Description

Nilotinib Impurity 4 is a specified organic impurity associated with the active pharmaceutical ingredient (API) Nilotinib, 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 processes. It is primarily utilized by analytical chemists, quality assurance professionals, and researchers in the pharmaceutical and biotechnology industries to ensure the purity, safety, and efficacy of Nilotinib drug substances and products.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Nilotinib API and finished drug products.
• Analytical Method Development: Essential for developing and optimizing chromatographic methods, such as HPLC and UPLC, for impurity profiling.
• Quality Control & Assurance: Employed in routine batch testing to monitor impurity levels and ensure compliance with ICH Q3A/B guidelines and regulatory specifications.
• Stability Studies: Used to track the formation of degradation products under various stress conditions (e.g., heat, light, humidity) as per ICH stability guidelines.
• Regulatory Submissions: Provides necessary data on impurity identity and levels for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Process Chemistry Research: Aids in understanding and controlling impurity formation during the synthesis and purification stages of Nilotinib manufacturing.

Basic Information

Product Name	Nilotinib Impurity 4
CAS No.	2119583-27-4
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Nilotinib Related Compound 4; Nilotinib EP Impurity D; Nilotinib USP Impurity D; Nilotinib Process Impurity; 4-Methyl-N-[3-(4-methyl-1H-imidazol-1-yl)-5-(trifluoromethyl)phenyl]-3-[[4-(3-pyridinyl)-2-pyrimidinyl]amino]benzamide Impurity; AMN107 Impurity 4
EINECS	Contact for details

Quality Control

Our Nilotinib Impurity 4 is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure identity, purity, and consistency. Each batch is supplied with a comprehensive Certificate of Analysis (COA) detailing results from multiple orthogonal techniques, including HPLC, NMR, and MS. Our quality standards align with current guidelines for pharmaceutical impurities, including ICH Q3A(R2) and Q3B(R2).

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 nature, the container should be kept in a desiccated environment to prevent moisture uptake. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Any individual impurity ≤ 2.0%
Total Impurities	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0%

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