Dabrafenib Related Compounds & Impurities

Dabrafenib is a selective ATP-competitive BRAF kinase inhibitor used in combination with the MEK inhibitor trametinib for BRAF V600-mutant melanoma, NSCLC and thyroid 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 Dabrafenib reference standards, pharmacopeial and non-pharmacopeial Dabrafenib 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 Dabrafenib-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

Dabrafenib
Dabrafenib Mesylate
Dabrafenib Impurity 10
Dabrafenib N-Oxide Impurity 2
Dabrafenib Impurity 11
Dabrafenib Di-N-Oxide Impurity
Dabrafenib Impurity 12
Dabrafenib Impurity 13
Dabrafenib Impurity 14
Dabrafenib Impurity 15
Dabrafenib Impurity 7
Dabrafenib Impurity 1
Dabrafenib Impurity 2
Dabrafenib Impurity 3
Dabrafenib Impurity 17
Dabrafenib Impurity 18
Dabrafenib Impurity 19
Dabrafenib Impurity 20
Dabrafenib Impurity 16
Dabrafenib Amine Impurity
Dabrafenib Impurity 23
Dabrafenib Impurity 24
Dabrafenib Impurity 25
Dabrafenib Impurity 26
Dabrafenib N-Oxide Impurity
Dabrafenib Methoxy Impurity
2,2-Dimethylthiopropionamide
Dabrafenib Impurity 28
Dabrafenib Impurity 4
Dabrafenib Impurity 5
Dabrafenib Impurity 6
Dabrafenib Diamine Sulfonamide Impurity
Dabrafenib Mesylate Form-I
Dabrafenib Impurity 8
Dabrafenib Impurity 9
Dabrafenib Impurity 22
Dabrafenib Impurity 21

Metabolites

Hydroxy Dabrafenib
Desmethyl-Dabrafenib
Carboxy Dabrafenib

Isotope Labelled Compounds

Dabrafenib-D9