Description

Lenvatinib Impurity 5 CAS NO 1788901-86-9 is a high-purity chemical reference standard used for the analytical profiling and quality control of the active pharmaceutical ingredient Lenvatinib. This impurity is critical for pharmaceutical manufacturers and research laboratories to ensure drug safety, efficacy, and regulatory compliance by accurately identifying and quantifying related substances. It is an essential component for method development, validation, and stability studies in the production of oncology therapeutics.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for the quality control of Lenvatinib Mesylate API and finished drug products.
• Analytical Method Development & Validation: Used in HPLC, UPLC, and LC-MS methods to establish specificity, accuracy, and detection limits for impurity profiling.
• Stability Studies: Employed to monitor the formation of degradation products under various stress conditions (heat, light, humidity) as per ICH guidelines.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., FDA, EMA) by providing authentic samples for impurity identification and qualification in drug dossiers.
• Research & Development: Serves as a key intermediate or by-product for studying the synthesis pathway, metabolism, and degradation mechanisms of Lenvatinib.
• Contract Research & Testing Laboratories: Essential for third-party labs providing analytical services to the pharmaceutical industry.

Basic Information

Product Name	Lenvatinib Impurity 5
CAS No.	1788901-86-9
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Lenvatinib Related Compound 5; Lenvatinib Impurity; E7080 Impurity 5; 4-[3-Chloro-4-[(cyclopropylcarbamoyl)amino]phenoxy]-7-methoxyquinoline-6-carboxamide Impurity; Lenvima Impurity; Lenvatinib Degradation Product; Lenvatinib Process Impurity
EINECS	Contact for details

Quality Control

Every batch of Lenvatinib Impurity 5 is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC purity determination and spectroscopic identification (NMR, MS), to ensure compliance with pharmaceutical reference standard requirements. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for identity, purity, and impurities. We support compliance with ICH Q3A/B and GMP guidelines for impurities in new drug substances.

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 nature, the container must be kept tightly sealed in a dry environment to prevent moisture absorption. 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)	Single unknown impurity ≤ 1.0% Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C

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