Enzalutamide Related Compounds & Impurities

Enzalutamide is a second-generation androgen receptor inhibitor that blocks androgen binding, nuclear translocation and DNA binding, used for metastatic and non-metastatic castration-resistant prostate cancer.

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 Enzalutamide reference standards, pharmacopeial and non-pharmacopeial Enzalutamide 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 Enzalutamide-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

Enzalutamide
N-Desmethyl Enzalutamide
Enzalutamide Impurity 2
Oxo-Enzalutamide
Desfluro Enzalutamide
Enzalutamide Impurity 6
4-Amino-2-fluoro-N-methylbenzamide
Apalutamide Impurity 16
Enzalutamide Impurity J
Enzalutamide Impurity B
Enzalutamide Impurity 11
Enzalutamide Carboxylic Acid
Enzalutamide Impurity 7
Enzalutamide Impurity P
Enzalutamide EP Impurity B
Enzalutamide Impurity 35
Enzalutamide Impurity D
Enzalutamide Impurity C
Enzalutamide Impurity 36
Enzalutamide Impurity 8
Enzalutamide Impurity 20
Enzalutamide Impurity 66
N-[4-cyano-3-(trifluoromethyl)phenyl]-N'-methylthiourea
Enzalutamide Impurity E
Enzalutamide Impurity 23
Enzalutamide Impurity 1
Apalutamide Impurity 14
Apalutamide Impurity 18
4-isothiocyanato-2-(trifluoromethyl)benzamide
Enzalutamide Impurity 26
Enzalutamide Impurity 43
Enzalutamide Impurity 41
Enzalutamide Nitroso Impurity 2
4-(3-(4-carbamoyl-3-(trifluoromethyl)phenyl)-5,5-dimethyl-2,4-dioxoimidazolidin-1-yl)-2-fluoro-N-methylbenzamide
N-Dimethyl Enzalutamide
Enzalutamide Impurity 14
Enzalutamide Impurity 10
Enzalutamide Impurity 22
Enzalutamide Impurity 59
Enzalutamide Impurity 60
4-(Ethylamino)-2-fluoro N-methyl benzamide
Enzalutamide Impurity 61
Enzalutamide Impurity 62
N-Nitroso Enzalutamide
N-Nitroso Enzalutamide Impurity 3
Enzalutamide Impurity 20
Enzalutamide Impurity 44
Enzalutamide Impurity 63
Enzalutamide Impurity 64
N-Nitroso Enzalutamide Impurity D
Enzalutamide Impurity 53
Enzalutamide Impurity 65
Enzalutamide Nitroso Impurity 1
Enzalutamide Impurity 72
Enzalutamide Impurity 73
Enzalutamide Impurity 74
N-Nitroso Enzalutamide Impurity 5
Enzalutamide Impurity 21
Enzalutamide Impurity 9
Desfluoro N-Methyl Methylbenzoate
C-Desmethyl enzalutamide acid impurity
Methyl 2-fluoro-4-nitrobenzoate
Enzalutamide Impurity O
2-Nitrobenzotrifluoride
1,2-Dinitro-3-(trifluoromethyl)benzene
1,3-Dinitro-2-(trifluoromethyl)benzene
2,4-Dinitrobenzotrifluoride
1-Trifluoromethyl-2,4,6-trinitrobenzene
Enzalutamide Impurity 71
Enzalutamide Impurity 84
Enzalutamide Impurity 85
Enzalutamide Nitroso Impurity 3
Enzalutamide Impurity 86
Enzalutamide Ethylester Impurity
Enzalutamide Hydrate
Enzalutamide Impurity 11
Enzalutamide mono Nitroso methyl ester
Enzalutamide Impurity 12
Enzalutamide Impurity 13
Enzalutamide impurity 4
Enzalutamide Impurity 15
Enzalutamide Impurity 16
Enzalutamide Impurity 17
Enzalutamide Impurity 18
N-Nitroso Enzalutamide Impurity 1
N-Nitroso Enzalutamide Impurity 2
Enzalutamide impurity 19
Enzalutamide Nitroso Impurity 4
Enzalutamide Nitroso Impurity 5
N-Nitroso Enzalutamide Impurity 4
Enzalutamide Impurity 24
Enzalutamide Impurity 25
Enzalutamide Impurity 27
Crystalline Form A polymorph of Enzalutamide
Enzalutamide Impurity 28
Enzalutamide Impurity 29

Metabolites

4-Fluoro-N-methyl-3-nitrobenzamide

Isotope Labelled Compounds

Enzalutamide-D3
N-Desmethyl Enzalutamide D6
Enzalutamide D6