Description

Regorafenib Impurity 13 is a designated impurity standard used in the pharmaceutical development and quality control of the anticancer drug Regorafenib. This high-purity reference material is critical for ensuring the safety, efficacy, and regulatory compliance of the final drug product. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions involved in method validation, stability studies, and impurity profiling.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of Regorafenib Impurity 13 in active pharmaceutical ingredient (API) and finished drug product batches.
• Analytical Method Development & Validation: Used as a critical component in developing and validating HPLC, UPLC, or LC-MS methods for impurity analysis.
• Quality Control & Assurance (QC/QA): Essential for routine quality control testing to monitor impurity levels and ensure batch-to-batch consistency according to ICH guidelines.
• Stability Studies: Employed to track the formation and growth of this specific impurity under various stress conditions (e.g., heat, light, humidity) during drug stability testing.
• Regulatory Compliance & Filing: Provides necessary data for regulatory submissions (e.g., to FDA, EMA) to establish impurity thresholds and control strategies.
• Research & Development: Used in synthetic chemistry research to understand degradation pathways and to support the development of robust manufacturing processes.

Basic Information

Product Name	Regorafenib Impurity 13
CAS No.	2909-32-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	4-[4-({[4-Chloro-3-(trifluoromethyl)phenyl]carbamoyl}amino)-3-fluorophenoxy]-N-methylpyridine-2-carboxamide Impurity 13; BAY 73-4506 Impurity 13; Stivarga Impurity 13; Regorafenib Related Compound 13; 4-(4-((4-Chloro-3-(trifluoromethyl)phenyl)carbamoyl)amino)-3-fluorophenoxy)-N-methylpicolinamide Impurity; UNII-9I0L8C2F2S (component); Regorafenib EP Impurity F (potential designation); Regorafenib Process Impurity
EINECS	Contact for details

Quality Control

Our Regorafenib Impurity 13 is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure it meets the high standards required for pharmaceutical reference materials. Each batch is characterized and released with a comprehensive Certificate of Analysis (COA) that includes data from HPLC purity, identity confirmation (e.g., by IR, MS), and residual solvent analysis. We support compliance with ICH Q3A/B guidelines and can provide materials suitable for use in regulatory filings.

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 should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%

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