Description

Lenvatinib Impurity P is a designated impurity reference standard used in the pharmaceutical development 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 enabling accurate identification and quantification of process-related impurities. It is an essential material for analytical method development, validation, and routine batch release testing in pharmaceutical R&D and quality assurance laboratories.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the identification and quantification of Lenvatinib Impurity P in API and finished drug products.
• Analytical Method Development & Validation: Critical for developing and validating stability-indicating HPLC, UPLC, or LC-MS methods for Lenvatinib.
• Quality Control & Batch Release: Used in routine QC testing to monitor impurity profiles and ensure compliance with ICH Q3A/B guidelines and regulatory specifications.
• Stability Studies: Employed to track the formation and levels of this specific impurity under various stress conditions (thermal, photolytic, hydrolytic).
• Regulatory Submissions: Provides essential data for Drug Master Files (DMFs), Investigational New Drug (IND), and New Drug Application (NDA) filings to global health authorities (FDA, EMA, PMDA).
• Process Chemistry Research: Aids in understanding and optimizing the Lenvatinib synthesis pathway to minimize the formation of this impurity.

Basic Information

Product Name	Lenvatinib Impurity P
CAS No.	2143930-77-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Lenvatinib Related Compound P; Lenvatinib EP Impurity P; Lenvatinib USP Impurity P; 4-[3-Chloro-4-[(cyclopropylcarbamoyl)amino]phenoxy]-7-methoxyquinoline-6-carboxamide impurity; E7080 Impurity P; Lenvima Impurity P
EINECS	Contact for details

Quality Control

Our Lenvatinib Impurity P is manufactured under strict quality systems. Each batch undergoes comprehensive analytical testing, including HPLC purity, identity confirmation (IR, MS), and residual solvent analysis, to ensure it meets the stringent requirements for a pharmaceutical reference standard. A comprehensive Certificate of Analysis (COA) with batch-specific data is provided, supporting compliance with cGMP and ICH guidelines.

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 under inert conditions or in a desiccator after opening to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (MS)	Mass spectrum conforms to structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any single unknown impurity ≤ 1.0%
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.