Pharmaceutical Impurity Reference Standards

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Structure Chemical Name CAS MF
Anagrelide Impurity 2 HCl Anagrelide Impurity 2 HCl
(R)-4-(2-(benzyl(methyl)amino)-1-hydroxyethyl)benzene-1,2-diol (R)-4-(2-(benzyl(methyl)amino)-1-hydroxyethyl)benzene-1,2-diol 317351-40-9 C16H19NO3
N,N'-Bis(4-hydroxyphenyl)hydrazine N,N'-Bis(4-hydroxyphenyl)hydrazine 158905-63-6 C12H12N2O2
Droxidopa Impurity M Droxidopa Impurity M
Vigabatrin Impurity 2 Vigabatrin Impurity 2
Aripiprazole peroxide degradation Impurity (MW:464Da) Aripiprazole peroxide degradation Impurity (MW:464Da)
Zileuton Impurity (MW = 279.31 Da) Zileuton Impurity (MW = 279.31 Da)
3'-chloro-3'-deoxythymidine (zidovudine impurity) 3'-chloro-3'-deoxythymidine (zidovudine impurity)
Rivaroxaban Impurity 81 Rivaroxaban Impurity 81
Salbutamol Impurity 37 Salbutamol Impurity 37
Gadobutrol Impurity 21 Gadobutrol Impurity 21
Flucloxacillin sodium EP Impurity E Flucloxacillin sodium EP Impurity E
Pyrazole Pyrazole
NA NA
Labetalone hydrochloride Labetalone hydrochloride 96441-14-4 C19H22N2O3.ClH
6-amino-2-(1-(2-fluorobenzyl)-1H-pyrazolo[3,4-b]pyridin-3-yl)-
7,9-dimethyl-7,9-dihydro-8H-purin-8-one 6-amino-2-(1-(2-fluorobenzyl)-1H-pyrazolo[3,4-b]pyridin-3-yl)- 7,9-dimethyl-7,9-dihydro-8H-purin-8-one 1361569-23-4 C20H17FN8O
5-(1-amino-2-(methylsulfonyl)ethyl)-2-methoxyphenol 5-(1-amino-2-(methylsulfonyl)ethyl)-2-methoxyphenol 2169153-70-0 C10H15NO4S
Bendamustine Impurity 14 Bendamustine Impurity 14
Canagliflozin Impurity 28 Canagliflozin Impurity 28
Edoxaban Impurity 24 (1S,2S,4R) Edoxaban Impurity 24 (1S,2S,4R) 2024614-21-7 C21H30ClN5O5
Edoxaban Impurity 39 Edoxaban Impurity 39 2081883-55-6 C14H27N3O3
Ezetimibe Impurity 34 Ezetimibe Impurity 34 2280081-69-6 C20H21NO4
Linagliptin Impurity 33 Linagliptin Impurity 33 2443735-53-1 C38H42N10O4
Milrinone Impurity 15 Milrinone Impurity 15 156033-07-7 C12H9N3O2
Milrinone Impurity 6 Milrinone Impurity 6
Pantoprazole Impurity 2 Pantoprazole Impurity 2
rac-Valsartan EP Impurity B rac-Valsartan EP Impurity B 1894176-44-3 C31H35N5O3
Sitafloxacin Dechloro Impurity Sitafloxacin Dechloro Impurity
Ticagrelor Related Compound 85 Ticagrelor Related Compound 85 1628340-74-8 C28H34F2N6O5S
Valsartan Impurity 12 Valsartan Impurity 12 1189547-11-2 C11H21NO3
Vonoprazan Impurity 17 Vonoprazan Impurity 17
Avibactam Impurity B Avibactam Impurity B
Brexpiprazole Impurity L Brexpiprazole Impurity L
Cefaclor Impurity 4 Cefaclor Impurity 4
Linagliptin Impurity 38 Linagliptin Impurity 38 1979144-52-9 C20H17ClN6O2
Pidotimod Impurity N Pidotimod Impurity N
Pitavastatin (3S,5S)-Isomer Ethyl Ester Pitavastatin (3S,5S)-Isomer Ethyl Ester
Pramipexole Impurity 3 Pramipexole Impurity 3
Rupatadine Impurity A Rupatadine Impurity A
Sulpiride Impurity 2 Sulpiride Impurity 2
Tenofovir Impurity 55 Tenofovir Impurity 55
Voriconazole Impurity F Voriconazole Impurity F
Atorvastatin Impurity F Atorvastatin Impurity F 1371615-56-3 C66H68CaF2N4O10
Ambroxol  Impurity 8(Ambroxol  Impurity M) Ambroxol Impurity 8(Ambroxol Impurity M) 1445719-53-8 C13H16Br2N2O
Cefdinir impurity PQ mixture Cefdinir impurity PQ mixture
Loratadine Impurity 16 Loratadine Impurity 16 C22H23ClN2O2
Meptazinol BP Impurity D Meptazinol BP Impurity D 1883577-02-3 C30H44N2O
Prasugrel Impurity 12 Prasugrel Impurity 12
Pregabalin Impurity 16 Pregabalin Impurity 16
Nintedanib Impurity 26 Nintedanib Impurity 26
(3R,4R)-N,1,4-trimethyl-N-{7H-pyrrolo[2,3-d]pyrimidin-4-yl}piperidin-3-amine (3R,4R)-N,1,4-trimethyl-N-{7H-pyrrolo[2,3-d]pyrimidin-4-yl}piperidin-3-amine 2227197-38-6 C14H21N5
Varenicline Impurity 1 Varenicline Impurity 1
Amlodipine Impurity 27 Disodium Salt Amlodipine Impurity 27 Disodium Salt 120289-11-4 C19H20ClNO7
Erlotinib Impurity 47 HCl Erlotinib Impurity 47 HCl
Etoricoxib Impurity 33 Etoricoxib Impurity 33
2,2-dichloro-N-(2,3-dimethylphenyl)acetamide 2,2-dichloro-N-(2,3-dimethylphenyl)acetamide 18823-63-7 C10H11Cl2NO
2-(1-HydroxyCyclohexyl)-2-(4-MethoxyPhenyl)Acetonitrile 2-(1-HydroxyCyclohexyl)-2-(4-MethoxyPhenyl)Acetonitrile 93413-76-4 C15H19NO2
7-Hydroxy Alosetron 7-Hydroxy Alosetron 863485-44-3 C17H18N4O2
Dolutegravir 2-Desfluoro Impurity Dolutegravir 2-Desfluoro Impurity 1863916-88-4 C20H20FN3O5
Moxifloxacin Impurity 46 Moxifloxacin Impurity 46 1932499-97-2 C8H16N2
Posaconazole Impurity 43 Posaconazole Impurity 43 1428118-40-4 C13H20N2O2
Empagliflozin Impurity 32 Empagliflozin Impurity 32 1620758-25-9 C24H29ClO8
Sugammadex Impurity 16 Sugammadex Impurity 16 2412952-97-5 C69H108BrNaO46S7
1,1'-(1,4,8,11-tetraazacyclotetradecane-1,11-diyl)bis(2,2,2- trifluoroethan-1-one) dihydrochloride 1,1'-(1,4,8,11-tetraazacyclotetradecane-1,11-diyl)bis(2,2,2- trifluoroethan-1-one) dihydrochloride C14H24Cl2F6N4O2
9-fluoro-6,7-dihydro-5-methyl-1-oxo-8-(4-oxo-1,2,3,4-tetrahydro-1-pyridyl)-1H,5H-benzo[i,j]quinolizine-2-carboxylic acid 9-fluoro-6,7-dihydro-5-methyl-1-oxo-8-(4-oxo-1,2,3,4-tetrahydro-1-pyridyl)-1H,5H-benzo[i,j]quinolizine-2-carboxylic acid 130539-72-9 C19H17FN2O4
Clopidogrel Clopidogrel 444728-15-8 C15H15ClN2OS
(3R,5S)-5-((S)-8-fluoro-4-isopropyl-2-(N-methylmethyl sulfonamido)-5,6-dihydrobenzo[h]quinazolin-6-yl)-3,5- dihydroxypentanoate calcium(II) (3R,5S)-5-((S)-8-fluoro-4-isopropyl-2-(N-methylmethyl sulfonamido)-5,6-dihydrobenzo[h]quinazolin-6-yl)-3,5- dihydroxypentanoate calcium(II) 854898-50-3 C44H54CaF2N6O12S2
Arbidol Impurity I Arbidol Impurity I 153633-10-4 C22H24Br2N2O3S
Palonosetron Impurity 9 Palonosetron Impurity 9 2216755-75-6 C18H24N2O
Zopiclone Impurity 12 Zopiclone Impurity 12
Selexipag impurity Selexipag impurity
2-(3-formyl-4-isobutoxyphenyl)-N,N,4-trimethylthiazole- 5-carboxamide 2-(3-formyl-4-isobutoxyphenyl)-N,N,4-trimethylthiazole- 5-carboxamide 1380049-42-2 C18H22N2O3S
Benidipine Impurity V Benidipine Impurity V
Cefazolin USP Impurity L-△2 Cefazolin USP Impurity L-△2
Fluconazole Impurity M Fluconazole Impurity M C13H12F2N6O
Nicorandil Impurity 14 Nicorandil Impurity 14
Ticagrelor Impurity 64 Ticagrelor Impurity 64
Ticagrelor Impurity 71 Ticagrelor Impurity 71
Tolterodine EP Impurity G Tolterodine EP Impurity G 1554029-91-2 C22H32NO2+
Topiroxostat Impurity 23 Topiroxostat Impurity 23 2044706-78-5 C20H12N10
Saxagliptin Impurity 34 Saxagliptin Impurity 34 2173146-31-9 C17H25NO5
Afatinib Impurity 25 Afatinib Impurity 25
Bendamustine Impurity 34 Bendamustine Impurity 34
Canagliflozin Impurity 29 Canagliflozin Impurity 29
Cefazolin Impurity 6 Cefazolin Impurity 6 66636-33-7 C14H20N4O3S3Si
Ciprofloxacin Impurity 5 Ciprofloxacin Impurity 5 C17H18FN3O3
Erlotinib Impurity 53 Erlotinib Impurity 53 749181-30-4 C21H25N3O4
Etoposide Impurity 4 Etoposide Impurity 4 101648-60-6 C35H32Cl6O16
Olaparib Impurity 25 Olaparib Impurity 25 1423030-11-8 C16H9FO4
Olaparib Impurity 32 Olaparib Impurity 32
Oseltamivir Impurity 23 Oseltamivir Impurity 23 2241125-39-1 C9H16N2O3
Rosuvastatin Impurity 85 Rosuvastatin Impurity 85
Amoxicillin Impurity T Amoxicillin Impurity T C16H19N3O5S
Apremilast Impurity OH Apremilast Impurity OH
Atracurium Impurity T Atracurium Impurity T
Dextrorotation lansoprazole Impurity H Dextrorotation lansoprazole Impurity H
Dextrorotation lansoprazole Impurity M Dextrorotation lansoprazole Impurity M
lansoprazole Impurity 26 lansoprazole Impurity 26
Lincomycin sulfone Impurity 2 Lincomycin sulfone Impurity 2
Palbociclib Impurity 31 Palbociclib Impurity 31
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