Description

Sorafenib Impurity 43 is a high-purity chemical reference standard used in pharmaceutical development and quality control. This compound is critical for the accurate identification, quantification, and monitoring of process-related impurities in Sorafenib drug substance and finished products. It is an essential tool for analytical chemists and quality assurance professionals in the pharmaceutical and biotechnology industries, ensuring product safety and regulatory compliance.

Application

• Pharmaceutical Impurity Profiling: Serves as a certified reference standard for the identification and quantification of a specific impurity in Sorafenib active pharmaceutical ingredient (API).
• Analytical Method Development and Validation: Used as a critical component in developing and validating stability-indicating HPLC, UPLC, or LC-MS methods for Sorafenib.
• Quality Control (QC) Testing: Employed in routine batch release testing of Sorafenib API and finished drug products to ensure impurity levels are within ICH/USP/EP specified limits.
• Stability Studies: Acts as a marker compound in forced degradation and long-term stability studies to track impurity formation over time and under various stress conditions.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., ANDA, NDA, CTA) to demonstrate thorough impurity characterization and control strategies.
• Research and Development: Used in process chemistry research to understand impurity formation pathways and optimize synthesis routes for Sorafenib.

Basic Information

Item	Details
Product Name	Sorafenib Impurity 43
CAS No.	757251-59-5
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Sorafenib Related Compound 43; Sorafenib Impurity C; 4-(4-{3-[4-Chloro-3-(trifluoromethyl)phenyl]ureido}phenoxy)-N-methylpicolinamide Impurity; BAY 43-9006 Impurity 43; Nexavar Impurity 43; Sorafenib Tosylate Impurity 43
EINECS	Contact for details

Quality Control

Every batch of Sorafenib Impurity 43 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques such as HPLC, LC-MS, NMR, and IR to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, chromatograms, and storage recommendations.

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 dry, inert conditions to maintain stability and purity. For long-term storage, consider storing under an inert atmosphere such as argon or nitrogen.

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)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0% w/w

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