Description

Nintedanib Impurity 67 is a specified impurity associated with the active pharmaceutical ingredient Nintedanib. This compound is critical for pharmaceutical research and development, serving as a key reference standard for analytical method development, validation, and quality control processes. It is essential for manufacturers and analytical laboratories focused on ensuring the purity, safety, and regulatory compliance of Nintedanib drug substances and products.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in Nintedanib API and finished dosage forms.
• Analytical Method Development: Used to develop and optimize chromatographic methods (e.g., HPLC, UPLC) for impurity profiling.
• Quality Control & Assurance: Employed in routine batch testing to monitor impurity levels against ICH Q3A/B guidelines.
• Regulatory Compliance & Filing: Critical for preparing regulatory submission documents (e.g., for FDA, EMA) to demonstrate comprehensive impurity control.
• Stability Studies: Used to track the formation and behavior of this impurity under various stress and long-term storage conditions.
• Process Chemistry Research: Aids in understanding and optimizing synthetic pathways to minimize the formation of this specific impurity.

Basic Information

Product Name	Nintedanib Impurity 67
CAS No.	59276-32-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Nintedanib Related Compound 67; Nintedanib EP Impurity 67; Nintedanib USP Impurity 67; BIBF 1120 Impurity 67; (Z)-Nintedanib 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; Vargatef Impurity 67; Ofev Impurity 67
EINECS	Contact for details

Quality Control

Our Nintedanib Impurity 67 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC purity analysis and spectroscopic identification (NMR, MS), to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results and confirming compliance with relevant specifications.

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 material is hygroscopic (moisture-sensitive) and must be kept under dry conditions to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (IR)	Spectrum conforms to reference
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% w/w

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