Description

Nintedanib Impurity J CAS NO 1139457-10-5 is a specified organic impurity associated with the active pharmaceutical ingredient Nintedanib. This compound is critical for analytical method development, stability studies, and ensuring the quality and safety of the final drug product. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for research, quality control, and compliance purposes.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Nintedanib Impurity J in drug substances and finished products.
• Analytical Method Development and Validation: Essential for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods to monitor impurities in Nintedanib.
• Stability and Forced Degradation Studies: Employed to understand the degradation pathways of Nintedanib and to establish appropriate shelf-life and storage conditions.
• Quality Control and Batch Release: Serves as a system suitability standard in routine QC testing to ensure impurity levels are within International Council for Harmonisation (ICH) guidelines.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., with FDA, EMA) to demonstrate thorough impurity profiling and control strategies.
• Research and Development: Used in synthetic chemistry research to study the formation and fate of this impurity during the manufacturing process of Nintedanib.

Basic Information

Item	Details
Product Name	Nintedanib Impurity J
CAS No.	1139457-10-5
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Nintedanib Related Compound J; Nintedanib EP Impurity J; Nintedanib USP Impurity J; BIBF 1120 Impurity J; 1H-Indole-6-carboxylic acid, 2,3-dihydro-3-[[[4-[methyl[(4-methyl-1-piperazinyl)acetyl]amino]phenyl]amino]phenylmethylene]-2-oxo-, methyl ester; Methyl 3-((Z)-(4-(N-methyl-2-((4-methylpiperazin-1-yl)acetamido)anilino)(phenyl)methylene)-2-oxo-2,3-dihydro-1H-indole-6-carboxylate
EINECS	Contact for details

Quality Control

Our Nintedanib Impurity J is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including identification by spectroscopic methods (IR, NMR, MS) and purity determination by HPLC, to ensure it meets the high standards required for pharmaceutical impurity analysis. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with every shipment.

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 (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unknown impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
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.