Description

Lenvatinib Impurity 2 is a specified impurity of the active pharmaceutical ingredient Lenvatinib, a multi-kinase inhibitor used in targeted cancer therapy. This compound is critical for pharmaceutical research and development, serving as a key reference standard for analytical method development, quality control, and regulatory compliance. It is essential for manufacturers, analytical laboratories, and regulatory bodies involved in the production and validation of Lenvatinib to ensure drug safety, efficacy, and purity.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Lenvatinib Impurity 2 in drug substances and products.
• Analytical Method Development & Validation: Crucial for developing, optimizing, and validating chromatographic methods (e.g., HPLC, UPLC) to monitor impurities.
• Quality Control & Assurance (QC/QA): Used in routine batch testing to ensure Lenvatinib API meets stringent pharmacopeial (e.g., USP, EP) and ICH Q3A/B guidelines for impurity profiles.
• Stability Studies: Employed to track the formation of this specific degradation product under various stress conditions to establish drug shelf-life.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., FDA, EMA) to demonstrate thorough understanding and control of the impurity.
• Process Chemistry Research: Aids in understanding the formation pathway during Lenvatinib synthesis, helping to optimize manufacturing processes to minimize impurity generation.

Basic Information

Product Name	Lenvatinib Impurity 2
CAS No.	2380197-90-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Lenvatinib Related Compound 2; Lenvatinib EP Impurity 2; Lenvatinib USP Impurity 2; Lenvatinib Process Impurity; 4-[3-Chloro-4-[(cyclopropylcarbamoyl)amino]phenoxy]-7-methoxyquinoline-6-carboxamide Impurity; E7080 Impurity 2
EINECS	Contact for details

Quality Control

Our Lenvatinib Impurity 2 is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation (IR, MS), to ensure it meets the high standards required for use as a pharmaceutical reference standard. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with every shipment, supporting compliance with ICH and cGMP guidelines.

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 maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 1.0% Total impurities ≤ 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.