Description

Sorafenib Impurity 72 is a designated impurity reference standard used in the analytical profiling and quality control of the active pharmaceutical ingredient Sorafenib Tosylate. 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, quality control laboratories, and regulatory bodies involved in the development and production of Sorafenib-based anticancer therapies.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of related substances in Sorafenib Tosylate API batches.
• Method Development and Validation: Essential for developing, optimizing, and validating stability-indicating HPLC/UPLC methods in pharmaceutical R&D.
• Quality Control and Batch Release: Employed in routine QC testing to monitor impurity levels and ensure compliance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Stability Studies: Used to track the formation of this specific impurity during forced degradation and long-term stability studies of drug substances and products.
• Regulatory Submissions: Provides necessary impurity characterization data for regulatory filings (e.g., ANDA, NDA) with agencies like the US FDA and EMA.
• Pharmacopoeial Testing: Supports testing to meet monograph specifications for Sorafenib in various pharmacopoeias (e.g., USP, EP).

Basic Information

Product Name	Sorafenib Impurity 72
CAS No.	1261456-08-9
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Sorafenib Related Compound 72; Sorafenib Tosylate Impurity 72; 4-(4-{3-[4-Chloro-3-(trifluoromethyl)phenyl]ureido}phenoxy)-N-methylpyridine-2-carboxamide impurity; BAY 43-9006 Impurity 72; Nexavar Impurity 72; Sorafenib N-Oxide Impurity (Potential); Sorafenib Process-Related Impurity
EINECS	Contact for details

Quality Control

Our Sorafenib Impurity 72 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC purity determination and spectroscopic characterization (NMR, MS), to ensure identity, strength, and composition. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. Our quality standards align with ICH guidelines for impurity reference standards.

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.

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.