Description

Lenvatinib Impurity 8 is a specified organic impurity associated with the active pharmaceutical ingredient Lenvatinib, a multi-kinase inhibitor. This compound is critical for pharmaceutical research and development, serving as a key reference standard for analytical method development, validation, and quality control processes. It is primarily required by analytical chemists, quality assurance professionals, and R&D scientists in the pharmaceutical and biotechnology sectors to ensure the purity, safety, and efficacy of Lenvatinib drug substances and products.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Lenvatinib active pharmaceutical ingredient (API) and finished dosage forms.
• Analytical Method Development: Essential for developing and optimizing chromatographic methods, such as HPLC and UPLC, for impurity profiling.
• Quality Control & Assurance: Employed in routine batch testing to monitor impurity levels and ensure compliance with ICH Q3A/B guidelines and regulatory submission requirements.
• Stability Studies: Used to track the formation of degradation products under various stress conditions (e.g., heat, light, humidity) as part of drug stability testing.
• Regulatory Compliance: Supports the preparation of regulatory documentation (e.g., CMC sections for FDA, EMA) by providing necessary impurity characterization data.
• Process Chemistry Research: Aids in understanding and controlling impurity formation during the synthesis and purification stages of Lenvatinib manufacturing.

Basic Information

Product Name	Lenvatinib Impurity 8
CAS No.	1882873-21-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Lenvatinib Related Compound 8; Lenvatinib Impurity C; 4-[3-Chloro-4-[[(cyclopropylamino)carbonyl]amino]phenoxy]-7-methoxy-6-quinolinecarboxamide Impurity; E7080 Impurity 8; Lenvima Impurity 8; Lenvatinib EP Impurity C; Lenvatinib USP Impurity
EINECS	Contact for details

Quality Control

Our Lenvatinib Impurity 8 is manufactured under strict quality systems to ensure high purity and batch-to-batch consistency suitable for use as a reference standard. Each batch undergoes comprehensive analytical characterization using techniques such as HPLC, GC, MS, and NMR to confirm identity and purity. Certificates of Analysis (COA) are provided, detailing all test results against established specifications. Our quality commitment aligns with cGMP principles and relevant pharmacopeial guidelines (e.g., USP, EP) for pharmaceutical impurities.

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. For long-term storage, consider storing under an inert atmosphere.

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)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unknown impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0% w/w

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