Description

Sorafenib Impurity 14/Isopropyl (4-((2-(Methylcarbamoyl)Pyridin-4-Yl)Oxy)Phenyl)Carbamate is a high-purity chemical reference standard critical for pharmaceutical research and development. This compound serves as a specified impurity in the quality control and regulatory compliance of Sorafenib, a key oncology drug. It is essential for analytical chemists and quality assurance professionals in pharmaceutical manufacturing to ensure drug safety, efficacy, and adherence to stringent pharmacopeial standards. The availability of this well-characterized impurity supports method validation, stability studies, and the establishment of accurate impurity profiles.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the identification and quantification of impurities in Sorafenib drug substance and finished products.
• Analytical Method Development & Validation: Critical for developing, optimizing, and validating HPLC, UPLC, and LC-MS methods in quality control laboratories.
• Regulatory Compliance & Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing necessary impurity data for drug master files (DMFs) and investigational new drug (IND) applications.
• Stability Studies: Used to monitor impurity formation and degradation pathways in Sorafenib under various stress conditions (e.g., heat, light, humidity).
• Process Chemistry & Optimization: Aids in identifying and controlling impurity formation during the synthesis and scale-up of Sorafenib manufacturing processes.
• Pharmacopeial Testing: Employed to ensure batch-to-batch consistency and compliance with pharmacopeia monographs (e.g., USP, EP, ChP) for Sorafenib.

Basic Information

Item	Detail
Product Name	Sorafenib Impurity 14/Isopropyl (4-((2-(Methylcarbamoyl)Pyridin-4-Yl)Oxy)Phenyl)Carbamate
CAS No.	2206827-14-5
Molecular Formula	C18H21N3O5
Molecular Weight	359.38 g/mol
Synonyms	Isopropyl (4-((2-(Methylcarbamoyl)pyridin-4-yl)oxy)phenyl)carbamate; Sorafenib Related Compound 14; Sorafenib Impurity F; N-Methyl-4-(4-((isopropoxycarbonyl)amino)phenoxy)picolinamide; BAY 43-9006 Impurity 14; 4-(4-((Isopropoxycarbonyl)amino)phenoxy)-N-methylpicolinamide; Sorafenib N-Oxide Impurity (Related Structure)
EINECS	Contact for details

Quality Control

Every batch of Sorafenib Impurity 14 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques such as HPLC, LC-MS, NMR, and IR spectroscopy to ensure compliance with pharmaceutical reference standard requirements. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, including assay purity, related substances, residual solvents, and chromatographic data.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic nature, the container should be kept in a desiccated environment to prevent moisture absorption. For long-term storage, consider conditions under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 98.0%
Purity (HPLC, Area %)	≥ 99.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.10% Total impurities: ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 0.5%

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