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Pharmaceutical Impurity Reference Standards

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Structure Chemical Name CAS MF
Doxofylline Impurity 22 Doxofylline Impurity 22
Dapoxetine impurity 61 Dapoxetine impurity 61
Dapoxetine impurity 55 Dapoxetine impurity 55
1-METHYLBIGUANIDE SULPHATE 1-METHYLBIGUANIDE SULPHATE 1609-00-3 C3H9N5
1-(3,5-DIHYDROXYPHENYL)-2-[(1,1-DIMETHYLETHYL)AMINO]-ETHANONE, HYDROCHLORIDE 1-(3,5-DIHYDROXYPHENYL)-2-[(1,1-DIMETHYLETHYL)AMINO]-ETHANONE, HYDROCHLORIDE 1246815-70-2 C12H18ClNO3
4-(((2R,3S,4R,5R,6R)-6-(Benzyloxy)-3-((diphenoxyphosphoryl)oxy)-4-(tetradecanoyloxy)-5-((S)-3-(tetradecanoyloxy)tetradecanaMido)tetrahydro-2H-pyran-2-yl)Methoxy)-4-oxobutanoic acid 4-(((2R,3S,4R,5R,6R)-6-(Benzyloxy)-3-((diphenoxyphosphoryl)oxy)-4-(tetradecanoyloxy)-5-((S)-3-(tetradecanoyloxy)tetradecanaMido)tetrahydro-2H-pyran-2-yl)Methoxy)-4-oxobutanoic acid 110611-91-1 C71H110NO15P
2-[4-(2,3-EPOXYPROPOXY)PHENYL]ACETAMIDE 2-[4-(2,3-EPOXYPROPOXY)PHENYL]ACETAMIDE 29122-69-8 C11H13NO3
Oxacillin Impurity H Oxacillin Impurity H
(2S,3R)-3-(6-(1-(6-chloro-5-fluoropyrimidin-4-yl)ethyl)-5-fluoropyrimidin-4-yl)-2-(2,4-difluorophenyl)-1-(1H-1,2,4-triazol-1-yl)butan-2-ol (2S,3R)-3-(6-(1-(6-chloro-5-fluoropyrimidin-4-yl)ethyl)-5-fluoropyrimidin-4-yl)-2-(2,4-difluorophenyl)-1-(1H-1,2,4-triazol-1-yl)butan-2-ol
PeraMpanel PeraMpanel 380918-54-7 C23H15N3O
Empagliflozin Impurity 79 Empagliflozin Impurity 79
Empagliflozin Impurity 89 Empagliflozin Impurity 89 2452301-32-3 C23H25ClO7
Levocarnitine Impurity F Levocarnitine Impurity F 6490-19-3 C7H17ClN2O2
4,4-dimethyl-2-(2-phenylpropan-2-yl)oxazo‐ line 4,4-dimethyl-2-(2-phenylpropan-2-yl)oxazo‐ line 874895-87-1 C14H19NO
Formoterol Impurity 4 Formoterol Impurity 4
Roxadustat-001 Roxadustat-001 319-57-3 C8H5BF4N2O2
Ornidazole Impurity 24 Ornidazole Impurity 24
Olanzapine impurity ANB Olanzapine impurity ANB
Pitavastatin Impurity 75 Pitavastatin Impurity 75
Febuxostat Impurity 100 Febuxostat Impurity 100
Febuxostat Impurity 101 Febuxostat Impurity 101
Febuxostat Impurity 105 Febuxostat Impurity 105
(S)-10-amino-9-fluoro-3-methyl-7-oxo-3,7-dihydro-2H-[1,4]oxazino[2,3,4-ij]quinoline-6-carboxylic acid (S)-10-amino-9-fluoro-3-methyl-7-oxo-3,7-dihydro-2H-[1,4]oxazino[2,3,4-ij]quinoline-6-carboxylic acid
Ticagrelor Impurity 129 Ticagrelor Impurity 129 1381841-36-6 C15H19NO3
Benzoic acid, 2-hydroxy-3-(2-phenyldiazenyl)- Benzoic acid, 2-hydroxy-3-(2-phenyldiazenyl)- 136819-59-5 C13H10N2O3
5-Thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid, 7-[[(2Z)-(2-amino-4-thiazolyl)(methoxyimino)acetyl]amino]-8-oxo-3-[[(1,2,5,6-tetrahydro-2-methyl-5,6-dioxo-1,2,4-triazin-3-yl)thio]methyl]-, 5-oxide, (6R,7R)- (9CI) 5-Thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid, 7-[[(2Z)-(2-amino-4-thiazolyl)(methoxyimino)acetyl]amino]-8-oxo-3-[[(1,2,5,6-tetrahydro-2-methyl-5,6-dioxo-1,2,4-triazin-3-yl)thio]methyl]-, 5-oxide, (6R,7R)- (9CI) 97466-28-9 C18H18N8O8S3
1,3-Benzenediamine, 4-methyl-N3-[4-methyl-6-(3-pyridinyl)-2-pyrimidinyl]- 1,3-Benzenediamine, 4-methyl-N3-[4-methyl-6-(3-pyridinyl)-2-pyrimidinyl]- 1032314-73-0 C17H17N5
5-methoxy-1-methyl-1H-benzo[d]imidazole-2-sulfonic acid 5-methoxy-1-methyl-1H-benzo[d]imidazole-2-sulfonic acid
Teneligliptin Impurity 17 Teneligliptin Impurity 17
1(3H)-Isobenzofuranone, 3-(1-methylpropyl)- 1(3H)-Isobenzofuranone, 3-(1-methylpropyl)- 261783-87-3 C12H14O2
(2S,5R)-2-carbamoyl-7-oxo-1,6-diazabicyclo[3.2.1]octan-6-yl methyl sulfate (2S,5R)-2-carbamoyl-7-oxo-1,6-diazabicyclo[3.2.1]octan-6-yl methyl sulfate
Carbamic acid, N-[(1R)-2-[5-(2-fluoro-3-hydroxyphenyl)-3-[[2-fluoro-6-(trifluoromethyl)phenyl]methyl]-3,6-dihydro-4-methyl-2,6-dioxo-1(2H)-pyrimidinyl]-1-phenylethyl]-, 1,1-dimethylethyl ester Carbamic acid, N-[(1R)-2-[5-(2-fluoro-3-hydroxyphenyl)-3-[[2-fluoro-6-(trifluoromethyl)phenyl]methyl]-3,6-dihydro-4-methyl-2,6-dioxo-1(2H)-pyrimidinyl]-1-phenylethyl]-, 1,1-dimethylethyl ester 1062642-68-5 C32H30F5N3O5
2-Oxazolidinone, 5-(2,2-dimethyl-4H-1,3-benzodioxin-6-yl)-, (5S)- 2-Oxazolidinone, 5-(2,2-dimethyl-4H-1,3-benzodioxin-6-yl)-, (5S)- 2514942-86-8 C13H15NO4
Heptanoic acid, 7-[[(3R,5R)-7-[2-(4-fluorophenyl)-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrol-1-yl]-3,5-dihydroxy-1-oxoheptyl]amino]-3,5-dihydroxy-, 1,1-dimethylethyl ester, (3R,5R)- Heptanoic acid, 7-[[(3R,5R)-7-[2-(4-fluorophenyl)-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrol-1-yl]-3,5-dihydroxy-1-oxoheptyl]amino]-3,5-dihydroxy-, 1,1-dimethylethyl ester, (3R,5R)- 2409556-65-4 C44H56FN3O8
6-Heptenoic acid, 7-[4-(4-fluorophenyl)-6-(1-methylethyl)-2-[methyl(methylsulfonyl)amino]-5-pyrimidinyl]-5-hydroxy-3-oxo-, (5S,6E)- 6-Heptenoic acid, 7-[4-(4-fluorophenyl)-6-(1-methylethyl)-2-[methyl(methylsulfonyl)amino]-5-pyrimidinyl]-5-hydroxy-3-oxo-, (5S,6E)- 1803023-43-9 C22H26FN3O6S
Drug impurity detection and analysis Drug impurity detection and analysis
1-Pyrrolidinecarboxamide, N-[5-[(2S)-2-(2,5-difluorophenyl)-1-pyrrolidinyl]pyrazolo[1,5-a]pyrimidin-3-yl]-3-hydroxy-, (3R)- 1-Pyrrolidinecarboxamide, N-[5-[(2S)-2-(2,5-difluorophenyl)-1-pyrrolidinyl]pyrazolo[1,5-a]pyrimidin-3-yl]-3-hydroxy-, (3R)- 2409590-08-3 C21H22F2N6O2
Sertraline Impurity 20 Sertraline Impurity 20 1498236-91-1 C16H14Cl2O
Budesonide Impurity 21 Budesonide Impurity 21
2H-3-Benzazepin-2-one, 3-(3-bromopropyl)-1,3,4,5-tetrahydro-7,8-dimethoxy- 2H-3-Benzazepin-2-one, 3-(3-bromopropyl)-1,3,4,5-tetrahydro-7,8-dimethoxy- 1192174-72-3 C15H20BrNO3
Benzamide, 2-[(1-acetyl-3-iodo-1H-indazol-6-yl)thio]-N-methyl- Benzamide, 2-[(1-acetyl-3-iodo-1H-indazol-6-yl)thio]-N-methyl- 1639138-00-3 C17H14IN3O2S
1-Cyclohexene-1-carboxylic acid, 4-(acetylamino)-3-(1-ethylpropoxy)-5-nitro-, ethyl ester, (3R,4R,5S)- 1-Cyclohexene-1-carboxylic acid, 4-(acetylamino)-3-(1-ethylpropoxy)-5-nitro-, ethyl ester, (3R,4R,5S)- 949164-64-1 C16H26N2O6
Peramivir Impurity 55 Peramivir Impurity 55
Peramivir Impurity 60 Peramivir Impurity 60
Hexanoic acid, 3-(hydroxymethyl)-, methyl ester, (3R)- Hexanoic acid, 3-(hydroxymethyl)-, methyl ester, (3R)- 2408196-94-9 C8H16O3
Loratadine EP Impurity L Loratadine EP Impurity L
Pregna-1,4-dien-3-one, 21-(acetyloxy)-11,17,20-trihydroxy-6-methyl-, (6α,11β)- (9CI) Pregna-1,4-dien-3-one, 21-(acetyloxy)-11,17,20-trihydroxy-6-methyl-, (6α,11β)- (9CI) 151003-82-6 C24H34O6
3-Pyridinecarboxamide, 5-chloro-N-[4-(4-chloro-2-thienyl)-5-(4-cyclohexyl-1-piperazinyl)-2-thiazolyl]-1,6-dihydro-6-oxo- 3-Pyridinecarboxamide, 5-chloro-N-[4-(4-chloro-2-thienyl)-5-(4-cyclohexyl-1-piperazinyl)-2-thiazolyl]-1,6-dihydro-6-oxo- 762237-66-1 C23H25Cl2N5O2S2
3-(4-TRIFLUOROMETHYL-PHENYL)-PROPAN-1-OL 3-(4-TRIFLUOROMETHYL-PHENYL)-PROPAN-1-OL 180635-74-9 C10H11F3O
Avatrombopag Impurity 39 Avatrombopag Impurity 39
(1R,2R)-2-(3-((5-acetoxypentyl)oxy)-3-oxopropyl)-1-(3,4-dimethoxybenzyl)-6,7-dimethoxy-2-methyl-1,2,3,4-tetrahydroisoquinolin-2-ium (1R,2R)-2-(3-((5-acetoxypentyl)oxy)-3-oxopropyl)-1-(3,4-dimethoxybenzyl)-6,7-dimethoxy-2-methyl-1,2,3,4-tetrahydroisoquinolin-2-ium
(E)-2-CYANO-5-METHYL-HEX-2-ENOIC ACID METHYL ESTER (E)-2-CYANO-5-METHYL-HEX-2-ENOIC ACID METHYL ESTER 96914-67-9 C9H13NO2
Nicergoline Impurity 7 Nicergoline Impurity 7
N,N'-Bis(2-Hydroxyethyl)propane-1,3-diamine N,N'-Bis(2-Hydroxyethyl)propane-1,3-diamine 10563-27-6 C7H18N2O2
1026009-77-7 1026009-77-7 1026009-77-7 C20H22N2O
α,α,α'',5-Tetramethyl-1,3-benzenediacetonitrile α,α,α'',5-Tetramethyl-1,3-benzenediacetonitrile 120512-38-1 C14H16N2
α,α,α'',5-Tetramethyl-1,3-benzenediacetonitrile α,α,α'',5-Tetramethyl-1,3-benzenediacetonitrile 120512-38-1 C14H16N2
Regorafenib Impurity MJ Regorafenib Impurity MJ
Aztreonam Open-Ring Desulfurization Impurity Aztreonam Open-Ring Desulfurization Impurity
Azlocillin dioxide Impurity Azlocillin dioxide Impurity
Azlocillin dioxide Impurity Azlocillin dioxide Impurity
7-(2-methoxypropanoyl)-5H-chromeno[2,3-b]pyridin-5-one 7-(2-methoxypropanoyl)-5H-chromeno[2,3-b]pyridin-5-one
Ibrutinib Impurity 42 Ibrutinib Impurity 42 2031255-24-8 C25H23N5O3
Pramipexole Impurity N Pramipexole Impurity N
Hydroxychloroquine Impurity 12 Hydrochloride Hydroxychloroquine Impurity 12 Hydrochloride 2411340-31-1 C18H26ClN3O
Verteporfin impurity Verteporfin impurity 121310-58-5 C40H40N4O8
Peramivir Impurity 25 Peramivir Impurity 25
Peramivir Impurity 33 Peramivir Impurity 33 2758048-78-9 C18H34N2O5
Imatinib impurity XT Imatinib impurity XT
4-((3-hydroxy-1H-indazol-5-yl)methyl)phthalazin-1(2H)-one 4-((3-hydroxy-1H-indazol-5-yl)methyl)phthalazin-1(2H)-one
2-oxo-2-((6S,8S,9S,10R,13S,14S,17S)-6,10,13-trimethyl-3,11-dioxo-6,7,8,9,10,11,12,13,14,15,16,17-dodecahydro-3H-cyclopenta[a]phenanthren-17-yl)ethyl acetate 2-oxo-2-((6S,8S,9S,10R,13S,14S,17S)-6,10,13-trimethyl-3,11-dioxo-6,7,8,9,10,11,12,13,14,15,16,17-dodecahydro-3H-cyclopenta[a]phenanthren-17-yl)ethyl acetate
Tirofiban Impurity 79 Tirofiban Impurity 79 158808-85-6 C21H34N2O5S
Brivaracetam Impurity 47 Brivaracetam Impurity 47 2755924-55-9
(Glu3)-Carbetocin (Impurity D) (Glu3)-Carbetocin (Impurity D)
4-((3-amino-1-(2-fluoro-5-((4-oxo-3,4-dihydrophthalazin-1-yl)methyl)benzoyl)-1H-indazol-5-yl)methyl)phthalazin-1(2H)-one 4-((3-amino-1-(2-fluoro-5-((4-oxo-3,4-dihydrophthalazin-1-yl)methyl)benzoyl)-1H-indazol-5-yl)methyl)phthalazin-1(2H)-one
(Z)-[cyano(2,3-dichlorophenyl)methylene]carbazamidine (Z)-[cyano(2,3-dichlorophenyl)methylene]carbazamidine 94213-23-7 C9H7Cl2N5
Perampanel Impurity ABCDEFGHJKL Perampanel Impurity ABCDEFGHJKL
ethyl 3-acetoxy-2-butenoate ethyl 3-acetoxy-2-butenoate 29214-62-8 C8H12O4
2-(bromomethyl)-2-(2,4-dichlorophenyl)-1,3-dioxolane-4-methanol 2-(bromomethyl)-2-(2,4-dichlorophenyl)-1,3-dioxolane-4-methanol 68751-57-5 C11H11BrCl2O3
INDEX NAME NOT YET ASSIGNED INDEX NAME NOT YET ASSIGNED 2511244-96-3 C27H36N2O6
Oseltamivir Impurity 91 Oseltamivir Impurity 91
Oseltamivir Impurity 80 Oseltamivir Impurity 80
Oseltamivir Impurity 72 Oseltamivir Impurity 72
4(1H)-Quinazolinone, 6,8-dibromo-3-cyclohexyl-2,3-dihydro- 4(1H)-Quinazolinone, 6,8-dibromo-3-cyclohexyl-2,3-dihydro- 2512203-87-9 C14H16Br2N2O
Linagliptin impurity KH-3 Linagliptin impurity KH-3 2279114-27-9 C30H37N7O6
11beta,21-dihydroxypregna-1,4,16-triene-3,20-dione 21-acetate 11beta,21-dihydroxypregna-1,4,16-triene-3,20-dione 21-acetate 3044-42-6 C23H28O5
3-[3-(tert-butylamino)-2-hydroxypropoxy]-4-morpholino-1,2,5-thiadiazole monomaleate 3-[3-(tert-butylamino)-2-hydroxypropoxy]-4-morpholino-1,2,5-thiadiazole monomaleate 57073-55-9 C17H28N4O7S
Ampicillin Impurity U Ampicillin Impurity U
Canagliflozin Hydroperoxide Impurity Canagliflozin Hydroperoxide Impurity
(E)-2-hydroxy-4-(phenyldiazenyl)benzoic acid (E)-2-hydroxy-4-(phenyldiazenyl)benzoic acid 40038-46-8 C13H10N2O3
Sitagliptin EP Impurity 6 Sitagliptin EP Impurity 6
Vonoprazan-005 Vonoprazan-005 2514735-09-0 C33H27F3N4
D-erythro-Hexonic acid, 6-S-2-benzothiazolyl-2,4-dideoxy-6-thio-, 1,1-dimethylethyl ester D-erythro-Hexonic acid, 6-S-2-benzothiazolyl-2,4-dideoxy-6-thio-, 1,1-dimethylethyl ester 1469771-46-7 C17H23NO4S2
(1R,2R,4S,5S,7s,9R)-9-butyl-7-(((S)-3-hydroxy-2-phenylpropanoyl)oxy)-9-methyl-3-oxa-9-azatricyclo[3.3.1.02,4]nonan-9-ium bromide (1R,2R,4S,5S,7s,9R)-9-butyl-7-(((S)-3-hydroxy-2-phenylpropanoyl)oxy)-9-methyl-3-oxa-9-azatricyclo[3.3.1.02,4]nonan-9-ium bromide
1-Demethyl Hydroxy Daunomycinone 1-Demethyl Hydroxy Daunomycinone 58199-98-7 C20H16O9
(S)-2-(butylsulfonamido)-3-(4-(4-(1-methylpiperidin-4-yl)butoxy)phenyl)propanoic acid (S)-2-(butylsulfonamido)-3-(4-(4-(1-methylpiperidin-4-yl)butoxy)phenyl)propanoic acid 1631053-75-2 C23H38N2O5S
FEXOFENADINE EP IMPURITY A - HCl FEXOFENADINE EP IMPURITY A - HCl 153439-43-1 C32H38ClNO4
2-[(4-Chloro-3-Methyl-2-Pyridinyl-methyl)thio]-1H-Benzimidazole 2-[(4-Chloro-3-Methyl-2-Pyridinyl-methyl)thio]-1H-Benzimidazole 103312-62-5 C14H12ClN3S
Pazufloxacin Pazufloxacin 127046-18-8 C18H19FN2O4
Vinpocetine Vinpocetine 80038-06-8 C22H26N2O2
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