Description

Sorafenib Impurity 3 is a specified impurity associated with the active pharmaceutical ingredient Sorafenib, a multi-kinase inhibitor. This compound is critical for pharmaceutical research and development, serving as a key reference standard for analytical method validation and quality control processes. It is primarily used by pharmaceutical manufacturers, contract research organizations (CROs), and quality control laboratories to ensure the purity, safety, and efficacy of Sorafenib drug substances and products.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Sorafenib active pharmaceutical ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating chromatographic methods (e.g., HPLC, UPLC) to monitor impurity profiles.
• Quality Control & Assurance (QC/QA): Employed in routine batch testing to ensure compliance with strict pharmacopeial (e.g., USP, EP) and ICH Q3A/B guidelines for impurity thresholds.
• Stability Studies: Used to track the formation and levels of this specific degradation product during forced degradation and long-term stability testing of Sorafenib formulations.
• Regulatory Submissions: Provides necessary data and characterization for regulatory filings (e.g., ANDA, NDA) to demonstrate comprehensive impurity control strategies.
• Process Chemistry Research: Aids in understanding and optimizing the synthetic pathway of Sorafenib to minimize the formation of this impurity.

Basic Information

Item	Details
Product Name	Sorafenib Impurity 3
CAS No.	284670-98-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	4-(4-{3-[4-Chloro-3-(trifluoromethyl)phenyl]ureido}phenoxy)-N-methylpyridine-2-carboxamide; Sorafenib Related Compound; Sorafenib Impurity B; BAY 43-9006 Impurity; 1-(4-Chloro-3-(trifluoromethyl)phenyl)-3-(4-(2-(methylcarbamoyl)pyridin-4-yloxy)phenyl)urea; Sorafenib N-Oxide Impurity (Note: This is a common synonym; confirm exact structure).
EINECS	Contact for details

Quality Control

Our Sorafenib Impurity 3 is manufactured under strict quality systems. Each batch undergoes comprehensive analytical characterization using advanced techniques such as HPLC, GC, MS, and NMR to confirm identity and purity. We provide a comprehensive Certificate of Analysis (COA) with each shipment, detailing batch-specific results. Our quality commitment aligns with ICH guidelines and supports compliance in regulated markets.

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 product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccants or inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0%
Water Content (KF)	≤ 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.