Description

Sorafenib Related Compound 12 is a high-purity chemical reference standard, identified by CAS NO 284461-74-1. This compound is critical for pharmaceutical research and development, particularly in analytical method development and quality control processes for the active pharmaceutical ingredient Sorafenib. It is primarily utilized by pharmaceutical manufacturers, contract research organizations (CROs), and analytical laboratories to ensure product purity, safety, and regulatory compliance.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of specific impurities in Sorafenib drug substance and drug product batches.
• Analytical Method Development & Validation: Serves as a critical standard for developing and validating HPLC, UPLC, and LC-MS methods to meet ICH Q2(R1) and other regulatory guidelines.
• Quality Control (QC) Testing: Employed in routine QC laboratories to monitor and control the quality of Sorafenib during manufacturing, ensuring it meets stringent pharmacopeial specifications (e.g., USP, EP).
• Stability Studies: Acts as a marker in forced degradation and long-term stability studies to understand the degradation pathways of Sorafenib.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., ANDA, NDA) to demonstrate comprehensive impurity control strategies to agencies like the FDA and EMA.
• Research & Development: Used in preclinical and clinical research to study the metabolism and pharmacokinetics of Sorafenib and its related substances.

Basic Information

Item	Detail
Product Name	Sorafenib Related Compound 12
CAS No.	284461-74-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Sorafenib Impurity 12; Sorafenib Related Substance 12; 4-(4-Aminophenoxy)-N-methylpicolinamide; BAY 43-9006 Related Compound 12; Nexavar Impurity 12; Sorafenib N-Oxide Impurity (Potential); Sorafenib Degradant
EINECS	Contact for details

Quality Control

Our Sorafenib Related Compound 12 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation via spectroscopic methods, to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. Our quality commitment aligns with cGMP principles to support your regulatory needs.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (typically 15-25°C). This product is hygroscopic (moisture-sensitive) and must be kept in a dry environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
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.