Description

Nintedanib Impurity E is a specified impurity of the active pharmaceutical ingredient Nintedanib, a tyrosine kinase inhibitor used in the treatment of idiopathic pulmonary fibrosis and certain cancers. This impurity is critical for pharmaceutical manufacturers to monitor and control to ensure the safety, efficacy, and regulatory compliance of the final drug product. It is primarily required by analytical laboratories, quality control departments, and R&D teams in the pharmaceutical industry for method development, validation, and as a reference standard.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the qualitative and quantitative analysis of Nintedanib drug substance and drug products.
• Method Development and Validation: Essential for developing and validating analytical methods, such as HPLC and LC-MS, to detect and quantify this specific impurity.
• Quality Control and Assurance: Serves as a benchmark in routine QC testing to ensure Nintedanib batches meet stringent purity specifications as per ICH guidelines.
• Regulatory Compliance and Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing necessary impurity profile data for drug approval and lifecycle management.
• Stability Studies: Used to monitor the formation of degradation products during forced degradation and long-term stability studies of Nintedanib.
• Research and Development: Facilitates process chemistry research to understand and minimize impurity formation during the synthesis of Nintedanib.

Basic Information

Product Name	Nintedanib Impurity E
CAS No.	262366-32-5
Molecular Formula	C31H33N5O4
Molecular Weight	539.63 g/mol
Synonyms	1H-Indole-6-carboxylic acid, 2,3-dihydro-3-[[[4-[methyl[(4-methyl-1-piperazinyl)carbonyl]amino]phenyl]amino]phenylmethylene]-2-oxo-, methyl ester; Methyl 3-((4-(N-methyl-4-methylpiperazine-1-carboxamido)phenyl)amino)(phenyl)methylene)-2-oxo-2,3-dihydro-1H-indole-6-carboxylate; Nintedanib Related Compound E; Nintedanib EP Impurity E; Nintedanib USP Impurity E; BIBF 1120 Impurity E; OFEV Impurity E
EINECS	Contact for details

Quality Control

Every batch of Nintedanib Impurity E is manufactured under controlled conditions and undergoes rigorous analytical testing to ensure identity, purity, and consistency. Our quality system is designed to meet the exacting standards of the pharmaceutical industry, with specifications aligned to relevant pharmacopoeial guidelines (e.g., USP, EP). A comprehensive Certificate of Analysis (COA) detailing batch-specific results for identity, assay, and impurity profile is provided with each shipment.

Storage

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

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.2%

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