Description

Cabozantinib Impurity 23 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 ensuring the purity, safety, and efficacy of the final drug product by serving as a benchmark in chromatographic analysis. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and routine batch testing.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of Cabozantinib Impurity 23 in Cabozantinib API and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing and validating stability-indicating HPLC/UPLC methods to monitor impurity profiles.
• Quality Control & Batch Release: Employed in routine QC testing to ensure drug substance and product meet stringent pharmacopeial (e.g., USP, EP) and ICH Q3A/B guidelines for impurities.
• Stability Studies: Used to track the formation and level of this specific impurity under various stress conditions (thermal, photolytic, hydrolytic) as part of forced degradation studies.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., ANDA, NDA) to demonstrate comprehensive impurity control strategies.
• Research & Development: Supports process chemistry research to understand impurity formation pathways and optimize synthesis routes for cleaner API production.

Basic Information

Item	Details
Product Name	Cabozantinib Impurity 23
CAS No.	406-00-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Cabozantinib Related Compound 23; Cabozantinib Impurity C; Cabozantinib EP Impurity C; Cabozantinib USP Impurity; 4-[(6,7-Dimethoxyquinolin-4-yl)oxy]-N-methyl-N-[4-(trifluoromethoxy)phenyl]cyclohexane-1-carboxamide Impurity; Cabozantinib Process Impurity; Cabozantinib Degradant
EINECS	Contact for details

Quality Control

Our Cabozantinib Impurity 23 is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including identification by spectroscopic methods (IR, NMR, MS) and purity determination by validated chromatographic techniques (HPLC). We provide a comprehensive Certificate of Analysis (COA) with each shipment, detailing batch-specific results, and our quality systems support compliance with cGMP and ICH guidelines for reference standards.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as specified on the certificate of analysis. The material should be kept in a dry environment to prevent moisture uptake.

Specification

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