Description

Lenvatinib Impurity G CAS NO 417714-14-8 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for pharmaceutical quality control, enabling the accurate identification, quantification, and monitoring of this specific impurity during the development and manufacturing of the active pharmaceutical ingredient (API) Lenvatinib. It is an essential material for analytical laboratories, research institutions, and pharmaceutical companies focused on ensuring product safety, efficacy, and regulatory compliance.

Application

• Pharmaceutical Impurity Profiling and Characterization: Primary use as a certified reference standard for method development and validation in HPLC, UPLC, and LC-MS systems.
• Quality Control and Assurance (QC/QA): Used to establish acceptance criteria and monitor impurity levels in Lenvatinib API and finished drug products to meet ICH guidelines.
• Regulatory Compliance and Submission: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing definitive impurity identification data.
• Stability Studies: Employed to track the formation and growth of this impurity under various stress conditions to determine drug shelf-life.
• Process Chemistry Research: Aids in the optimization of Lenvatinib synthesis and purification processes by identifying and quantifying process-related impurities.
• Academic and Contract Research: Serves as a key reagent in pharmacological and metabolic studies related to Lenvatinib.

Basic Information

Product Name	Lenvatinib Impurity G
CAS No.	417714-14-8
Molecular Formula	C21H19ClN4O4
Molecular Weight	426.86 g/mol
Synonyms	4-[3-Chloro-4-[[(3-fluorophenyl)carbamoyl]amino]phenoxy]-7-methoxyquinoline-6-carboxamide; Lenvatinib Related Compound G; E7080 Impurity G; Lenvima Impurity G; (4-{3-Chloro-4-[(3-fluorophenyl)carbamoylamino]phenoxy}-7-methoxyquinoline-6-carboxamide); UNII-9V8I8UQ81L; Lenvatinib EP Impurity G; Lenvatinib USP Impurity G
EINECS	Contact for details

Quality Control

Every batch of Lenvatinib Impurity G is manufactured and analyzed under strict quality management systems. The product undergoes rigorous identity confirmation, purity assay, and impurity profiling using advanced chromatographic (HPLC, UPLC) and spectroscopic (NMR, MS) techniques 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, analytical methods, and traceability.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F), in a dry environment. The container should be kept sealed in a cool, well-ventilated area away from incompatible materials.

Specification

Item	Specification
Appearance	White to off-white solid
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 single unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0% w/w

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