Description

Lenvatinib Impurity E is a designated 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 primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions involved in the synthesis, purification, and quality assurance 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 E in drug substances and finished products.
• Analytical Method Development & Validation: Essential for developing and validating stability-indicating HPLC, UPLC, or LC-MS methods to monitor impurity profiles.
• Quality Control & Batch Release: Employed in routine QC testing to ensure Lenvatinib batches meet stringent pharmacopeial (e.g., USP, EP) and ICH Q3A/B guidelines for impurities.
• Stability Studies: Used to track the formation and level of this specific impurity under various stress conditions (heat, light, humidity) as part of forced degradation and shelf-life studies.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., FDA, EMA) to establish impurity thresholds, specifications, and control strategies.
• Process Chemistry Research: Aids in understanding and optimizing the Lenvatinib synthesis pathway to minimize the formation of this impurity.

Basic Information

Product Name	Lenvatinib Impurity E
CAS No.	417717-20-5
Molecular Formula	C21H19ClN4O4
Molecular Weight	426.86 g/mol
Synonyms	4-[3-Chloro-4-[[(cyclopropylamino)carbonyl]amino]phenoxy]-7-methoxy-6-quinolinecarboxamide; Lenvatinib Related Compound E; Lenvatinib EP Impurity E; Lenvatinib USP Impurity E; E7040 Impurity E; 6-Quinolinecarboxamide, 4-[3-chloro-4-[[(cyclopropylamino)carbonyl]amino]phenoxy]-7-methoxy-; Lenvatinib N-Oxide Impurity (structural analog); Lenvatinib Process Impurity
EINECS	Contact for details

Quality Control

Our Lenvatinib Impurity E is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical characterization using techniques such as HPLC, LC-MS, NMR, and IR to confirm identity and purity. We provide a comprehensive Certificate of Analysis (COA) with each shipment, detailing batch-specific results. The material is suitable for use as a reference standard in compliance with ICH Q3A, Q3B, USP, and European Pharmacopoeia guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive); the container must be kept tightly sealed in a dry environment to prevent absorption of moisture.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0% w/w
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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