Description

Nintedanib Impurity 77 is a high-purity chemical reference standard used in the analytical profiling and quality control of the active pharmaceutical ingredient Nintedanib. This compound is critical for pharmaceutical manufacturers and research laboratories to ensure product safety, efficacy, and regulatory compliance by accurately identifying and quantifying this specific impurity. It is essential for method development, validation, and routine batch testing within the pharmaceutical and contract research organization (CRO) sectors.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the identification and quantification of Nintedanib Impurity 77 in drug substance and drug product.
• Analytical Method Development: Used to develop and optimize chromatographic methods (HPLC, UPLC) for impurity profiling.
• Quality Control & Assurance: Critical for routine batch release testing to ensure impurity levels are within ICH Q3A/B regulatory limits.
• Regulatory Submissions: Supports the preparation of Chemistry, Manufacturing, and Controls (CMC) documentation for regulatory filings (e.g., FDA, EMA).
• Stability Studies: Employed to monitor the formation of this impurity under various stress conditions and throughout shelf-life studies.
• Research & Development: Used in synthetic chemistry research to understand degradation pathways and improve synthesis processes.

Basic Information

Product Name	Nintedanib Impurity 77
CAS No.	56961-83-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Nintedanib Related Compound 77; Nintedanib EP Impurity G; Nintedanib USP Impurity; 1H-Indole-6-carboxylic acid, 2,3-dihydro-3-[[[4-[methyl[(4-methyl-1-piperazinyl)acetyl]amino]phenyl]amino]phenylmethylene]-2-oxo-, methyl ester; BIBF 1120 Impurity 77; OFEV Impurity 77; Vargatef Impurity 77
EINECS	Contact for details

Quality Control

Every batch of Nintedanib Impurity 77 is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC, NMR, and MS, to ensure identity, purity, and conformity with in-house specifications aligned with ICH guidelines. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment to support your regulatory and quality requirements.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider desiccants or inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (MS)	Conforms
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unknown impurity ≤ 1.0%
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.