Description

Nintedanib Impurity 15 is a designated impurity of the active pharmaceutical ingredient Nintedanib, a tyrosine kinase inhibitor. This compound is critical for pharmaceutical research and development, serving as a reference standard for analytical method development, validation, and quality control. It is essential for laboratories and manufacturers involved in the synthesis, purification, and regulatory compliance of Nintedanib drug substances and products.

Application

• Primary use as a pharmaceutical reference standard for the identification and quantification of impurities in Nintedanib API and finished dosage forms.
• Critical component in analytical method development and validation (HPLC, UPLC, LC-MS) to ensure specificity and accuracy.
• Used in stability studies to monitor impurity profiles and degradation pathways of Nintedanib under various conditions.
• Essential for quality control and assurance processes in pharmaceutical manufacturing to meet ICH, USP, and EP guidelines.
• Supports regulatory submissions (e.g., ANDA, NDA) by providing necessary impurity characterization data.
• Valuable for research and development of synthetic routes and purification processes for Nintedanib.

Basic Information

Product Name	Nintedanib Impurity 15
CAS No.	1027407-75-5
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Nintedanib Related Compound 15; Nintedanib EP Impurity 15; Nintedanib USP Impurity 15; BIBF 1120 Impurity 15; 1H-Indole-6-carboxylic acid, 2,3-dihydro-3-[[[4-(methylamino)-1-oxo-2-buten-1-yl]amino]phenylmethylene]-2-oxo-, (3Z)-; (Z)-3-((4-(Methylamino)-4-oxobut-2-en-1-ylidene)-2-oxo-2,3-dihydro-1H-indol-6-yl)carboxylic acid; Vargatef Impurity 15; Ofev Impurity 15
EINECS	Contact for details

Quality Control

Our Nintedanib Impurity 15 is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing to ensure identity, purity, and consistency, meeting the stringent requirements for pharmaceutical reference standards. A comprehensive Certificate of Analysis (COA) is provided, detailing results from HPLC, NMR, and MS analyses. Our quality commitment aligns with cGMP principles and supports compliance with ICH Q3A/B, USP, and EP monographs.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or Certificate of Analysis. Keep the container in a dry, cool, and well-ventilated area. Handle and store in accordance with good laboratory practices.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (MS)	Conforms
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual 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.