Description

Cabozantinib Impurity 4 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 an essential material for pharmaceutical R&D laboratories, quality assurance/quality control (QA/QC) departments, 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 4 in API and drug product batches.
• Method Development and Validation: Critical for developing, optimizing, and validating stability-indicating HPLC/UPLC methods in accordance with ICH guidelines.
• Quality Control and Batch Release: Used in routine QC testing to monitor impurity levels and ensure compliance with regulatory specifications (e.g., ICH Q3A(R2), Q3B(R2)).
• Stability Studies: Employed as an analytical standard in forced degradation and long-term stability studies to track impurity formation over time.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Process Chemistry Research: Aids in understanding the synthetic pathway of Cabozantinib and optimizing manufacturing processes to minimize this specific impurity.

Basic Information

Product Name	Cabozantinib Impurity 4
CAS No.	95932-39-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Cabozantinib Related Compound 4; Cabozantinib EP Impurity D; Cabozantinib USP Impurity D; Cabozantinib Process Impurity; 4-Fluoro-2-((4-((6,7-dimethoxyquinolin-4-yl)oxy)phenyl)amino)benzonitrile Impurity; XL184 Impurity 4; BMS-907351 Impurity 4; Cometriq Impurity
EINECS	Contact for details

Quality Control

Our Cabozantinib Impurity 4 is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical characterization using techniques such as HPLC, GC, NMR, and MS to confirm identity and purity. We provide Certificates of Analysis (COA) with detailed chromatographic data, including retention time matching and spectral confirmation against a primary reference standard. Our quality commitment aligns with the standards expected for pharmaceutical impurity reference materials, supporting compliance in GMP environments.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label. This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccation.

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 ≤ 2.0% 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.