Description

Nintedanib Impurity 61 CAS NO 109682-56-6 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the active pharmaceutical ingredient Nintedanib, a tyrosine kinase inhibitor. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions involved in drug development, quality control, and impurity profiling.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Nintedanib drug substance and finished products.
• Analytical Method Development & Validation: Essential for developing, calibrating, and validating HPLC, UPLC, or LC-MS methods for impurity analysis.
• Quality Control & Assurance (QC/QA): Serves as a system suitability standard in routine quality control testing to monitor batch-to-batch consistency.
• Regulatory Compliance & Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing necessary impurity data for drug master files (DMFs) and investigational new drug (IND) applications.
• Stability Studies: Employed to track the formation and level of this specific impurity during forced degradation and long-term stability studies of Nintedanib.
• Research & Development: Used in pharmacokinetic and metabolic studies to understand the degradation pathways of Nintedanib.

Basic Information

Product Name	Nintedanib Impurity 61
CAS No.	109682-56-6
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Nintedanib Related Compound 61; Nintedanib EP Impurity 61; Nintedanib USP Impurity 61; Nintedanib Process Impurity; 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
EINECS	Contact for details

Quality Control

Every batch of Nintedanib Impurity 61 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques like HPLC and LC-MS to ensure compliance with pharmacopeial standards (USP/EP/ICH). A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each 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 (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified 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.