Description

Dabrafenib-D9 is a deuterated isotopologue of the BRAF kinase inhibitor Dabrafenib, specifically labeled with nine deuterium atoms. This stable isotope-labeled compound is essential for use as an internal standard in quantitative mass spectrometry, ensuring the highest accuracy and reliability in pharmacokinetic and bioanalytical studies. It is a critical tool for pharmaceutical researchers, clinical laboratories, and contract research organizations (CROs) engaged in drug metabolism and development programs targeting the MAPK/ERK signaling pathway.

Application

• Bioanalytical Internal Standard: Primary use as a certified reference material for Liquid Chromatography-Mass Spectrometry (LC-MS/MS) quantification of Dabrafenib in biological matrices like plasma, serum, and tissue homogenates.
• Pharmacokinetic (PK) and Toxicokinetic (TK) Studies: Enables precise measurement of drug absorption, distribution, metabolism, and excretion (ADME) profiles in preclinical and clinical research.
• Drug Metabolism Research: Facilitates the identification and quantification of Dabrafenib metabolites in vitro and in vivo, aiding in metabolic pathway elucidation.
• Clinical Trial Support: Critical for ensuring data integrity and regulatory compliance in bioanalysis for oncology clinical trials involving Dabrafenib-based therapies.
• Quality Control in Manufacturing: Can be utilized in analytical method development and validation for the quality control of Dabrafenib active pharmaceutical ingredient (API) and finished drug products.

Basic Information

Product Name	Dabrafenib-D9
CAS No.	1423119-98-5
Molecular Formula	C23H11D9F3N5O2S2
Molecular Weight	519.62 g/mol
Synonyms	N-{3-[5-(2-Amino-4-pyrimidinyl)-2-(1,1-dimethylethyl)-1,3-thiazol-4-yl]-2-fluorophenyl}-2,6-difluorobenzenesulfonamide-d9; Tafinlar-d9; GSK2118436B-d9; (3,5-Difluoro-2-{(1E)-1-[4-({[(2R)-2-hydroxy-2-phenylethyl]amino}methyl)phenyl]ethylidene}cyclohexyl)acetic acid-d9; BRAF inhibitor dabrafenib-d9; Deuterated Dabrafenib; Dabrafenib (deuterated); Dabrafenib Internal Standard
EINECS	Contact for details

Quality Control

Our Dabrafenib-D9 is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical characterization, including NMR (¹H, ¹³C, ²H) and High-Resolution Mass Spectrometry (HRMS) to confirm structural identity and isotopic enrichment. Purity is determined via validated HPLC and LC-MS methods. We provide a comprehensive Certificate of Analysis (COA) with each shipment, detailing batch-specific results for identity, chemical purity, isotopic purity (D-enrichment), and residual solvents, ensuring compliance with research and regulatory standards.

Storage

Preserve in a tightly closed container, protected from light. Store at -20°C or below in a dry, cool place. This product is hygroscopic (moisture-sensitive). For long-term storage, keep desiccated under an inert atmosphere. Allow the sealed vial to equilibrate to room temperature before opening to minimize moisture absorption.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (NMR)	Conforms to structure
Identification (HRMS)	Conforms to structure
Purity (HPLC)	≥98.0%
Isotopic Purity (D-enrichment)	≥98 atom % D
Chemical Purity (LC-MS)	≥95.0%
Water Content (KF)	≤1.0%
Residual Solvents (GC)	Meets ICH guidelines

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