Description

Dabrafenib Desmethyl Impurity is a key process-related impurity and a critical reference standard in the pharmaceutical development and quality control of the anticancer drug Dabrafenib. This high-purity compound is essential for ensuring the safety, efficacy, and regulatory compliance of the final drug product. It is primarily utilized by pharmaceutical manufacturers, analytical laboratories, and research institutions involved in method development, stability studies, and impurity profiling for targeted cancer therapies.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material for the identification and quantification of the desmethyl impurity in Dabrafenib active pharmaceutical ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: Critical for developing and validating sensitive HPLC, UPLC, or LC-MS methods to monitor impurity levels throughout the manufacturing process.
• Quality Control & Batch Release Testing: Used in routine QC testing to ensure that Dabrafenib batches meet stringent pharmacopeial (e.g., USP, EP) and internal purity specifications.
• Stability Studies & Degradation Pathway Analysis: Employed to study the degradation profile of Dabrafenib under various stress conditions (e.g., heat, light, humidity) as part of ICH stability guidelines.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., FDA, EMA) to establish impurity thresholds, justify specifications, and demonstrate control of the manufacturing process.
• Research & Development: Used in synthetic chemistry R&D to understand and optimize the synthesis pathway of Dabrafenib, aiming to minimize the formation of this specific impurity.

Basic Information

Product Name	Dabrafenib Desmethyl Impurity
CAS No.	1195765-47-9
Molecular Formula	C22H20F3N5O3S2
Molecular Weight	523.55 g/mol
Synonyms	N-{3-[5-(2-Amino-4-pyrimidinyl)-2-(1,1-dimethylethyl)-1,3-thiazol-4-yl]-2-fluorophenyl}-2,6-difluorobenzenesulfonamide; Desmethyl Dabrafenib; Dabrafenib Impurity D; Dabrafenib N-Desmethyl Impurity; GSK2118436 Desmethyl Impurity; Tafinlar Desmethyl Impurity; (GSK)2118436 Desmethyl; Dabrafenib Related Compound D
EINECS	Contact for details

Quality Control

Every batch of Dabrafenib Desmethyl Impurity (CAS 1195765-47-9) is manufactured under strict quality management systems and undergoes comprehensive analytical testing. Our products are characterized using advanced techniques including HPLC, LC-MS, NMR, and IR to confirm identity and ensure high purity, typically ≥95% (HPLC). A detailed Certificate of Analysis (COA) is provided with each shipment, documenting batch-specific results for identity, purity, and related substances. We support compliance with ICH Q3A/B, USP, and EP guidelines for impurities in new drug substances.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, ideally between 15-25°C (59-77°F). This compound is hygroscopic (moisture-sensitive); the container must be kept in a dry environment and sealed tightly after each use to prevent absorption of moisture. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any single unknown impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0% w/w

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