Description

Sorafenib Impurity 64 is a designated impurity associated with the active pharmaceutical ingredient Sorafenib. This compound is critical for pharmaceutical research and development, serving as a key reference standard for analytical method development and quality control. It is primarily used by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies to ensure the purity, safety, and efficacy of Sorafenib drug products. The availability of a well-characterized impurity standard is essential for meeting stringent regulatory requirements and maintaining high-quality production standards.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Sorafenib drug substance and finished products.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating chromatographic methods (e.g., HPLC, UPLC) to separate and detect related substances.
• Quality Control & Assurance (QC/QA): Employed in routine batch testing to monitor impurity profiles and ensure compliance with pharmacopeial specifications (e.g., ICH Q3A/B guidelines).
• 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 for regulatory filings (e.g., ANDA, NDA) to establish impurity thresholds and control strategies.
• Process Chemistry Research: Aids in understanding the formation pathways of this impurity during the synthesis of Sorafenib, enabling process optimization and impurity minimization.

Basic Information

Product Name	Sorafenib Impurity 64
CAS No.	1183968-98-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Sorafenib Related Compound 64; Sorafenib Impurity D (Check with supplier); N-[4-Chloro-3-(trifluoromethyl)phenyl]-N'-{4-[2-(carbamoylmethylcarbamoyl)pyridin-4-yloxy]phenyl}urea (Potential IUPAC); BAY 43-9006 Impurity 64; Sorafenib Tosylate Impurity 64; 4-(4-{3-[4-Chloro-3-(trifluoromethyl)phenyl]ureido}phenoxy)pyridine-2-carboxylic acid (2-amino-2-oxoethyl)amide; Sorafenib N-Oxide Impurity (Verify structure)
EINECS	Contact for details

Quality Control

Our Sorafenib Impurity 64 is manufactured under controlled conditions and undergoes rigorous analytical testing to ensure high purity and accurate identification. Each batch is characterized using advanced techniques including HPLC, MS, and NMR to confirm its structure and purity profile. We provide a comprehensive Certificate of Analysis (COA) with each shipment, detailing batch-specific results. Our quality system is designed to support compliance with ICH guidelines and other relevant regulatory standards for pharmaceutical impurities.

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. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (MS)	Mass spectrum conforms to structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any single unknown impurity ≤ 1.0%
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.