Description

Sorafenib Impurity 24/n-Methyl-4-[4-[[2-[(Methylamino)Carbonyl]-4-Pyridinyl]Amino]Phenoxy]-2-Pyridinecarboxamide is a high-purity reference standard critical for pharmaceutical research and development. This compound serves as a specified impurity in the quality control of Sorafenib, an important multi-kinase inhibitor active pharmaceutical ingredient (API). It is essential for analytical method development, validation, and regulatory compliance in pharmaceutical manufacturing. Quality-focused laboratories and API producers require this impurity to ensure the safety, efficacy, and purity of their final drug products.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Sorafenib Impurity 24.
• Analytical Method Development: Critical for developing and validating HPLC, UPLC, and LC-MS methods for impurity profiling of Sorafenib API.
• Quality Control & Assurance (QC/QA): Used in routine batch release testing to monitor impurity levels against ICH Q3A(R2) and Q3B(R2) guidelines.
• Regulatory Compliance & Filing: Supports the preparation of regulatory submission documents (e.g., for FDA, EMA) by providing impurity characterization data.
• Stability Studies: Employed to track the formation of this specific degradation product under various stress conditions.
• Process Chemistry Research: Aids in understanding and optimizing the Sorafenib synthesis pathway to minimize impurity formation.

Basic Information

Product Name	Sorafenib Impurity 24/n-Methyl-4-[4-[[2-[(Methylamino)Carbonyl]-4-Pyridinyl]Amino]Phenoxy]-2-Pyridinecarboxamide
CAS No.	2004659-83-8
Molecular Formula	C21H20N6O3
Molecular Weight	404.42 g/mol
Synonyms	Sorafenib Impurity 24; Sorafenib Related Compound 24; N-Methyl-4-[4-[[2-[(Methylamino)carbonyl]-4-pyridinyl]amino]phenoxy]-2-pyridinecarboxamide; 2-Pyridinecarboxamide, N-methyl-4-[4-[[2-[(methylamino)carbonyl]-4-pyridinyl]amino]phenoxy]-; BAY 43-9006 Impurity 24; Sorafenib N-Methyl Impurity; 4-(4-((2-(Methylcarbamoyl)pyridin-4-yl)amino)phenoxy)-N-methylpicolinamide
EINECS	Contact for details

Quality Control

Every batch of Sorafenib Impurity 24 is manufactured and analyzed under strict quality systems. Our products undergo rigorous quality testing to ensure compliance with industry standards for pharmaceutical reference materials. Comprehensive characterization is performed using advanced techniques including HPLC, LC-MS, NMR, and IR spectroscopy. Certificates of Analysis (COA) are provided with each shipment, detailing purity, identity, and impurity profile, supporting your regulatory and research needs.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C. The product is moisture-sensitive (hygroscopic); keep the container tightly sealed in a dry environment. For long-term storage, consider storing under inert atmosphere to ensure stability.

Specification

Item	Specification
Appearance	White to off-white solid
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%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
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.