Description

Sorafenib Impurity 16/Ethyl (4-((2-(Methylcarbamoyl)Pyridin-4-Yl)Oxy)Phenyl)Carbamate is a high-purity reference standard critical for the analytical profiling and quality control of the active pharmaceutical ingredient Sorafenib. This compound is essential for pharmaceutical manufacturers and analytical laboratories to identify, quantify, and control this specific impurity, ensuring the safety and efficacy of the final drug product. It is primarily used in research and development, method validation, and regulatory compliance activities within the pharmaceutical industry.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Sorafenib Impurity 16 in drug substance and drug product analysis.
• Method Development and Validation: Critical for developing and validating stability-indicating analytical methods, such as HPLC and UPLC, for Sorafenib.
• Quality Control (QC) Testing: Serves as a system suitability and calibration standard in routine QC testing to monitor impurity levels against ICH guidelines.
• Stability Studies: Employed in forced degradation and long-term stability studies to track the formation of this impurity under various stress conditions.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., FDA, EMA) to demonstrate thorough impurity characterization and control strategies.
• Research and Development: Used in synthetic chemistry research to study the formation pathways and chemical behavior of Sorafenib-related impurities.

Basic Information

Product Name	Sorafenib Impurity 16/Ethyl (4-((2-(Methylcarbamoyl)Pyridin-4-Yl)Oxy)Phenyl)Carbamate
CAS No.	2206827-12-3
Molecular Formula	C17H19N3O5
Molecular Weight	345.35 g/mol
Synonyms	Ethyl (4-((2-(methylcarbamoyl)pyridin-4-yl)oxy)phenyl)carbamate; Sorafenib Related Compound 16; Sorafenib EP Impurity J; Sorafenib Impurity J; BAY 43-9006 Impurity 16; 4-(4-(Ethoxycarbonylamino)phenoxy)-N-methylpicolinamide; N-Methyl-4-[4-[(ethoxycarbonyl)amino]phenoxy]pyridine-2-carboxamide
EINECS	Contact for details

Quality Control

Our Sorafenib Impurity 16 is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC purity determination, residual solvent analysis (GC), and structural confirmation (NMR, MS). We provide a detailed Certificate of Analysis (COA) with each shipment, which includes batch-specific data and confirms compliance with in-house specifications aligned with ICH Q3A/B guidelines. Our quality commitment ensures the material's suitability for its intended use as a high-grade reference standard.

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 product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider storing under an inert atmosphere.

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 single unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C
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.