Apalutamide Related Compounds & Impurities

Apalutamide is a selective androgen receptor antagonist that blocks receptor translocation and DNA binding, used for non-metastatic and 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 Apalutamide reference standards, pharmacopeial and non-pharmacopeial Apalutamide 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 Apalutamide-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

Apalutamide
Apalutamide Des methyl impurity
Apalutamide Desfluoro Impurity
6,8-Dioxo Apalutamide
Apalutamide Impurity 2
Apalutamide Dithio Impurity
Apalutamide Acid Impurity
Apalutamide N-Oxide
Apalutamide Impurity 7
Apalutamide Impurity 3
5-(5-(3-fluoro-4-(methylcarbamoyl)phenyl)-8-oxo-6-thioxo-5,7-diazaspiro[3.4]octan-7-yl)-3-(trifluoromethyl)picolinic acid
Apalutamide Amine Impurity
Apalutamide Impurity 5
Apalutamide Impurity 6
Apalutamide Impurity 10
Apalutamide Impurity 13
Apalutamide Impurity 11
Apalutamide Impurity 19
Apalutamide Impurity 20
Apalutamide Thioamide
Apalutamide Oxamide
Apalutamide Marker Sample
N-Nitroso Apalutamide Amine Impurity
5-(Hydroxyamino)-3-(trifluoromethyl)picolinonitrile
Apalutamide Impurity 15
Apalutamide Impurity 4
Apalutamide Impurity 22
Apalutamide Impurity 23
Apalutamide Impurity 24
Apalutamide Form A
Apalutamide Form C
Apalutamide Form D
N-Nitroso Apalutamide Impurity 3
Apalutamide Nitroso Impurity 3
N-Nitroso Apalutamide
N-Nitroso Apalutamide Impurity 1
N-Nitroso Apalutamide Impurity 2
Apalutamide Nitroso Impurity 4
Apalutamide Impurity 27
Apalutamide Methyl Ester Impurity
Apalutamide N-Formyl Impurity
Apalutamide Impurity 26
Apalutamide Impurity 8
Apalutamide Impurity 1
Apalutamide Impurity 9

Metabolites

2-fluoro-4-(hydroxyamino)-N-methylbenzamide

Isotope Labelled Compounds

Apalutamide 13CD3
N-Desmethyl Apalutamide-D4
[13C2,15N]-N-Desmethyl Apalutamide
Apalutamide D4
Apalutamide D7