Description

Nintedanib Impurity 26/(3Z)-2,3-Dihydro-2-Oxo-3-(Phenyl-1-Piperidinylmethylene)-1H-Indole-6-Carboxylic Acid Methyl Ester is a high-purity chemical reference standard critical for pharmaceutical research and development. This compound serves as a specified impurity in the quality control and regulatory compliance of the active pharmaceutical ingredient (API) Nintedanib, a tyrosine kinase inhibitor. It is essential for analytical chemists and quality assurance professionals in pharmaceutical manufacturing to ensure product safety, efficacy, and adherence to stringent pharmacopeial standards such as ICH guidelines.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for the identification and quantification of Nintedanib Impurity 26 in API batches.
• Analytical Method Development & Validation (HPLC/LC-MS): Used to develop, calibrate, and validate chromatographic methods for impurity profiling.
• Quality Control & Assurance (QC/QA): Critical for routine batch release testing to monitor and control impurity levels within ICH-specified limits.
• Regulatory Compliance & Documentation: Supports the preparation of regulatory submission dossiers (e.g., for FDA, EMA) by providing characterized impurity data.
• Stability Studies: Employed as a marker to track impurity formation in Nintedanib drug products under various storage conditions.
• Research & Development: Used in synthetic chemistry research to study the degradation pathways and metabolism of Nintedanib.

Basic Information

Product Name	Nintedanib Impurity 26/(3Z)-2,3-Dihydro-2-Oxo-3-(Phenyl-1-Piperidinylmethylene)-1H-Indole-6-Carboxylic Acid Methyl Ester
CAS No.	2102162-79-6
Molecular Formula	C22H20N2O4
Molecular Weight	376.41 g/mol
Synonyms	(3Z)-3-[(Phenyl)(1-piperidinyl)methylene]-2,3-dihydro-2-oxo-1H-indole-6-carboxylic acid methyl ester; Methyl (3Z)-3-[(phenyl)(piperidin-1-yl)methylene]-2-oxo-2,3-dihydro-1H-indole-6-carboxylate; Nintedanib Impurity 26; Nintedanib Related Compound 26; BIBF 1120 Impurity 26; (Z)-Methyl 3-((phenyl)(piperidin-1-yl)methylene)-2-oxoindoline-6-carboxylate; OFEV Impurity 26; Vargatef Impurity 26
EINECS	Contact for details

Quality Control

Our Nintedanib Impurity 26 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC purity analysis, spectroscopic identification (IR, NMR, MS), and residual solvent screening, to ensure compliance with pharmaceutical reference standard requirements. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with every shipment, supporting traceability and regulatory compliance.

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 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 (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0% w/w
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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