Description

Cabozantinib Impurity 49 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 ensuring the purity, safety, and efficacy of the final drug product by serving as a reference marker in chromatographic analysis. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in the development, production, and quality assurance of Cabozantinib-based therapies.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Cabozantinib Impurity 49 in API and finished drug products.
• Method Development and Validation: Essential for developing and validating stability-indicating analytical methods, such as HPLC and UPLC, for Cabozantinib.
• Quality Control (QC) Testing: Employed in routine QC testing to monitor impurity levels and ensure batch-to-batch consistency complies with ICH guidelines.
• Stability Studies: Used to track the formation of this specific impurity under various stress conditions (e.g., heat, light, humidity) during drug stability studies.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., with FDA, EMA) to establish impurity profiles and justify specification limits.
• Research and Development: Supports process chemistry research to understand and minimize the formation of this impurity during API synthesis.

Basic Information

Product Name	Cabozantinib Impurity 49
CAS No.	190728-26-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Cabozantinib Related Compound 49; Cabozantinib EP Impurity C; Cabozantinib USP Impurity; Cabozantinib Process Impurity; XL184 Impurity 49; BMS-907351 Impurity; N-[4-(6,7-Dimethoxyquinolin-4-yloxy)phenyl]-N'-(4-fluorophenyl)cyclopropane-1,1-dicarboxamide Impurity
EINECS	Contact for details

Quality Control

Every batch of Cabozantinib Impurity 49 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using validated methods, including HPLC and spectroscopic techniques, to ensure compliance with pharmacopeial standards (USP/EP/ICH). A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment to support your quality and regulatory requirements.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. This material is typically hygroscopic (moisture-sensitive); therefore, the container should be kept in a dry environment.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Any individual impurity ≤ 1.0%
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.