Description

Lenvatinib Impurity 28 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the active pharmaceutical ingredient Lenvatinib. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling studies. The availability of a well-characterized impurity standard is essential for maintaining stringent quality control in drug production.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Lenvatinib API and finished drug products.
• Analytical Method Development: Essential for developing and validating HPLC, UPLC, or LC-MS methods for impurity detection and separation.
• Quality Control & Assurance (QC/QA): Serves as a system suitability standard in routine quality control testing to monitor batch-to-batch consistency.
• Regulatory Compliance & Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing necessary impurity data for drug master files (DMFs) and investigational new drug (IND) applications.
• Stability Studies: Employed to track the formation and level of this specific impurity during forced degradation and long-term stability testing of drug substances and products.
• Research & Development: Used in pharmaceutical R&D to study the degradation pathways, synthesis impurities, and metabolic profiles of Lenvatinib.

Basic Information

Product Name	Lenvatinib Impurity 28
CAS No.	417722-79-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Lenvatinib Related Compound 28; Lenvatinib EP Impurity G; Lenvatinib USP Impurity; 4-[3-Chloro-4-[(cyclopropylcarbamoyl)amino]phenoxy]-7-methoxyquinoline-6-carboxamide; E7080 Impurity 28; Lenvima Impurity 28; Lenvatinib Degradation Product; Lenvatinib Process Impurity
EINECS	Contact for details

Quality Control

Our Lenvatinib Impurity 28 is manufactured under strict quality systems. Each batch undergoes comprehensive analytical testing, including chromatographic purity (HPLC), identity confirmation (IR, MS), and residual solvent analysis, to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results and confirming compliance with relevant specifications.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. The material is hygroscopic (moisture-sensitive) and should be kept in a dry environment. For long-term storage, consider storing under inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 1.0%
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.