Description

Nintedanib Impurity 50 is a high-purity chemical reference standard used in the pharmaceutical development and quality control processes. This compound is critical for ensuring the safety and efficacy of the active pharmaceutical ingredient (API) Nintedanib by accurately identifying and quantifying related substances. It is an essential tool for analytical chemists and quality assurance professionals in pharmaceutical R&D and manufacturing. The product is supplied with comprehensive analytical data to support regulatory filings and internal quality standards.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the identification and quantification of impurities in Nintedanib API.
• Analytical Method Development & Validation: Used to develop, optimize, and validate HPLC, UPLC, or LC-MS methods for impurity profiling.
• Quality Control & Batch Release: Critical for in-process testing and final release testing of Nintedanib drug substance and drug products to ensure compliance with ICH guidelines.
• Regulatory Submissions: Supports the preparation of regulatory documents (e.g., CMC sections for FDA, EMA) by providing characterized impurity data.
• Stability Studies: Employed to monitor the formation of this specific impurity under various stress conditions and throughout shelf-life studies.
• Research & Development: Used in synthetic chemistry research to understand degradation pathways and to develop purification processes for the API.

Basic Information

Product Name	Nintedanib Impurity 50
CAS No.	2410284-90-9
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Nintedanib Related Compound 50; Nintedanib EP Impurity 50; Nintedanib USP Impurity 50; Nintedanib Process 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 50; OFEV Impurity 50; Vargatef Impurity 50
EINECS	Contact for details

Quality Control

Every batch of Nintedanib Impurity 50 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing to ensure compliance with industry standards, including relevant ICH Q3A/B guidelines for impurities. Comprehensive characterization is performed using advanced techniques such as HPLC, LC-MS, NMR, and IR. Certificates of Analysis (COA) detailing purity, identity, and impurity profiles are available upon request to support your regulatory and quality needs.

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. For long-term storage, consider desiccants or inert atmosphere to preserve stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 1.0% Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.5%

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