Description

Lenvatinib Impurity D is a specified, high-purity chemical reference standard used in the analytical profiling and quality control of the active pharmaceutical ingredient Lenvatinib. This impurity is critical for pharmaceutical manufacturers and research laboratories to ensure drug safety, efficacy, and regulatory compliance by monitoring and controlling its presence. It is essential for method development, validation, and stability studies within the pharmaceutical and contract research organization (CRO) sectors.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the identification and quantification of Lenvatinib Impurity D in drug substance and finished product analysis.
• Analytical Method Development & Validation: Critical for developing and validating stability-indicating HPLC/UPLC methods to separate and measure process-related impurities.
• Quality Control & Batch Release: Used in routine QC testing of Lenvatinib API to ensure batches meet stringent pharmacopeial (e.g., USP, EP) and ICH guidelines for impurity limits.
• Stability Studies: Employed to monitor the formation of this specific impurity under various stress conditions (heat, light, humidity) to establish product shelf-life.
• Regulatory Submissions: Provides essential data for Drug Master Files (DMFs), Investigational New Drug (IND), and New Drug Application (NDA) filings to health authorities like the FDA and EMA.
• Research & Development: Supports synthetic route optimization and impurity fate and tolerance studies during API process development.

Basic Information

Product Name	Lenvatinib Impurity D
CAS No.	417717-04-5
Molecular Formula	C21H19ClN4O4
Molecular Weight	426.86 g/mol
Synonyms	4-[3-Chloro-4-[[(cyclopropylcarbonyl)amino]phenoxy]-7-methoxyquinoline-6-carboxamide; Lenvatinib Related Compound D; E7080 Impurity D; Lenvima Impurity D; (4-{[3-Chloro-4-(cyclopropylaminocarbonyl)aminophenoxy]-7-methoxyquinolin-6-yl}carbamoyl)benzoic Acid; UNII-7G8B8Y8K8Q
EINECS	Contact for details

Quality Control

Our Lenvatinib Impurity D is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical characterization using advanced techniques including HPLC, LC-MS, and NMR to confirm identity and purity, ensuring compliance with ICH Q3A(R2) and Q3B(R2) guidelines. A detailed Certificate of Analysis (COA) providing batch-specific data for identity, assay, purity, and related substances is supplied with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, 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%
Residue on Ignition	≤ 0.2%

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