Description

Regorafenib Impurity H 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 (API) Regorafenib during its development and manufacturing. It is primarily required by pharmaceutical companies, contract research organizations (CROs), and quality control laboratories involved in the production of oncology therapeutics.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the qualitative and quantitative analysis of Regorafenib drug substance and drug products.
• Method Development and Validation: Essential for developing, optimizing, and validating analytical methods (e.g., HPLC, UPLC, LC-MS) to detect and quantify this specific impurity.
• Quality Control & Assurance (QC/QA): Used in routine batch testing to monitor impurity profiles and ensure compliance with strict regulatory specifications (ICH Q3A/B).
• Stability Studies: Employed to identify and track the formation of degradation products in Regorafenib formulations under various stress conditions.
• Regulatory Submissions: Provides necessary data for filing regulatory documents (e.g., CMC sections for FDA, EMA) to demonstrate control over the manufacturing process.
• Research and Development: Supports impurity identification, synthesis pathway research, and metabolic studies in preclinical and clinical development phases.

Basic Information

Product Name	Regorafenib Impurity H
CAS No.	2141961-84-2
Molecular Formula	C21H15ClF4N4O3
Molecular Weight	482.82 g/mol
Synonyms	Regorafenib Related Compound H; 4-[4-({[4-Chloro-3-(trifluoromethyl)phenyl]carbamoyl}amino)-3-fluorophenoxy]-N-methylpyridine-2-carboxamide; BAY 73-4506 Impurity H; Stivarga Impurity H; Regorafenib EP Impurity H; Regorafenib USP Impurity H; N-(4-Chloro-3-(trifluoromethyl)phenyl)-2-((4-fluorophenyl)amino)-N-methyl-4-oxo-1,4-dihydroquinoline-3-carboxamide Impurity
EINECS	Contact for details

Quality Control

Every batch of Regorafenib Impurity H is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC purity, identity confirmation (IR, MS), and residual solvent analysis, to ensure compliance with pharmacopeial standards (USP, EP) and ICH guidelines. 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 at controlled room temperature (15-25°C) or as indicated on the label. Due to its hygroscopic nature, the material should be handled in a dry environment and the container kept tightly sealed after each use to prevent moisture absorption.

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)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 1.0% w/w
Residual Solvents (GC)	Complies with ICH Q3C

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