Description

Nintedanib Impurity 93 is a high-purity chemical reference standard specifically identified for pharmaceutical analysis and development. This compound is critical for ensuring the quality, safety, and regulatory compliance of the active pharmaceutical ingredient (API) Nintedanib, a tyrosine kinase inhibitor. It is primarily required by analytical laboratories, quality control (QC) departments, and research & development (R&D) teams within the global pharmaceutical and biotechnology sectors for method validation and impurity profiling.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the qualitative and quantitative analysis of Nintedanib API.
• Method Development and Validation (HPLC/LC-MS): Essential for developing, validating, and verifying chromatographic methods to monitor and control impurity levels.
• Quality Control and Batch Release: Employed in routine QC testing to ensure Nintedanib drug substances and products meet stringent pharmacopeial (e.g., USP, EP) and ICH guidelines.
• Stability Studies: Used to identify and quantify degradation products formed during forced degradation and long-term stability studies of Nintedanib formulations.
• Regulatory Submissions: Provides necessary impurity characterization data for regulatory filings (e.g., FDA, EMA) to support drug approval processes.
• Research on Degradation Pathways: Aids in research to understand the chemical degradation pathways of Nintedanib under various conditions.

Basic Information

Product Name	Nintedanib Impurity 93
CAS No.	2130844-77-6
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Nintedanib Related Compound 93; Nintedanib EP Impurity J; Nintedanib USP Impurity; BIBF 1120 Impurity 93; 1H-Indole-6-carboxamide, N-[4-[(3-[(4-methyl-1-piperazinyl)methyl]phenyl)amino]-5-(trifluoromethyl)-2-pyrimidinyl]-; (Z)-Nintedanib Impurity; Nintedanib Process Impurity; OFEV Impurity 93
EINECS	Contact for details

Quality Control

Our Nintedanib Impurity 93 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC purity analysis, spectroscopic identification (IR, NMR, MS), and determination of residual solvents to ensure compliance with pharmaceutical reference standard requirements. Comprehensive Certificates of Analysis (COA) with detailed chromatograms and spectral data are provided to support your regulatory and quality needs.

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. The product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability.

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)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 1.0% Total impurities ≤ 3.0%
Water Content (KF)	≤ 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.