Description

Nintedanib Impurity 69 is a designated process-related impurity and reference standard used in the pharmaceutical development and quality control of the active pharmaceutical ingredient (API) Nintedanib. This compound is critical for ensuring the purity, safety, and efficacy of the final drug product by enabling accurate identification and quantification during analytical testing. It is an essential material for pharmaceutical R&D laboratories, quality assurance/quality control (QA/QC) units, and contract research organizations (CROs) involved in the synthesis and validation of Nintedanib.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the calibration of analytical equipment (HPLC, LC-MS) in method development and validation.
• Analytical Method Development: Serves as a critical component for developing and optimizing chromatographic methods to separate and quantify impurities in Nintedanib API.
• Quality Control & Batch Release: Employed in routine QA/QC testing to monitor and control the levels of this specific impurity, ensuring compliance with ICH Q3A/B guidelines.
• Stability Studies: Used to track the formation and degradation of impurities in Nintedanib drug substance and products under various storage conditions.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., FDA, EMA) to demonstrate comprehensive impurity profiling and control strategies.
• Process Chemistry Research: Aids chemists in understanding and optimizing the Nintedanib synthesis pathway to minimize the formation of this impurity.

Basic Information

Product Name	Nintedanib Impurity 69
CAS No.	59276-34-5
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Nintedanib Related Compound 69; Nintedanib EP Impurity 69; Nintedanib USP Impurity 69; BIBF 1120 Impurity 69; (Z)-N-(4-(3-((4-Methylpiperazin-1-yl)methyl)benzyloxy)phenyl)-3-(4-(morpholine-4-carbonyl)phenyl)acrylamide; Vargatef Impurity 69; Ofev Impurity 69
EINECS	Contact for details

Quality Control

Our Nintedanib Impurity 69 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 our quality systems support compliance with cGMP and ICH guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. The material is hygroscopic (moisture-sensitive) and should be kept in a dry environment. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (IR)	Conforms
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual 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.