Description

Lenvatinib Impurity F CAS NO 417717-21-6 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 ensuring the safety, efficacy, and regulatory compliance of the final drug product by enabling accurate identification and quantification during manufacturing. It is an essential material for pharmaceutical R&D laboratories, quality assurance/quality control (QA/QC) departments, and regulatory affairs teams focused on oncology therapeutics.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the identification and quantification of Lenvatinib Impurity F in drug substance and drug product batches.
• Method Development and Validation: Critical for developing, optimizing, and validating analytical methods such as HPLC, UPLC, and LC-MS for impurity profiling.
• Stability Studies: Used to monitor the formation and levels of this specific degradation product under various stress conditions (e.g., heat, light, humidity) to establish product shelf-life.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., FDA, EMA) to demonstrate comprehensive impurity control and characterization as per ICH Q3A(R2) and Q3B(R2) guidelines.
• Quality Control Testing: Serves as a system suitability standard and for routine batch release testing in pharmaceutical manufacturing to ensure impurity specifications are met.
• Research and Development: Supports synthetic route optimization and process chemistry studies by helping to identify and control the formation of this impurity.

Basic Information

Product Name	Lenvatinib Impurity F
CAS No.	417717-21-6
Molecular Formula	C21H19ClN4O4
Molecular Weight	426.85 g/mol
Synonyms	4-[3-Chloro-4-[[(cyclopropylamino)carbonyl]amino]phenoxy]-7-methoxy-6-quinolinecarboxamide; Lenvatinib Related Compound F; E7080 Impurity F; Lenvima Impurity F; Lenvatinib EP Impurity F; Lenvatinib USP Impurity F; (4-{[3-Chloro-4-({[(cyclopropyl)carbamoyl]amino})phenoxy]-7-methoxyquinoline-6-carboxamide)
EINECS	Contact for details

Quality Control

Every batch of Lenvatinib Impurity F is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing to ensure compliance with industry standards, including identity confirmation, purity assessment, and impurity profiling via advanced chromatographic and spectroscopic techniques. Certificates of Analysis (COA) are available upon request, providing full traceability and batch-specific data.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F). The material is hygroscopic (moisture-sensitive); keep the container tightly sealed in a dry environment to prevent absorption of moisture.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0% w/w
Residue on Ignition	≤ 0.2%
Heavy Metals	≤ 20 ppm

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