Description

Regorafenib Impurity CAS NO 1333390-56-9 is a high-purity chemical reference standard used in the pharmaceutical development and quality control processes of the anticancer drug Regorafenib. This impurity is critical for ensuring drug safety and efficacy by enabling accurate identification, quantification, and control of related substances during manufacturing. It is an essential material for analytical laboratories, regulatory affairs, and R&D departments within the global pharmaceutical and biotechnology sectors.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the identification and quantification of impurities in Regorafenib active pharmaceutical ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Critical for developing, optimizing, and validating HPLC, UPLC, and LC-MS methods in quality control laboratories.
• Regulatory Compliance & Filings: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing characterized impurity data for drug master files (DMFs) and investigational new drug (IND) applications.
• Stability Studies: Used as a marker to monitor impurity profiles and degradation pathways in stability testing of Regorafenib under various ICH conditions.
• Process Chemistry R&D: Aids chemists in understanding and optimizing synthetic pathways to minimize the formation of this specific impurity during API manufacturing.
• Quality Assurance/Quality Control (QA/QC): Serves as a system suitability standard and for routine batch release testing to ensure product specifications are met.

Basic Information

Product Name	Regorafenib Impurity
CAS No.	1333390-56-9
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Regorafenib Related Compound; Regorafenib Process Impurity; Regorafenib Degradant; BAY 73-4506 Impurity; 4-[4-({[4-Chloro-3-(trifluoromethyl)phenyl]carbamoyl}amino)-3-fluorophenoxy]-N-methylpyridine-2-carboxamide Impurity; Stivarga Impurity
EINECS	Contact for details

Quality Control

Our Regorafenib Impurity is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing, including advanced chromatographic techniques, to ensure identity, purity, and consistency. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. Our quality commitment aligns with cGMP principles and supports compliance with ICH Q3A(R2) and Q3B(R2) guidelines for impurities in new drug substances and products.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider desiccants or inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (MS)	Conforms
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity ≤ 0.5% Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0% w/w

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