Description

Nintedanib Impurity 65 is a designated process-related impurity and reference standard used in the analytical profiling of the active pharmaceutical ingredient Nintedanib. This compound is critical for ensuring the quality, safety, and efficacy of the final drug product by enabling accurate identification and quantification during pharmaceutical development and manufacturing. It is an essential material for analytical chemists and quality control laboratories in the pharmaceutical industry, particularly those involved in method validation, stability studies, and regulatory compliance for Nintedanib-based therapies.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for the qualitative and quantitative analysis of Nintedanib drug substance and drug products.
• Method Development and Validation (HPLC/LC-MS): Critical for developing, optimizing, and validating chromatographic methods to monitor and control impurity levels in accordance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Stability Indicating Method: Used in forced degradation and long-term stability studies to track the formation of this specific impurity over time and under various stress conditions.
• Quality Control and Batch Release: Serves as a system suitability component and an external standard in routine QC testing to ensure batch-to-batch consistency and compliance with regulatory specifications.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., FDA, EMA) to establish impurity profiles, justify specification limits, and demonstrate control of the manufacturing process.
• Research and Development: Utilized in synthetic route development and process optimization to understand and minimize the formation of this impurity.

Basic Information

Product Name	Nintedanib Impurity 65
CAS No.	73569-69-4
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Nintedanib Related Compound 65; Nintedanib EP Impurity G; 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; BIBF 1120 Impurity 65; Vargatef Impurity 65; Ofev Impurity 65
EINECS	Contact for details

Quality Control

Every batch of Nintedanib Impurity 65 is manufactured and controlled under a strict quality management system. The material undergoes comprehensive analytical testing, including chromatographic purity (HPLC), identity confirmation (IR, MS), and residual solvent analysis to ensure it meets the high standards required for use as a pharmaceutical reference standard. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, and is available for review upon request.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C, in a dry environment. Keep the container sealed to protect from moisture.

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 ≤ 2.0% Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0% w/w

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