Description

Nintedanib Impurity 52 is a designated impurity of the active pharmaceutical ingredient Nintedanib, a tyrosine kinase inhibitor. This compound is critical for pharmaceutical research and development, serving as a key reference standard for analytical method development, validation, and quality control. It is essential for ensuring the purity, safety, and efficacy of Nintedanib drug substances and products. This impurity is primarily utilized by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in the development and quality assurance of Nintedanib-based therapies.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Nintedanib Impurity 52 in drug substances and finished products.
• Analytical Method Development: Critical for developing and validating HPLC, UPLC, or LC-MS methods to monitor impurities in Nintedanib.
• Quality Control & Assurance (QC/QA): Employed in routine batch testing to ensure Nintedanib meets stringent pharmacopeial (e.g., USP, EP) and ICH Q3A/B guidelines for impurities.
• Stability Studies: Used to track the formation of this specific degradation product under various stress conditions (e.g., light, heat, humidity).
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., FDA, EMA) to establish impurity profiles and justify specification limits.
• Process Chemistry Research: Aids in understanding and optimizing the Nintedanib synthesis pathway to minimize the formation of this impurity.

Basic Information

Product Name	Nintedanib Impurity 52
CAS No.	2410284-89-6
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Nintedanib Related Compound 52; Nintedanib EP Impurity 52; Nintedanib USP Impurity 52; BIBF 1120 Impurity 52; (Z)-Nintedanib; (Z)-Methyl (3Z)-3-[[4-[N-Methyl-2-(4-methylpiperazin-1-yl)acetamido]phenylamino](phenyl)methylidene]-2-oxo-1H-indole-6-carboxylate; Vargatef Impurity 52; Ofev Impurity 52
EINECS	Contact for details

Quality Control

Our Nintedanib Impurity 52 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC purity analysis, identity confirmation (IR, MS), and residual solvent screening, to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with every shipment, detailing batch-specific results. We support compliance with ICH Q3A/B guidelines and can supply material suitable for use in regulated environments.

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. This material is strictly light-sensitive and must be protected from all light exposure during storage and handling to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 1.0% Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C

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