Description

Nintedanib Impurity D is a specified impurity and a key chemical reference standard used in the 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 serving as a benchmark in analytical testing. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in the development, production, and quality assurance of Nintedanib-based medications.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Nintedanib Impurity D in drug substance and drug product testing.
• Analytical Method Development & Validation: Essential for developing, validating, and verifying High-Performance Liquid Chromatography (HPLC) and other chromatographic methods in quality control laboratories.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., for FDA, EMA) by providing necessary impurity profiles and ensuring compliance with ICH Q3A(R2) and Q3B(R2) guidelines on impurities.
• Stability Studies: Employed to monitor impurity levels during forced degradation and long-term stability studies of Nintedanib API and formulations.
• Process Chemistry & Optimization: Used by R&D and process chemists to identify, track, and control the formation of this impurity during the synthesis and purification of Nintedanib.
• Quality Assurance/Quality Control (QA/QC): A critical component for routine batch release testing to ensure impurity specifications are met.

Basic Information

Product Name	Nintedanib Impurity D
CAS No.	334950-70-8
Molecular Formula	C31H33N5O4
Molecular Weight	539.63 g/mol
Synonyms	Nintedanib Related Compound D; 1H-Indole-6-carboxylic acid, 2,3-dihydro-3-[[[4-[methyl[(4-methyl-1-piperazinyl)carbonyl]amino]phenyl]amino]phenylmethylene]-2-oxo-, methyl ester; Methyl 3-((4-(N-methyl-4-methylpiperazine-1-carboxamido)phenyl)amino)(phenyl)methyl)-2-oxo-2,3-dihydro-1H-indole-6-carboxylate; BIBF 1120 Impurity D; Vargatef Impurity D; Ofev Impurity D
EINECS	Contact for details

Quality Control

Our Nintedanib Impurity D is manufactured under strict quality systems suitable for use as a pharmaceutical reference standard. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation (IR, MS), to ensure compliance with stringent industry standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive); the container must be kept tightly sealed in a dry environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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