Nilotinib Related Compounds & Impurities

Nilotinib is a second-generation BCR-ABL tyrosine kinase inhibitor with increased potency against imatinib-resistant CML mutations.

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 Nilotinib reference standards, pharmacopeial and non-pharmacopeial Nilotinib 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 Nilotinib-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

Nilotinib
Nilotinib monohydrate Hydrochloride
Nilotinib Impurity 27
Nilotinib EP Impurity A
Nilotinib N-Oxide
Nilotinib Regio Isomer Impurity
Nilotinib Imidazolyl N-Oxide
Nilotinib Impurity 14
Nilotinib Impurity 11
Nilotinib Amino Impurity
Nilotinib EP Impurity D
Nilotinib Pyrimidine N1-Oxide
Imidazole N-Oxide
Nilotinib EP Impurity G
Nilotinib Bromo Impurity
Nilotinib Impurity 2
Nilotinib Impurity 4
Nilotinib EP Impurity C
Nilotinib EP Impurity E
Nilotinib EP Impurity F
Nilotinib EP Impurity B
3-Amino-4-methylbenzoic Acid
Nilotinib EP Impurity E
Nilotinib Impurity 19
Nilotinib Impurity 1
3-(2-Methyl-1H-imidazol-1-yl)-5-(trifluoromethyl)aniline
4-methyl-N-[3-(2-methyl-1H-imidazol-1-yl)-5-(trifluoromethyl)phenyl]-3-[[4-(pyridine-3-yl)pyrimidin-2-yl]amino]benzamide
Nilotinib Impurity 31
Nilotinib Impurity 8
Nilotinib EP Impurity H
Nilotinib Impurity 24
Nilotinib Impurity 25
Nilotinib Impurity 26
Nilotinib Impurity A
Nilotinib Impurity E
Ethyl 3-Nitrobenzoate
3-Nitrobenzoic Acid
2-Methyl-6-nitrobenzoic Acid
Ethyl-2-methyl-6-nitrobenzoate
Diphenylphosphorazidate
5-(2-(2-carboxyphenyl)-2-oxoethyl)-2-fluorobenzoic acid
Nilotinib Impurity 21
Ethyl-4-methyl-3-nitrobenzoate
Nilotinib Impurity 18
Nilotinib Imidazolyl N-oxide
Ethyl 4-methyl-3-[(4-pyridin-3-ylpyrimidin-2-yl)amino]benzoate
tert-butyl N-[3-(4-methylimidazol-1-yl)-5-(trifluoromethyl)phenyl]carbamate
3-(5-ethyl-1H-imidazol-1-yl)-5-(trifluoromethyl)aniline
Fingolimod 4-Hydroxy Impurity
Nilotinib Impurity 29
2-(4-methyl-1H-imidazol-1-yl)-4-(trifluoromethyl)aniline
Nilotinib Nitroso Impurity 1
(E)-N-methyl-N-(3-oxo-3-(pyridin-3-yl)prop-1-en-1-yl)nitrous amide
N-Nitroso Nilotinib EP Impurity D
N-Nitroso Nilotinib Impurity 3
N-(3-(4-methyl-1H-imidazol-1-yl)-5-(trifluoromethyl)phenyl)-3-(nitroso(4-(pyridin-3-yl)pyrimidin-2-yl)amino)benzamide
Nilotinib Impurity 34
Nilotinib Impurity 35
Nilotinib 3-Pyridinyl Impurity
Nilotinib Hydrochloride Dihydrate
4-methyl-1-nitroso-1H-imidazole
Nilotinib Impurity 5
Nilotinib Impurity 40
N-Nitroso Nilotinib N-Oxide
Nilotinib Impurity 43
Nilotinib Impurity 44
Nilotinib Di N- oxide
Nilotinib Hydrochloride Monohydrate Form B
Nilotinib N-Oxide (Pyrimidine N3-Oxide)
Nilotinib Impurity 51
Nilotinib Impurity 52
Nilotinib Impurity 53
Nilotinib Impurity 54
Nilotinib Impurity 55
Nilotinib Impurity 60
Nilotinib Impurity 61
Nilotinib Impurity 59
Nilotinib Impurity 62
Nilotinib Impurity 58
Nilotinib Impurity 7
Nilotinib EP Impurity A Hydrocloride
Nilotinib EP Impurity D Sodium
Nilotinib Impurity 9

Isotope Labelled Compounds

Nilotinib-D6
Nilotinib D3
Nilotinib EP Impurity A-D3
Nilotinib-13C,D3