Description

Cabozantinib Impurity 47 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) 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 47 in API and finished drug products.
• Method Development and Validation: Critical for developing, optimizing, and validating stability-indicating analytical methods, such as HPLC and UPLC.
• Quality Control & Batch Release: Used in routine QA/QC testing to monitor impurity levels and ensure compliance with International Council for Harmonisation (ICH) Q3A(R2) and Q3B(R2) guidelines.
• Stability Studies: Employed to track the formation and growth of this specific impurity under various stress conditions (e.g., heat, light, humidity) during drug substance and product stability testing.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., FDA, EMA) to establish impurity thresholds and justify specifications.
• Process Chemistry Research: Aids in understanding the formation pathway of this impurity during Cabozantinib synthesis, enabling process optimization and impurity control.

Basic Information

Product Name	Cabozantinib Impurity 47
CAS No.	113136-79-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Cabozantinib Related Compound 47; Cabozantinib EP Impurity C; Cabozantinib USP Impurity; Cabozantinib Process Impurity; Cabozantinib Degradant; 1-N-{4-[(6,7-Dimethoxy-4-quinazolinyl)oxy]phenyl}-1-N'-(4-fluorophenyl)-1,1-cyclopropanedicarboxamide Impurity; XL184 Impurity 47; BMS-907351 Impurity
EINECS	Contact for details

Quality Control

Every batch of Cabozantinib Impurity 47 is manufactured under a quality management system and undergoes rigorous analytical characterization to ensure identity, purity, and consistency. Our products are supplied with a comprehensive Certificate of Analysis (COA) that includes data from orthogonal techniques such as HPLC, NMR, and MS. We support compliance with ICH, USP, and EP guidelines for impurity standards. COAs are available for review and regulatory submission support.

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. The material is light-sensitive (store away from light). For long-term storage, consider storing desiccated under inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (MS)	Mass spectrum consistent with structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 2.0% Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.