Description

Regorafenib Impurity 16 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for pharmaceutical quality control, enabling the accurate identification, quantification, and monitoring of this specific impurity during the development and manufacturing of the anticancer drug Regorafenib. It is an essential material for analytical chemists, quality assurance laboratories, and research institutions focused on ensuring drug safety, efficacy, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the qualitative and quantitative analysis of Regorafenib.
• Method Development and Validation: Crucial for developing and validating sensitive analytical methods, such as HPLC and LC-MS, for impurity profiling.
• Quality Control & Assurance (QC/QA): Used in in-process testing and final release testing of active pharmaceutical ingredients (APIs) and finished drug products to ensure impurity levels are within specified limits.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., for FDA, EMA) by providing definitive impurity characterization data required for drug master files (DMFs).
• Stability Studies: Employed to track the formation and growth of this impurity over time under various storage conditions.
• Research & Development: Used in synthetic chemistry research to study impurity formation pathways and to develop purification processes.

Basic Information

Product Name	Regorafenib Impurity 16
CAS No.	1343498-71-4
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Regorafenib Related Compound 16; Regorafenib EP Impurity 16; Regorafenib USP Impurity 16; 4-[4-({[4-Chloro-3-(trifluoromethyl)phenyl]carbamoyl}amino)-3-fluorophenoxy]-N-methylpyridine-2-carboxamide Impurity; BAY 73-4506 Impurity 16; Stivarga Impurity 16
EINECS	Contact for details

Quality Control

Every batch of Regorafenib Impurity 16 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques to ensure compliance with pharmacopeial standards (e.g., USP, EP) and customer-specific requirements. 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 in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept under dry, inert conditions to maintain stability and purity. For long-term storage, consider storing under an inert atmosphere such as argon or nitrogen.

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)	Single unspecified impurity ≤ 1.0% Total impurities ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 0.5%

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