Description

Lenvatinib Impurity 39 is a designated impurity of the active pharmaceutical ingredient Lenvatinib, a multi-kinase inhibitor used in oncology. This compound is critical for pharmaceutical research and development, serving as a reference standard for analytical method development, validation, and quality control processes. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies to ensure the purity, safety, and efficacy of Lenvatinib drug substances and products.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Lenvatinib Impurity 39 in drug substances and finished products.
• Analytical Method Development: Essential for developing and optimizing chromatographic methods (e.g., HPLC, UPLC) to separate and detect this specific impurity.
• Quality Control & Assurance: Employed in routine batch testing to monitor impurity profiles and ensure compliance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Stability Studies: Used to track the formation of this impurity under various stress conditions (e.g., heat, light, humidity) to establish product shelf-life.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Process Chemistry Research: Aids in understanding the formation pathway of this impurity during Lenvatinib synthesis, enabling process optimization for impurity minimization.

Basic Information

Product Name	Lenvatinib Impurity 39
CAS No.	2664101-53-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Lenvatinib Related Compound 39; Lenvatinib EP Impurity 39; Lenvatinib USP Impurity 39; 4-[3-Chloro-4-[[(3-fluorophenyl)carbamoyl]amino]phenoxy]-7-methoxyquinoline-6-carboxamide impurity; E7080 Impurity 39; Lenvima Impurity 39; Lenvatinib Degradant; Lenvatinib Process Impurity
EINECS	Contact for details

Quality Control

Our Lenvatinib Impurity 39 is manufactured under strict quality systems. Each batch undergoes comprehensive analytical testing, including HPLC purity determination and spectroscopic identification (NMR, MS), 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 and confirming compliance with in-house specifications.

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. The material should be kept in a dry environment to prevent moisture uptake. For long-term storage, consider storing under inert atmosphere.

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)	Individual unspecified impurity: ≤ 1.0% 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.