-81-0 C10H10N2O
(E)-3-(2-Formylphenyl)-2-propenoic acid 1,1-dimethyl ethyl ester (E)-3-(2-Formylphenyl)-2-propenoic acid 1,1-dimethyl ethyl ester 103890-69-3 C14H16O3
1H-Dibenz[e,g]indole-1-heptanoic acid, 9-fluoro-2,3-dihydro-β,δ-dihydroxy-3-(1-methylethyl)-2-oxo-3-[(phenylamino)carbonyl]-, (βR,δR)- 1H-Dibenz[e,g]indole-1-heptanoic acid, 9-fluoro-2,3-dihydro-β,δ-dihydroxy-3-(1-methylethyl)-2-oxo-3-[(phenylamino)carbonyl]-, (βR,δR)- 1046533-62-3 C33H33FN2O6
Bimatoprost Impurity 22 Bimatoprost Impurity 22
Bumetanide Impurity 9 Bumetanide Impurity 9
Crisaborole Impurity 14 Crisaborole Impurity 14
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