Description

Nilotinib Impurity 28 is a designated impurity reference standard used in the pharmaceutical development and quality control of the active pharmaceutical ingredient (API) Nilotinib. This high-purity compound is critical for ensuring the safety, efficacy, and regulatory compliance of the final drug product by enabling accurate identification and quantification of related substances. It is an essential material for analytical laboratories, quality assurance departments, and research institutions within the global pharmaceutical and contract research organization (CRO) sectors.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Nilotinib Impurity 28 in drug substance and drug product batches.
• Analytical Method Development & Validation: Critical for developing, validating, and transferring HPLC, UPLC, or LC-MS methods for impurity profiling of Nilotinib.
• Quality Control & Assurance (QC/QA): Used in routine quality control testing to monitor impurity levels against International Council for Harmonisation (ICH) guidelines and established specifications.
• Stability Studies: Employed to track the formation and growth of this specific impurity during forced degradation and long-term stability studies of Nilotinib formulations.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., with FDA, EMA) to demonstrate comprehensive impurity characterization and control strategies.
• Research & Development: Supports process chemistry research to understand impurity formation pathways and optimize synthesis and purification processes for Nilotinib.

Basic Information

Product Name	Nilotinib Impurity 28
CAS No.	1807607-72-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Nilotinib Related Compound 28; Nilotinib EP Impurity I; Nilotinib USP Impurity; 4-Methyl-N-[3-(4-methyl-1H-imidazol-1-yl)-5-(trifluoromethyl)phenyl]-3-[(4-pyridin-3-ylpyrimidin-2-yl)amino]benzamide Impurity; UNII-9F8W1J6R2K; Nilotinib Impurity I (EP); Nilotinib Process Impurity
EINECS	Contact for details

Quality Control

Every batch of Nilotinib Impurity 28 is manufactured and handled under strict quality management systems. Our products undergo rigorous identity confirmation, purity analysis, and impurity profiling using advanced analytical techniques such as HPLC, LC-MS, NMR, and IR spectroscopy to ensure they meet the exacting standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results and confirming compliance with relevant standards.

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 material is hygroscopic (moisture-sensitive) and must be kept under inert conditions or in a desiccator to maintain stability and purity. Handle and store in accordance with good laboratory practices.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (IR)	Conforms to reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unknown impurity ≤ 1.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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