Description

Sorafenib Related Compound 22 is a high-purity chemical reference standard, identified by CAS No. 284462-89-1. This compound is critical for ensuring the quality, safety, and efficacy of the active pharmaceutical ingredient Sorafenib through rigorous analytical testing. It is primarily used by pharmaceutical manufacturers, contract research organizations (CROs), and quality control laboratories involved in the development and production of oncology therapeutics.

Application

• Pharmaceutical Impurity Profiling and Identification: Serves as a certified reference material for the identification and quantification of specific impurities or degradation products in Sorafenib drug substance and finished dosage forms.
• Analytical Method Development and Validation: Used as a critical standard to develop, optimize, and validate chromatographic methods (e.g., HPLC, UPLC) for stability-indicating assays.
• Quality Control and Batch Release Testing: Essential for routine quality control testing to ensure Sorafenib batches meet stringent pharmacopeial (e.g., USP, EP) or internal specification limits for related substances.
• Stability Studies: Employed in forced degradation and long-term stability studies to monitor the formation of this specific related compound under various stress conditions.
• Regulatory Submissions: Provides necessary data and reference standards for regulatory filings (e.g., FDA, EMA) to support drug approval and compliance.
• Research and Development: Utilized in pharmaceutical R&D to understand the degradation pathways and chemical behavior of Sorafenib during formulation development.

Basic Information

Product Name	Sorafenib Related Compound 22
CAS No.	284462-89-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	4-(4-Aminophenoxy)-N-methylpicolinamide; Sorafenib Impurity 22; Sorafenib Related Substance 22; BAY 43-9006 Related Compound 22; Nexavar Related Compound 22; Sorafenib N-Oxide (Potential isomer/structure); Sorafenib Process Impurity
EINECS	Contact for details

Quality Control

Every batch of Sorafenib Related Compound 22 is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including advanced chromatographic and spectroscopic techniques, to ensure identity, purity, and consistency. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results against defined specifications. We support compliance with cGMP, ICH Q7, and relevant pharmacopeial guidelines for pharmaceutical 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 conditions to prevent degradation. For long-term storage, consider desiccation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.2%

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