Description

Sorafenib Impurity Int-1-N is a high-purity chemical reference standard used in pharmaceutical research and development. This compound is critical for the analytical characterization and quality control of Sorafenib, an important kinase inhibitor medication. It is primarily utilized by pharmaceutical manufacturers, contract research organizations (CROs), and analytical laboratories to ensure drug purity, safety, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of related substances in Sorafenib active pharmaceutical ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating HPLC, UPLC, and LC-MS methods for impurity profiling.
• Quality Control & Assurance (QC/QA): Used in routine batch release testing to monitor impurity levels against International Council for Harmonisation (ICH) guidelines.
• Stability Studies: Employed to track the formation of this specific degradation product under various stress conditions (e.g., heat, humidity, light).
• Regulatory Submissions: Provides necessary data for Drug Master Files (DMFs), Investigational New Drug (IND) applications, and New Drug Applications (NDAs).
• Process Chemistry Research: Aids in understanding and controlling the formation of this impurity during the synthesis and scale-up of Sorafenib.

Basic Information

Item	Detail
Product Name	Sorafenib Impurity Int-1-N
CAS No.	1863331-80-9
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Sorafenib Related Compound Int-1-N; Sorafenib Intermediate Impurity 1-N; 4-(4-Aminophenoxy)-N-methylpicolinamide; BAY 43-9006 Impurity Int-1-N; Sorafenib N-Oxide Degradant; Nexavar Impurity Int-1-N; Sorafenib Process Impurity
EINECS	Contact for details

Quality Control

Every batch of Sorafenib Impurity Int-1-N 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, and NMR to ensure they meet the exacting standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

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, inert conditions to ensure long-term stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (MS)	Mass spectrum conforms to structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 5.0%

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