Niraparib Related Compounds & Impurities

Niraparib is a PARP inhibitor used for maintenance treatment of recurrent epithelial ovarian cancer regardless of BRCA status.

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 Niraparib reference standards, pharmacopeial and non-pharmacopeial Niraparib 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 Niraparib-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

Niraparib
Niraparib tosylate monohydrate
Niraparib Tosylate
ent-Niraparib
N-Nitroso Niraparib
Niraparib Impurity 5
tert-butyl(R)-3-(4-(7-carbamoyl-2H-indazol-2-yl)phenyl)piperidine-1-carboxylate
Niraparib Impurity 1
Niraparib Impurity 53
Niraparib Impurity 23
Niraparib Impurity 24
Niraparib Impurity 30
Niraparib Impurity 31
Niraparib Impurity 32
Niraparib Impurity 33
Niraparib Impurity 22
Niraparib Impurity 25
Niraparib Impurity 26
Niraparib Impurity 27
Niraparib Impurity 28
Niraparib Impurity 29
Tert-butyl(S)-3-(4-((2,3-bis(3-cyano-2-nitrophenyl)allyl)amino)phenyl)piperidine-1-carboxylate
Niraparib Impurity 37
(R)-2-nitro-3-(((4-(piperidin-3-yl)phenyl)amino)methyl)benzonitrile
Niraparib Impurity 39
Niraparib Impurity 40
Niraparib Impurity 41
Niraparib Impurity 42
Niraparib Impurity 43
Niraparib Impurity 45
Tert-butyl(S)-3-(4-((2,3-bis(3-cyano-2-nitrophenyl)allylidene)amino)phenyl)piperidine-1-carboxylate
(R)-tert-butyl 3-(4-((3-cyano-2-nitrobenzylidene)amino)phenyl)piperidine-1-carboxylate
Niraparib Impurity 49
Niraparib Impurity 50
Niraparib Impurity 51
Niraparib Impurity 52
3-Methyl-2-nitrobenzoic acid
Niraparib Impurity 62
Niraparib Impurity 63
Niraparib Impurity 64
Niraparib Impurity E
Niraparib Nitroso Impurity 2
Niraparib Nitroso Impurity 3
Niraparib Nitroso Impurity 4
Niraparib Nitroso Impurity 5
Niraparib Nitroso Impurity 6
Niraparib Nitroso Impurity 7
Niraparib Carboxylic Acid Nitroso Impurity
Niraparib Impurity 7
Niraparib Acid Impurity
Niraparib Impurity 8
Niraparib Impurity 9
Niraparib Impurity 11
Niraparib Impurity 62(E isomer)

Metabolites

Niraparib Carboxylic Acid

Isotope Labelled Compounds

Niraparib-13C6 Hydrochloride
Rac-Niraparib D4 Tosylate
N-Nitroso Niraparib D4