Description

Lenvatinib Impurity 11 is a designated impurity standard used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) Lenvatinib. This compound is critical for ensuring the purity, safety, and efficacy of the final drug product by serving as a reference marker in chromatographic methods. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in the development and production of Lenvatinib-based oncology treatments.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Lenvatinib Impurity 11 in API and finished drug products.
• Method Development and Validation: Essential for developing, optimizing, and validating stability-indicating HPLC or UPLC methods for Lenvatinib.
• Quality Control & Batch Release: Employed in routine QC testing to monitor impurity levels and ensure compliance with ICH Q3A/B guidelines and regulatory specifications.
• Stability Studies: Used to track the formation of this specific impurity under various stress conditions (heat, light, humidity) as part of forced degradation and shelf-life studies.
• Regulatory Submissions: Provides necessary data on impurity profiles for drug master files (DMF), investigational new drug (IND) applications, and new drug applications (NDA).
• Research and Development: Supports process chemistry research to understand and minimize the formation of this impurity during API synthesis.

Basic Information

Item	Detail
Product Name	Lenvatinib Impurity 11
CAS No.	2244924-46-5
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Lenvatinib Related Compound 11; Lenvatinib EP Impurity J; Lenvatinib USP Impurity; 4-[3-Chloro-4-[(cyclopropylcarbamoyl)amino]phenoxy]-7-methoxyquinoline-6-carboxamide impurity; E7080 Impurity 11; Lenvima Impurity 11
EINECS	Contact for details

Quality Control

Every batch of Lenvatinib Impurity 11 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing to ensure compliance with industry standards, including identity confirmation by spectroscopic methods (IR, NMR, MS) and purity determination by advanced chromatographic techniques (HPLC, UPLC). Certificates of Analysis (COA) are available upon request, providing full traceability and detailed analytical results.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (typically 15-25°C). This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccants or inert atmosphere conditions.

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 ≤ 1.0% Total impurities ≤ 3.0%
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.