Description

Cabozantinib Impurity CAS NO 1355031-15-0 is a high-purity chemical reference standard used in the pharmaceutical development and quality control processes. This compound is critical for ensuring the safety and efficacy of the active pharmaceutical ingredient (API) Cabozantinib by accurately identifying and quantifying related substances. It is an essential tool for analytical chemists and quality assurance professionals working in pharmaceutical research, development, and manufacturing. The impurity standard supports compliance with stringent regulatory guidelines for drug substance characterization.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the identification and quantification of impurities in Cabozantinib API.
• Method Development & Validation: Critical for developing and validating analytical methods, particularly High-Performance Liquid Chromatography (HPLC) and Liquid Chromatography-Mass Spectrometry (LC-MS).
• Quality Control (QC) Testing: Used in routine QC laboratories to monitor impurity profiles and ensure batch-to-batch consistency of Cabozantinib drug substance and finished products.
• Stability Studies: Employed to track the formation of degradation products under various stress conditions, supporting shelf-life determination.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., with FDA, EMA) to demonstrate comprehensive impurity control strategies.
• Process Chemistry Research: Aids in understanding and optimizing the synthetic pathway of Cabozantinib to minimize the formation of this specific impurity.

Basic Information

Item	Detail
Product Name	Cabozantinib Impurity
CAS No.	1355031-15-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Cabozantinib Related Compound; Cabozantinib Impurity Standard; Cabozantinib Specified Impurity; Cabozantinib Process Impurity; Cabozantinib Degradant; Cabozantinib Reference Standard; Cabozantinib CRM
EINECS	Contact for details

Quality Control

Every batch of Cabozantinib Impurity is manufactured and handled under strict quality management systems. The product undergoes rigorous identity confirmation and purity analysis using advanced techniques such as HPLC, NMR, and Mass Spectrometry to ensure it meets the exacting standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each lot, detailing the analytical results and confirming compliance with specified criteria. Our quality commitment supports your adherence to ICH Q3A/B, USP, and EP guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F), in a dry environment. For long-term stability, storage at 2-8°C is recommended. Handle the material under appropriate conditions to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (MS)	Mass spectrum conforms to structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0%
Water Content (KF)	≤ 2.0%
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.