Description

Nilotinib Impurity 17 is a designated impurity of the active pharmaceutical ingredient (API) Nilotinib, a tyrosine kinase inhibitor used in cancer therapy. This compound is critical for pharmaceutical research and development, serving as a reference standard for analytical method development, quality control, and regulatory compliance. It is essential for analytical chemists, quality assurance professionals, and researchers in the pharmaceutical industry who are involved in the synthesis, purification, and quality monitoring of Nilotinib drug substances and products.

Application

• Primary use as a certified reference standard for the identification and quantification of impurities in Nilotinib API and finished drug products.
• Critical component in analytical method development and validation (e.g., HPLC, UPLC, LC-MS) for impurity profiling.
• Essential for pharmaceutical quality control (QC) and stability studies to ensure batch-to-batch consistency and compliance with ICH guidelines.
• Used in regulatory submissions (e.g., for FDA, EMA) to establish impurity thresholds and justify specifications.
• Valuable for research and development into the degradation pathways and metabolism of Nilotinib.
• Supports pharmacopoeial testing and helps manufacturers meet stringent pharmacopoeial standards (e.g., USP, EP).

Basic Information

Product Name	Nilotinib Impurity 17
CAS No.	851137-91-2
Molecular Formula	C28H22F3N7O
Molecular Weight	529.52 g/mol
Synonyms	Nilotinib Related Compound 17; Nilotinib Impurity B; 4-Methyl-N-[3-(4-methyl-1H-imidazol-1-yl)-5-(trifluoromethyl)phenyl]-3-[[4-(3-pyridinyl)-2-pyrimidinyl]amino]benzamide; UNII-9W4H8E8U4N; 9W4H8E8U4N; Benzamide, 4-methyl-N-[3-(4-methyl-1H-imidazol-1-yl)-5-(trifluoromethyl)phenyl]-3-[[4-(3-pyridinyl)-2-pyrimidinyl]amino]-
EINECS	Contact for details

Quality Control

Our Nilotinib Impurity 17 is manufactured under strict quality systems to ensure the highest standards of purity and traceability, suitable for use in regulated environments. Each batch is accompanied by a comprehensive Certificate of Analysis (COA) detailing identity, purity, and impurity profiles as determined by advanced chromatographic and spectroscopic techniques (HPLC, LC-MS, NMR). We support compliance with ICH Q3A/B, USP, and EP guidelines for pharmaceutical impurities.

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 product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any single unknown impurity ≤ 1.0%
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.