Apixaban Related Compounds & Impurities

Apixaban is a direct oral factor Xa inhibitor anticoagulant used for stroke prevention in atrial fibrillation and VTE treatment, with predictable pharmacokinetics avoiding routine coagulation monitoring.

Simson Pharma Limited along with its subsidiary offices Simson Pharma Global Ltd. (UK) and Simson Pharma Global LLC (USA) is a trusted manufacturer and supplier of high-quality pharmaceutical reference standards, offering a comprehensive portfolio of Apixaban reference standards, pharmacopeial and non-pharmacopeial Apixaban impurities, related compounds, related substances, metabolites, stable isotope-labelled compounds, deuterium labelled compounds and nitrosamine (N-NO) reference standards.

These materials support pharmaceutical research and development, product development, ANDA and DMF submissions, quality control (QC), analytical method development and validation, stability studies, impurity identification, and genotoxic impurity assessment.

Our Apixaban-related reference standards are thoroughly characterized using advanced analytical techniques and are supplied with comprehensive Certificates of Analysis (COA) and supporting analytical data from our USFDA certified, ISO 17025 and ISO 17034 accredited Lab, to meet global regulatory expectations. EP and USP traceable reference standards can also be provided upon request, subject to availability. Simson is also a provider of EP and USP traceable standards. To ensure consistent quality and reliability, our reference standards are periodically re-tested according to established quality management procedures.

Pharmaceutical Reference Standards / Impurity Standards

Apixaban
Apixaban Impurity A
O-Desmethyl Apixaban
Apixaban Amino Acid Impurity
Apixaban Related Compound E
Apixaban Ethyl Ester
Apixaban Chloro Impurity
4-Chloro pentanoyl chloride
5-chloro-hexanoyl chloride
Apixaban Impurity 36
N-(3-bromo-4-oxocyclohexyl)acetamide
O-Desmethyl Apixaban Sulfate
Apixaban Dehydro Impurity
Apixaban Related Compound D
Apixaban impurity of GGL-S157
4-Methyl-5-chlorovaleroyl Chloride
Apixaban Related Compound 3
Apixaban Impurity 4
Apixaban Impurity 2
Methyl,5-((4-(3-carbamoyl-1-(4-methoxyphenyl)-7-oxo-4,5-dihydro-1H-pyrazolo[3,4-c]pyridin-6(7H)-yl)phenyl)amino)pentanoate
Apixaban Impurity 13
Ethyl 2-Chloracetoacetate
Apixaban Impurity C
3-chloro-1-(4-nitrophenyl)-piperidin-2-one
5-Chloro-4-methylpentanoic acid
5-chlorohexanoic acid
Methyl 5-Chlorohexanoate
Ethyl 5-chlorohexanoate
1-(4-aminophenyl)-3-((4-(5-morpholino-6-oxo-3,6-dihydropyridin-1(2H)-yl) phenyl) amino)-5,6-dihydropyridin-2(1H)-one
Apixaban Impurity 32
Apixaban Dimer Impurity
Apixaban N-Oxide Dimer Impurity
Apixaban Impurity E
Apixaban Impurity 23
Apixaban Impurity 5
Apixaban Related Compound 1
Apixaban Related Compound 2
Apixaban Impurity 29
Apixaban Epoxy Impurity
Apixaban Stage I Impurity
Apixaban Ethyl Ester Impurity
Apixaban Carboxylic Acid Impurity
4-(1-(4-nitrophenyl)-1,4,5,6-tetrahydropyridin-3-yl)morpholine
Apixaban Impurity 47
Apixaban Impurity 17
Apixaban Impurity 15
Apixaban Impurity 19
Apixaban Isopropyl Ester Impurity
Apixaban Impurity 83
Apixaban Impurity 87
3-chloro-1-(4-(2-oxopiperidin-1-yl)phenyl)-5,6-dihydropyridin-2(1H)-one
Ethyl(2Z)-2-chloro-2-((4-methoxyphenyl)hydrazono)acetate
Apixaban Related Compound F
Apixaban Related Compound H
Apixaban Impurity 33
Apixaban Impurity 34
Apixaban Impurity 6
Potassium 3-carbamoyl-1-(4-methoxyphenyl)-4-(2-((4-(2-oxopiperidin-1-yl)phenyl)amino)ethyl)-1H-pyrazole-5-carboxylic acid
Apixaban Impurity 43
Apixaban Impurity 24
Apixaban Impurity 27
Apixaban Impurity 26
Apixaban Impurity 48
Apixaban Impurity 49
Apixaban Impurity 84
1-(4-(2-Oxopiperidin-1-yl)phenyl)-5,6-dihydropyridin-2(1H)-one
Apixaban Open Ring Amide
Apixaban Impurity 125
Apixaban Impurity 52
Apixaban Impurity 53
Apixaban Impurity 58
Apixaban Impurity 18
Desmethyl-O-Benzyl Apixaban
Apixaban Impurity D
2-Hydroxyethyl,1-(4-methoxyphenyl)-7-oxo-6-(4-(2-oxopiperidin-1-yl)phenyl)-4,5,6,7-tetrahydro-1H-pyrazolo[3,4-c]pyridine-3-carboxylate
1-(4-Methoxyphenyl)-6-(4-nitrophenyl)-7-oxo-4,5,6,7-tetrahydro-1H-pyrazolo[3,4-c]pyridine-3-carboxamide
Apixaban Methyl Impurity
Apixaban Impurity 14
Apixaban Impurity 16
Ethyl,2-chloro-2-(2-(4-chlorophenyl)hydrazono)acetate
Apixaban Ethoxy Impurity
Apixaban Nitroso Impurity 1
Apixaban Impurity 56
Apixaban Impurity 57
Apixaban Impurity 59
5-Chloropentanoic acid
5-Chloropentanoic anhydride
2,2-Dimethyl Heptane
3-ethyl-2,2-dimethylpentane
2,2,3-Trimethyl Hexane
2,2--Dimethyl tetradecane
2,2-Dimethylundecane
2,2,3,4-Tetramethyl Pentane
2,2-Dimethyl Octane
2,2,3-Trimethyl Decane
1-(4-nitrophenyl)-5,6-dihydropyridin-2(1H)-one
3-chloro-1-(2-nitrophenyl)5,6-dihydropyridin-2(1H)-one
3-chloro-1-(3-nitrophenyl)-5,6-dihydropyridin-2(1H)-one
(E)-Ethyl 2-chloro-2-(2-(4-methoxyphenyl)hydrazono)acetate
Apixaban Impurity 45
Apixaban Form N-1
Ethyl-2-chloro-2-(2-(4-hydroxyphenyl)hydrazineylidene)acetate
Apixaban Impurity 68
Apixaban Related Compound G
Apixaban Impurity 37
Apixaban Impurity 22
1-(4-Aminophenyl)-3,3-dichloro-2-piperdinone
Apixaban Impurity 80
Apixaban Impurity 81
N-Nitroso Apixaban Amino Acid Impurity
Apixaban Impurity 39
Apixaban Impurity 38
Iodophenyl Ethyl Ester Apixaban Impurity
Apixaban N-nitroso amino phenyl Impurity
Apixaban Impurity 95
Apixaban Impurity 92
Dehydro Desmethoxy Apixaban
3-acetyl-6-(4-aminophenyl)-1-( 4- methoxyphenyl)-1,4,5,6-tetrahydro-7Hpyrazolo[3,4-c] pyridine-7-one
Apixaban Impurity 99
1-(3-methoxyphenyl)-7-oxo-6-(4-(2-oxopiperidin-1-yl)phenyl)-4,5,6,7-tetrahydro-1H-pyrazolo[3,4-c]pyridine-3-carboxamide
Apixaban Nitroso Impurity 2
Apixaban Impurity 107
Apixaban Impurity 108
Apixaban Nitroso Impurity 4
Apixaban Impurity 71
Apixaban Impurity 73
Apixaban Impurity 111
Apixaban Impurity 100
Apixaban Nitroso Impurity 6
Apixaban Impurity 30
Apixaban Impurity 112
Apixaban Impurity 115
Apixaban Nitroso Impurity 8
Apixaban Impurity 46
Apixaban Impurity 82
Apixaban Impurity 121
Apixaban Impurity 123
Apixaban Impurity 122
Apixaban Impurity 124
(E)-ethyl2-chloro-2-(2-(3-methoxyphenyl)hydrazono)acetate
Apixaban Impurity 126
Apixaban Impurity 127
Apixaban Impurity 128
Apixaban Impurity 130
Apixaban Impurity 129
5-Bromo-4-methylpentanoic acid
5-Bromo-4-methylpentanoyl chloride
Apixaban Nitroso Impurity 9
Apixaban Carboxylic Acid O-Desmethyl Impurity
Apixaban Impurity 137
Apixaban Impurity 116
Apixaban Impurity 138
Apixaban Impurity 139
Apixaban Impurity 8
Apixaban Impurity 74
Apixaban Impurity 145
Apixaban Impurity 118
Apixaban Impurity 146
Apixaban Impurity 147
Apixaban Impurity 42
Apixaban Impurity 131
Apixaban Impurity 20
Apixaban Impurity 25
Apixaban impurity 3
Apixaban impurity 21
Apixaban impurity 28
Apixaban impurity 31
Apixaban Ester Impurity 1
Apixaban Ester Impurity 2
Apixaban Impurity 1
Apixaban impurity 35
Apixaban Impurity 40
Apixaban Impurity 41
Apixaban Impurity 7
N-Nitroso Apixaban Impurity 1
Apixaban Impurity 44
Apixaban Impurity 50
Apixaban Impurity 51

Metabolites

Hydroxyl Apixaban

Isotope Labelled Compounds

Apixaban-13C,D3
Apixaban-D3