Description

Nintedanib Impurity 64 is a designated process-related impurity or degradation product associated with the active pharmaceutical ingredient Nintedanib. This compound is critical for pharmaceutical research and development, specifically for analytical method development, stability studies, and ensuring the quality and safety of the final drug product. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in the quality control and compliance of Nintedanib-based medications.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the qualitative and quantitative analysis of Nintedanib drug substance and drug products.
• Analytical Method Development and Validation: Essential for developing, optimizing, and validating chromatographic methods (e.g., HPLC, UPLC) to accurately detect and quantify this specific impurity.
• Stability and Forced Degradation Studies: Employed in studies to understand the degradation pathways of Nintedanib and to establish appropriate shelf-life and storage conditions.
• Quality Control and Batch Release: Serves as a system suitability standard in routine QC testing to ensure impurity profiles meet stringent pharmacopeial (e.g., USP, EP) and ICH guidelines.
• Regulatory Submissions: Critical for preparing regulatory documentation (e.g., CMC sections for FDA, EMA) to demonstrate comprehensive impurity profiling and control strategies.
• Research and Development: Used in R&D to study the chemical behavior, synthesis pathways, and purification processes of Nintedanib.

Basic Information

Item	Details
Product Name	Nintedanib Impurity 64
CAS No.	3840-28-6
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Nintedanib Related Compound 64; Nintedanib EP Impurity G; Nintedanib USP Impurity; 1H-Indole-3-carboxaldehyde, 2-[(4-{[(2-{4-[(2,6-Dichlorobenzoyl)amino]phenyl}ethyl)amino]carbonyl}-2-fluorophenyl)amino]-; BIBF 1120 Impurity 64; OFEV Impurity 64; Vargatef Impurity 64
EINECS	Contact for details

Quality Control

Every batch of Nintedanib Impurity 64 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing to ensure compliance with industry standards, including ICH Q3A/B guidelines and relevant pharmacopeial monographs. Comprehensive characterization is performed using advanced analytical techniques. Certificates of Analysis (COA) detailing purity, identity, and impurity profiles are available upon request.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccants or inert atmosphere conditions.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 1.0% Total impurities ≤ 3.0%
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.