Description

Cabozantinib Impurity 1 CAS NO 748707-58-6 is a designated impurity reference standard used in the analytical profiling of the active pharmaceutical ingredient (API) Cabozantinib. This compound is critical for ensuring the quality, safety, and efficacy of the final drug product by enabling accurate identification and quantification of related substances. It is an essential material for pharmaceutical R&D laboratories, quality control (QC) units, and regulatory affairs teams involved in the development and manufacturing of Cabozantinib-based therapies.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Cabozantinib Impurity 1 in drug substance and drug product testing.
• Method Development and Validation: Critical for developing and validating stability-indicating analytical methods, such as HPLC and UPLC, in compliance with ICH guidelines.
• Quality Control & Batch Release: Used in routine QC testing to monitor impurity levels and ensure every batch of Cabozantinib API meets stringent pharmacopeial (e.g., USP, EP) and internal specifications.
• Stability Studies: Employed to track the formation of this specific impurity over time under various stress conditions (e.g., heat, light, humidity) as part of forced degradation and shelf-life studies.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., FDA, EMA) to establish impurity profiles, justify specification limits, and demonstrate control of the manufacturing process.
• Process Chemistry Research: Aids chemists in understanding and optimizing the synthetic pathway of Cabozantinib to minimize the formation of this impurity.

Basic Information

Product Name	Cabozantinib Impurity 1
CAS No.	748707-58-6
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Cabozantinib Related Compound 1; Cabozantinib Impurity; Cabozantinib EP Impurity 1; Cabozantinib USP Impurity 1; (S)-N-(4-((6,7-dimethoxyquinolin-4-yl)oxy)phenyl)-N'-(4-fluorophenyl)cyclopropane-1,1-dicarboxamide; UNII-9J8C4M8U7B; 9J8C4M8U7B
EINECS	Contact for details

Quality Control

Our Cabozantinib Impurity 1 is manufactured and handled under strict quality management systems. Each batch undergoes rigorous analytical testing, including chromatographic purity assays and structural confirmation, to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for identity, purity, and impurities. We support compliance with ICH Q3A, Q3B, and relevant pharmacopeial guidelines.

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 inert conditions or in a desiccator after opening to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches 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.