Description

Dabrafenib Impurity 1 is a high-purity reference standard specifically identified and characterized for pharmaceutical analysis. This compound is critical for ensuring the quality, safety, and regulatory compliance of the active pharmaceutical ingredient (API) Dabrafenib, a targeted therapy used in oncology. It serves as an essential tool for analytical method development, validation, and routine quality control testing in pharmaceutical research, development, and manufacturing.

Application

• Pharmaceutical Reference Standard: Primary application as a certified impurity standard for the qualification and quantification of related substances in Dabrafenib API and finished drug products.
• Analytical Method Development & Validation: Used to establish and validate chromatographic methods, such as HPLC and UPLC, for impurity profiling.
• Quality Control & Assurance (QC/QA): Essential for routine batch release testing to monitor impurity levels and ensure they remain within specified limits per ICH guidelines.
• Regulatory Compliance & Filings: Supports the preparation of regulatory documentation (e.g., CMC sections for FDA, EMA) by providing characterized impurity data.
• Stability Studies: Employed to identify and track potential degradation products formed during the stability testing of Dabrafenib formulations.
• Research & Development: Facilitates process chemistry research by helping to understand and control impurity formation during API synthesis.

Basic Information

Product Name	Dabrafenib Impurity 1
CAS No.	1907654-22-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Dabrafenib Related Compound 1; Dabrafenib Impurity; (2S)-N-[3-[5-(2-Aminopyrimidin-4-yl)-2-tert-butyl-1,3-thiazol-4-yl]-2-fluorophenyl]-2,6-difluorobenzenesulfonamide; Tafinlar Impurity 1; GSK2118436 Impurity 1; BRAF Inhibitor Dabrafenib Impurity
EINECS	Contact for details

Quality Control

Our Dabrafenib Impurity 1 is manufactured under strict quality systems to ensure it meets the exacting standards required for pharmaceutical reference materials. Each batch is subjected to comprehensive analytical characterization using techniques including HPLC, MS, and NMR to confirm identity and purity. A detailed Certificate of Analysis (COA) is provided with each shipment, containing batch-specific data. Our quality commitment aligns with the principles of current Good Manufacturing Practice (cGMP) and relevant ICH guidelines (Q3A, Q6A) for impurities in new drug substances.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F). The material should be kept in a dry environment to prevent moisture uptake. For long-term storage, consider storing under inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (MS)	Consistent with molecular structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 2.0% Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C

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