Description

Lenvatinib Impurity 107 is a designated impurity standard used in the pharmaceutical development and quality control of the active pharmaceutical ingredient (API) Lenvatinib. This high-purity reference material is critical for ensuring the safety, efficacy, and regulatory compliance of the final drug product by enabling accurate identification and quantification of this specific impurity. It is an essential tool for analytical laboratories, quality assurance teams, and research scientists in the pharmaceutical and biotechnology sectors focused on oncology therapeutics.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the identification and quantification of Lenvatinib Impurity 107 in Lenvatinib API and finished dosage forms.
• Method Development & Validation: Critical for developing, optimizing, and validating analytical methods, particularly High-Performance Liquid Chromatography (HPLC) and related techniques.
• Quality Control & Batch Release: Used in routine QC testing to monitor impurity profiles and ensure batches of Lenvatinib meet stringent pharmacopeial (e.g., USP, EP) and internal specification limits.
• Stability Studies: Employed to track the formation of this impurity over time under various stress conditions, supporting drug shelf-life determination.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., with FDA, EMA) to demonstrate thorough impurity characterization and control strategies.
• Research & Development: Supports synthetic route optimization and process chemistry studies aimed at minimizing the formation of this impurity during API manufacturing.

Basic Information

Product Name	Lenvatinib Impurity 107
CAS No.	417723-09-2
Molecular Formula	C21H19ClN4O4
Molecular Weight	426.86 g/mol
Synonyms	Lenvatinib Related Compound 107; Lenvatinib EP Impurity 107; Lenvatinib USP Impurity 107; 4-[3-Chloro-4-[[(3-fluorophenyl)carbamoyl]amino]phenoxy]-7-methoxyquinoline-6-carboxamide; E7080 Impurity 107; Lenvima Impurity 107
EINECS	Contact for details

Quality Control

Every batch of Lenvatinib Impurity 107 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using validated analytical methods (e.g., HPLC, NMR, MS) to ensure compliance with industry and pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C. Keep the container in a dry, cool, and well-ventilated area. For long-term storage, consider storing under inert atmosphere to ensure maximum stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Any individual impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0%

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