Description

Sorafenib Impurity 6 is a designated pharmaceutical reference standard used for analytical and quality control purposes. This compound is critical for ensuring the purity, safety, and efficacy of the active pharmaceutical ingredient Sorafenib, a kinase inhibitor used in cancer therapy. It is an essential material for pharmaceutical R&D laboratories, quality assurance departments, and manufacturers engaged in the production and regulatory compliance of Sorafenib drug substances and products.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the identification and quantification of impurities in Sorafenib API.
• Method Development & Validation: Critical for developing and validating analytical methods (e.g., HPLC, UPLC) in compliance with ICH guidelines.
• Quality Control & Batch Release: Used in routine QC testing to monitor impurity profiles and ensure drug substance specifications are met.
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., CMC sections for FDA, EMA) by providing characterized impurity data.
• Stability Studies: Employed to track the formation of degradation products during forced degradation and long-term stability studies of Sorafenib formulations.
• Research & Development: Facilitates process chemistry optimization by identifying and controlling process-related impurities.

Basic Information

Product Name	Sorafenib Impurity 6
CAS No.	2204442-52-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Sorafenib Related Compound 6; Sorafenib Impurity; 4-(4-Aminophenoxy)-N-methylpicolinamide derivative (related to Sorafenib); BAY 43-9006 Impurity 6; Sorafenib Tosylate Impurity 6; Nexavar Impurity 6
EINECS	Contact for details

Quality Control

Every batch of Sorafenib Impurity 6 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity analysis, and impurity profiling using advanced chromatographic and spectroscopic techniques to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for purity, assay, and related substances.

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)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Water Content (KF)	≤ 5.0%

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