Description

Lenvatinib Impurity 14 is a designated process-related impurity and degradation product of the active pharmaceutical ingredient Lenvatinib. This compound is critical for pharmaceutical research and development, serving as a key reference standard for analytical method development, validation, and quality control. It is essential for manufacturers, analytical laboratories, and regulatory bodies involved in ensuring the purity, safety, and efficacy of Lenvatinib drug substances and products.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the identification and quantification of impurities in Lenvatinib API and finished dosage forms.
• Analytical Method Development: Crucial for developing and optimizing chromatographic methods (HPLC, UPLC) to separate and detect related substances.
• Quality Control & Stability Studies: Used in routine batch testing and forced degradation studies to monitor impurity profiles and ensure product stability over time.
• Regulatory Compliance & Filing: Supports the preparation of regulatory submission documents (e.g., for FDA, EMA) by providing necessary impurity characterization data.
• Process Chemistry Research: Aids in understanding the formation pathways of this impurity during Lenvatinib synthesis, enabling process optimization.
• Pharmacopoeial Testing: Potential use in testing to meet monograph specifications set by pharmacopoeias like USP or EP.

Basic Information

Product Name	Lenvatinib Impurity 14
CAS No.	417719-45-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Lenvatinib Related Compound 14; Lenvatinib EP Impurity J; Lenvatinib USP Impurity; 4-[3-Chloro-4-[[(3-fluorophenyl)carbamoyl]amino]phenoxy]-7-methoxyquinoline-6-carboxamide; E7080 Impurity 14; Lenvima Impurity 14
EINECS	Contact for details

Quality Control

Our Lenvatinib Impurity 14 is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including identification by spectroscopic methods (IR, NMR, MS), purity assessment by HPLC, and control of residual solvents and moisture. A detailed Certificate of Analysis (COA) is provided with each shipment, confirming compliance with our stringent specifications.

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 material is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity.

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%

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