Description

Dabrafenib Hydroxy is a key pharmaceutical intermediate and reference standard of significant importance in modern oncology research and drug development. This compound is primarily valued for its role in the synthesis and quality control of targeted cancer therapies. It is essential for researchers and manufacturers in the pharmaceutical and biotechnology sectors who are developing or producing BRAF kinase inhibitors.

Application

• Pharmaceutical Intermediate: Critical building block in the synthesis of Dabrafenib, a targeted therapy for melanoma and non-small cell lung cancer.
• Reference Standard: Used in analytical laboratories for method development, validation, and quality control (QC) testing of active pharmaceutical ingredients (APIs).
• Metabolite Studies: Employed in pharmacokinetic and pharmacodynamic research to study the metabolism and efficacy of parent drug compounds.
• Process Development: Serves as a key material in scaling up and optimizing manufacturing processes for oncology drugs.
• Impurity Profiling: Utilized to identify, quantify, and control related substances and degradation products in final drug formulations.
• Regulatory Submissions: Provides essential data and materials for regulatory filings with agencies like the FDA and EMA.

Basic Information

Product Name	Dabrafenib Hydroxy
CAS No.	1195767-77-1
Molecular Formula	C23H20F3N5O3S2
Molecular Weight	535.56 g/mol
Synonyms	N-{3-[5-(2-Amino-4-pyrimidinyl)-2-(1,1-dimethylethyl)-1,3-thiazol-4-yl]-2-fluorophenyl}-2,6-difluorobenzenesulfonamide; Dabrafenib Hydroxy Impurity; Dabrafenib Metabolite Hydroxy; GSK2118436 Hydroxy; Tafinlar Hydroxy Impurity; (3-(5-(2-Aminopyrimidin-4-yl)-2-tert-butylthiazol-4-yl)-2-fluorophenyl)(2,6-difluorophenyl)sulfonamide
EINECS	Contact for details

Quality Control

Our Dabrafenib Hydroxy is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC, NMR, and MS, to ensure high purity and identity confirmation. We provide full traceability and Certificates of Analysis (COA) are available for all shipments, detailing purity, impurities, and other critical parameters to support your regulatory and research requirements.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Conforms
Identification (IR)	Conforms
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual impurity ≤ 0.5%
Total Impurities	≤ 2.0%
Residual Solvents (GC)	Complies with ICH guidelines
Water Content (KF)	≤ 1.0%

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.