Description

Sorafenib Impurity 13 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 pharmaceutical manufacturers and analytical laboratories to ensure product purity, safety, and regulatory compliance. It is primarily utilized in research and development, method validation, and stability studies for the anticancer drug Sorafenib.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Sorafenib drug substance and drug product batches.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating chromatographic methods, such as HPLC and UPLC, to separate and detect related substances.
• Quality Control & Assurance (QC/QA): Serves as a system suitability standard and for establishing impurity acceptance criteria in accordance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Stability Studies: Employed to monitor the formation of degradation products under various stress conditions (e.g., heat, light, humidity) to determine drug shelf-life.
• Regulatory Compliance & Filing: Supports the preparation of regulatory documentation (e.g., CMC sections for FDA, EMA, PMDA) by providing characterized impurity data.
• Process Chemistry Research: Aids in understanding and controlling the formation of this specific impurity during the synthesis and purification of Sorafenib.

Basic Information

Product Name	Sorafenib Impurity 13
CAS No.	583840-04-4
Molecular Formula	C21H16ClF3N4O3
Molecular Weight	464.82 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 13; Sorafenib Related Compound 13; 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 13 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 compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, analytical methods, and traceability.

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 under inert conditions or in a desiccator to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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