Description

Nilotinib Impurity 1 is a specified organic impurity associated with the active pharmaceutical ingredient 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. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies to ensure the purity, safety, and efficacy of Nilotinib drug substances and products.

Application

• Primary use as a certified reference standard (CRS) for the identification and quantification of impurities in Nilotinib API.
• Essential for analytical method development and validation (HPLC, UPLC, LC-MS) in pharmaceutical QC/QA laboratories.
• Used in stability studies and degradation pathway elucidation for Nilotinib formulations.
• Serves as a critical material for regulatory submissions (e.g., ANDA, NDA) to health authorities like the US FDA and EMA.
• Applied in pharmacopoeial testing to comply with monograph specifications from USP, EP, or other pharmacopoeias.
• Utilized in research and development for process chemistry optimization and impurity profiling.

Basic Information

Product Name	Nilotinib Impurity 1
CAS No.	641571-05-3
Molecular Formula	C28H22F3N7O
Molecular Weight	529.52 g/mol
Synonyms	Nilotinib Related Compound 1; Nilotinib Impurity A; 4-Methyl-N-[3-(4-methyl-1H-imidazol-1-yl)-5-(trifluoromethyl)phenyl]-3-[[4-(3-pyridinyl)-2-pyrimidinyl]amino]benzamide; UNII-8J8V7QJ4V5; 8J8V7QJ4V5; Nilotinib EP Impurity A; Nilotinib USP Impurity 1
EINECS	Contact for details

Quality Control

Every batch of Nilotinib Impurity 1 is manufactured and controlled under a strict quality management system. The material is characterized and qualified using advanced analytical techniques including HPLC, LC-MS, NMR, and IR spectroscopy to ensure identity, purity, and traceability. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. Our quality standards are designed to meet the rigorous requirements of pharmaceutical reference materials for regulatory compliance.

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 hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term storage, consider desiccant in the container. Keep away from incompatible materials.

Specification

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

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