Description

Nintedanib Impurity I CAS NO 334951-61-0 is a specified impurity of the active pharmaceutical ingredient Nintedanib, a tyrosine kinase inhibitor. This compound is critical for pharmaceutical development and quality control, serving as a reference standard to ensure the purity and safety of the final drug product. It is primarily required by analytical laboratories, research institutions, and pharmaceutical manufacturers involved in the synthesis, process development, and regulatory compliance of Nintedanib.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Nintedanib Impurity I in drug substance and drug product analysis.
• Method Development and Validation: Essential for developing and validating analytical methods, such as HPLC and UPLC, to monitor impurities during the manufacturing process.
• Quality Control & Assurance (QC/QA): A critical tool for in-process testing and release testing of Nintedanib to meet pharmacopeial standards (e.g., USP, EP, ICH Q3A/B).
• Stability Studies: Employed to track the formation of this specific degradation product under various stress conditions to establish drug shelf life.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., FDA, EMA) to demonstrate thorough impurity profiling and control strategies.
• Research and Development: Used in synthetic chemistry research to understand formation pathways and develop purification processes to minimize this impurity.

Basic Information

Product Name	Nintedanib Impurity I
CAS No.	334951-61-0
Molecular Formula	C31H33N5O4
Molecular Weight	539.63 g/mol
Synonyms	Nintedanib Related Compound I; BIBF 1120 Impurity I; Methyl 3-({[methyl({4-[(4-methylpiperazin-1-yl)methyl]phenyl})amino]methyl})benzoate; 3-({[Methyl({4-[(4-methylpiperazin-1-yl)methyl]phenyl})amino]methyl})benzoic acid methyl ester; Nintedanib Process Impurity; Nintedanib Intermediate Derivative; Vargatef Impurity I; OFEV Impurity I
EINECS	Contact for details

Quality Control

Our Nintedanib Impurity I is manufactured and controlled under strict quality systems. Each batch undergoes comprehensive analytical testing, including identification by spectroscopic methods (IR, NMR, MS), purity determination by HPLC, and control of related substances. We provide a detailed Certificate of Analysis (COA) with each shipment, which includes batch-specific results and confirms compliance with in-house specifications aligned with ICH guidelines. Certificates are available upon request.

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 product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccants.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
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.