Description

Nintedanib Impurity E (Intedanib Impurity E) CAS NO 1610881-60-1 is a high-purity reference standard used for the analytical profiling and quality control of the active pharmaceutical ingredient Nintedanib. This compound is critical for pharmaceutical manufacturers and research laboratories to ensure product safety, efficacy, and regulatory compliance by accurately identifying and quantifying this specific process-related impurity. It is an essential material for method development, validation, and stability studies within the pharmaceutical development lifecycle.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for the quality control of Nintedanib drug substance and drug products.
• Analytical Method Development & Validation: Used to develop, optimize, and validate HPLC, UPLC, or LC-MS methods for impurity detection and separation.
• Stability Indicating Studies: Employed in forced degradation and long-term stability studies to monitor the formation of this impurity over time and under various stress conditions.
• Regulatory Compliance & Documentation: Essential for preparing regulatory submission documents (e.g., for FDA, EMA) that require detailed impurity characterization and control strategies.
• Pharmacopoeial Testing: Supports testing in compliance with pharmacopoeial monographs (e.g., USP, EP) that specify limits for known and unknown impurities.
• Process Chemistry Research: Used by R&D chemists to understand and optimize synthesis pathways to minimize the formation of this specific impurity.

Basic Information

Product Name	Nintedanib Impurity E
CAS No.	1610881-60-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Intedanib Impurity E; Nintedanib Related Compound E; Methyl N-[4-[(6,7-Dimethoxy-4-quinazolinyl)oxy]phenyl]-N-methyl-L-alaninate; BIBF 1120 Impurity E; OFEV Impurity E; Vargatef Impurity E; 1H-Indole-6-carboxylic acid, 2,3-dihydro-3-[[[4-[methyl[(4-methyl-1-piperazinyl)acetyl]amino]phenyl]amino]phenylmethylene]-2-oxo-, ethyl ester
EINECS	Contact for details

Quality Control

Every batch of Nintedanib Impurity E is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques such as HPLC, GC, MS, and NMR to ensure compliance with industry standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. We support compliance with ICH Q3A/B guidelines and can supply materials suitable for use in regulatory submissions.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the product label or COA. Keep the container in a dry, cool, and well-ventilated place. For long-term storage, consider storing under inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unknown impurity ≤ 1.0% Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0%

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