Description

Nilotinib Impurity 27 is a designated impurity associated with the active pharmaceutical ingredient Nilotinib, a tyrosine kinase inhibitor. This compound is critical for pharmaceutical research and development, specifically for analytical method development, stability studies, and ensuring the quality and safety of the final drug product. It is primarily used by pharmaceutical manufacturers, contract research organizations (CROs), and analytical laboratories engaged in the synthesis, purification, and regulatory compliance of Nilotinib.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Nilotinib drug substance and drug products.
• Analytical Method Development and Validation: Essential for developing and validating chromatographic methods (e.g., HPLC, UPLC) to monitor impurity profiles.
• Stability Studies: Employed to track the formation and levels of this specific impurity under various stress conditions to establish drug shelf-life.
• Quality Control & Assurance: Serves as a critical tool for in-process testing and final release testing to ensure compliance with ICH guidelines and pharmacopeial standards.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., FDA, EMA) to demonstrate thorough impurity characterization and control.
• Research on Degradation Pathways: Used in forced degradation studies to understand the chemical behavior and degradation mechanisms of Nilotinib.

Basic Information

Item	Details
Product Name	Nilotinib Impurity 27
CAS No.	1807606-80-9
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Nilotinib Related Compound 27; Nilotinib EP Impurity G; Nilotinib Impurity G; 4-Methyl-N-[3-(4-methyl-1H-imidazol-1-yl)-5-(trifluoromethyl)phenyl]-3-[[4-(3-pyridinyl)-2-pyrimidinyl]amino]benzamide; UNII-8V8T6W8Q6R; 8V8T6W8Q6R; Nilotinib Impurity 27 (EP)
EINECS	Contact for details

Quality Control

Our Nilotinib Impurity 27 is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing to ensure identity, purity, and consistency, aligning with ICH Q3A/B guidelines and relevant pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for assay, impurities, and other critical parameters.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time corresponds to reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unknown impurity ≤ 1.0% Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0% w/w

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