Description

Sorafenib Impurity Hc121-201904 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and efficacy of the active pharmaceutical ingredient Sorafenib, a multi-kinase inhibitor used in cancer therapy. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and quality control testing.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of related substances in Sorafenib drug substance and finished products.
• Analytical Method Development: Essential for developing and validating chromatographic methods (HPLC, UPLC) to monitor impurities during the drug manufacturing process.
• Quality Control & Assurance (QC/QA): Serves as a critical benchmark in routine quality control testing to ensure batch-to-batch consistency and compliance with ICH guidelines.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., ANDA, NDA) by providing necessary impurity profiles and stability data for health authorities like the FDA and EMA.
• Stability Studies: Employed in forced degradation and long-term stability studies of Sorafenib to understand its degradation pathways.
• Research & Development (R&D): Used in pharmaceutical R&D for studying the metabolism, pharmacokinetics, and impurity formation mechanisms of Sorafenib.

Basic Information

Product Name	Sorafenib Impurity Hc121-201904
CAS No.	1804875-27-1
Molecular Formula	C21H16ClF3N4O3
Molecular Weight	464.83 g/mol
Synonyms	Sorafenib Related Compound Hc121-201904; Sorafenib Impurity H; 4-(4-{3-[4-Chloro-3-(trifluoromethyl)phenyl]ureido}phenoxy)-N-methylpyridine-2-carboxamide Impurity; BAY 43-9006 Impurity Hc121; Sorafenib N-Oxide Impurity (Potential); Nexavar Impurity Hc121; Sorafenib Tosylate Impurity H
EINECS	Contact for details

Quality Control

Our Sorafenib Impurity Hc121-201904 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity, NMR and MS for structural confirmation, and residual solvent analysis to ensure compliance with ICH Q3A/B guidelines. A comprehensive Certificate of Analysis (COA) detailing all test results is provided with every shipment to support your regulatory and quality needs.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, ideally between 15°C and 25°C (59°F and 77°F). The material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (IR)	Spectrum conforms to reference
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Any individual impurity ≤ 1.0%
Total Impurities	≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5%

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