Description

Nintedanib Impurity 76 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 ensuring the purity, safety, and efficacy of Nintedanib drug substances and products. This high-purity standard is primarily needed by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in the production and testing of this important therapeutic agent.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Nintedanib Impurity 76 in drug substances and finished products.
• Analytical Method Development: Critical for developing and optimizing chromatographic methods, such as HPLC and UPLC, for impurity profiling.
• Quality Control & Assurance: Employed in routine QC testing to monitor impurity levels and ensure batch-to-batch consistency and compliance with ICH guidelines.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., FDA, EMA) to establish impurity thresholds and justify specifications.
• Stability Studies: Used to track the formation of this specific impurity under various stress conditions to determine product shelf-life.
• Process Chemistry Research: Aids in understanding and optimizing the synthesis pathway of Nintedanib to minimize the formation of this impurity.

Basic Information

Product Name	Nintedanib Impurity 76
CAS No.	56961-85-4
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Nintedanib Related Compound 76; Nintedanib EP Impurity G; 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-((4-(N-methyl-2-(4-methylpiperazin-1-yl)acetamido)phenyl)amino)(phenyl)methylene)-2-oxo-2,3-dihydro-1H-indole-6-carboxylate; BIBF 1120 Impurity 76; Vargatef Impurity 76; Ofev Impurity 76
EINECS	Contact for details

Quality Control

Our Nintedanib Impurity 76 is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation via spectroscopic methods (NMR, MS), to ensure it meets the high standards required for pharmaceutical reference materials. Certificates of Analysis (COA) containing batch-specific data are provided and traceable to primary standards where applicable, supporting compliance with ICH Q3A, Q3B, and relevant pharmacopeial guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C, in a dry environment. Handle and store in accordance with good laboratory practices.

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)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C

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