Description

Lenvatinib Impurity O CAS NO 2143930-76-9 is a specified impurity of the active pharmaceutical ingredient Lenvatinib, a multi-kinase inhibitor used in targeted cancer therapy. This high-purity reference standard is critical for pharmaceutical research, development, and quality control, enabling accurate identification, quantification, and monitoring of this specific impurity during drug substance and product manufacturing. It is an essential material for analytical method development, validation, and stability studies, primarily serving pharmaceutical manufacturers, contract research organizations (CROs), and regulatory testing laboratories focused on oncology drug development.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the qualitative and quantitative analysis of Lenvatinib and related drug products.
• Analytical Method Development & Validation: Critical for developing and validating HPLC, UPLC, and LC-MS methods to detect and quantify Lenvatinib Impurity O in compliance with ICH guidelines.
• Quality Control & Assurance (QC/QA): Used in routine batch release testing and stability studies to ensure drug substance and product purity meets pharmacopeial (e.g., USP, EP) and regulatory specifications.
• Regulatory Submissions: Supports the preparation of regulatory dossiers (e.g., for FDA, EMA) by providing impurity profile data and characterization reports.
• Stability Studies: Employed to monitor the formation and levels of this impurity under various stress conditions (e.g., heat, humidity, light) as per ICH Q1A(R2).
• 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 O
CAS No.	2143930-76-9
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Lenvatinib Related Compound O; Lenvatinib EP Impurity O; Lenvatinib USP Impurity O; 4-[3-Chloro-4-[[(cyclopropylcarbonyl)amino]phenoxy]-7-methoxyquinoline-6-carboxamide impurity; E7080 Impurity O; Lenvima Impurity O
EINECS	Contact for details

Quality Control

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

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 compound is hygroscopic (moisture-sensitive); the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (MS)	Conforms
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Water Content (KF)	≤ 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.