Description

Cabozantinib Impurity 11 is a designated impurity reference standard used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) Cabozantinib. This compound is critical for pharmaceutical manufacturers and analytical laboratories to ensure product purity, safety, and regulatory compliance. It is primarily used in research and development, method validation, and stability studies for the production of Cabozantinib, a targeted cancer therapy.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of Cabozantinib Impurity 11 in drug substance and drug product batches.
• Analytical Method Development & Validation (HPLC/LC-MS): Essential for developing, optimizing, and validating chromatographic methods to monitor and control impurity levels.
• Stability Indicating Studies: Used to track the formation of this specific impurity under various stress conditions (e.g., heat, light, humidity) to establish product shelf-life.
• Quality Control & Release Testing: A critical component in the QC laboratory for routine batch analysis to ensure compliance with ICH guidelines and regulatory specifications.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., FDA, EMA) to demonstrate thorough impurity characterization and control strategies.
• Process Chemistry Research: Aids in understanding and optimizing the Cabozantinib synthesis pathway to minimize the formation of this impurity.

Basic Information

Product Name	Cabozantinib Impurity 11
CAS No.	861345-47-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Cabozantinib Related Compound 11; Cabozantinib Impurity; Cabozantinib EP Impurity J; Cabozantinib USP Impurity; Cabozantinib Process Impurity; N-[4-(6,7-Dimethoxyquinolin-4-yl)oxy]phenyl]-N'-(4-fluorophenyl)cyclopropane-1,1-dicarboxamide Impurity; XL184 Impurity 11
EINECS	Contact for details

Quality Control

Every batch of Cabozantinib Impurity 11 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity analysis, and impurity profiling using advanced techniques like HPLC and LC-MS to ensure they meet the exacting standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, analytical methods, and traceability.

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 in a desiccated environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (MS)	Mass spectrum conforms to structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 1.0% 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.