Description

Lenvatinib Impurity 12 CAS NO 2250242-56-7 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 primarily utilized by professionals in pharmaceutical R&D, quality assurance, and analytical chemistry for method development, validation, and batch release testing.

Application

• Pharmaceutical Reference Standard for the identification and quantification of impurities in Lenvatinib API and finished dosage forms.
• Method Development and Validation in analytical laboratories for HPLC, UPLC, and LC-MS techniques.
• Quality Control & Assurance (QC/QA) to monitor impurity profiles and ensure batch-to-batch consistency in manufacturing.
• Regulatory Compliance and Filing, supporting documentation for regulatory submissions to agencies like the FDA, EMA, and PMDA.
• Stability Studies to track the formation of degradation products under various stress conditions.
• Research and Development for studying the degradation pathways and chemical behavior of Lenvatinib.

Basic Information

Product Name	Lenvatinib Impurity 12
CAS No.	2250242-56-7
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Lenvatinib Related Compound 12; Lenvatinib EP Impurity 12; Lenvatinib USP Impurity 12; Lenvatinib Degradant; 4-[3-Chloro-4-[(cyclopropylcarbamoyl)amino]phenoxy]-7-methoxyquinoline-6-carboxamide impurity; E7080 Impurity 12
EINECS	Contact for details

Quality Control

Our Lenvatinib Impurity 12 is manufactured under strict quality systems to ensure high purity and traceability. Each batch is accompanied by a comprehensive Certificate of Analysis (COA) detailing purity, identity, and impurity profiles. Our quality protocols are designed to meet the stringent requirements of pharmaceutical reference standards, supporting compliance with ICH Q3A/B, USP, and EP guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 2.0% Total impurities ≤ 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.