Description

Sorafenib Impurity B11 is a designated impurity reference standard used in the analytical profiling and quality control of the active pharmaceutical ingredient Sorafenib. This compound is critical for ensuring the purity, safety, and efficacy of the final drug product by serving as a benchmark in chromatographic analysis. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in the development and quality assurance of Sorafenib-based oncology treatments.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Sorafenib API batches.
• Method Development and Validation: Essential for developing, optimizing, and validating analytical methods, particularly HPLC and UPLC.
• Quality Control & Assurance (QC/QA): A critical component in routine quality control testing to monitor impurity levels and ensure compliance with ICH guidelines.
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing impurity characterization data.
• Stability Studies: Employed to track the formation of degradation products in Sorafenib under various stability conditions.
• Research and Development: Used in pharmaceutical R&D to understand the degradation pathways and impurity profile of Sorafenib.

Basic Information

Product Name	Sorafenib Impurity B11
CAS No.	86416-59-3
Molecular Formula	C21H16ClF3N4O3
Molecular Weight	464.83 g/mol
Synonyms	4-(4-{3-[4-Chloro-3-(trifluoromethyl)phenyl]ureido}phenoxy)-N-methylpyridine-2-carboxamide; Sorafenib N-Oxide Impurity; BAY 43-9006 Impurity B11; Sorafenib Related Compound B11; 4-[4-[[[4-Chloro-3-(trifluoromethyl)phenyl]amino]carbonyl]amino]phenoxy]-N-methyl-2-pyridinecarboxamide 1-oxide
EINECS	Contact for details

Quality Control

Every batch of Sorafenib Impurity B11 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity analysis, and impurity profiling using advanced techniques like HPLC, LC-MS, and NMR to ensure they meet the stringent requirements for pharmaceutical reference standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

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 must be kept in a desiccated environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (IR)	Spectrum conforms to reference
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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