Description

Cabozantinib Impurity 14 is a designated impurity 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 the purity, safety, and efficacy of the final drug product. It is primarily required by professionals in pharmaceutical R&D, quality assurance (QA), and regulatory affairs for method development, validation, and batch release testing.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Cabozantinib-related impurities in API and finished drug products.
• Analytical Method Development & Validation: Essential for developing and validating stability-indicating HPLC/UPLC methods to monitor impurity profiles.
• Quality Control & Batch Release: A critical tool for in-house QC laboratories to establish specification limits and ensure compliance with ICH Q3A/B guidelines.
• Regulatory Submissions: Supports the preparation of regulatory dossiers (e.g., for FDA, EMA) by providing necessary impurity characterization data.
• Stability Studies: Employed to track the formation of this specific impurity under various stress conditions (heat, light, humidity) as per ICH stability protocols.
• Process Chemistry Research: Used by chemists to understand and optimize the synthetic pathway of Cabozantinib to minimize the formation of this impurity.

Basic Information

Product Name	Cabozantinib Impurity 14
CAS No.	1175127-32-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Cabozantinib Related Compound 14; Cabozantinib Impurity; Cabozantinib EP Impurity; Cabozantinib USP Impurity; Cabozantinib Process Impurity; XL184 Impurity 14; BMS-907351 Impurity
EINECS	Contact for details

Quality Control

Our Cabozantinib Impurity 14 is manufactured and handled under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC purity, identity confirmation (IR, MS), and residual solvent analysis, to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing all test results and traceability is provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at 2-8°C or as indicated on the label or COA. This product is hygroscopic (moisture-sensitive) and should be handled under anhydrous conditions to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (IR)	Spectrum conforms to reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 1.0% Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0%
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.