Description

Nilotinib Genotoxic Impurity 3 is a high-purity reference standard critical for pharmaceutical quality control and regulatory compliance. This compound is specifically used for the identification, quantification, and control of a key genotoxic impurity during the manufacturing and quality assurance of the active pharmaceutical ingredient (API) Nilotinib. It is an essential material for analytical method development, validation, and routine testing in pharmaceutical R&D and quality control laboratories. Ensuring the accurate monitoring of this impurity is paramount for patient safety and meeting stringent global regulatory standards for oncology drugs.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the qualitative and quantitative analysis of Nilotinib impurities.
• Analytical Method Development & Validation: Critical for developing and validating sensitive HPLC, UPLC, or LC-MS/MS methods to detect and quantify genotoxic impurities (GTIs) at trace levels.
• Quality Control & Batch Release: Used in QC laboratories to test Nilotinib API and finished drug products against ICH Q3A/B guidelines for impurity profiles.
• Regulatory Submissions: Supports the preparation of regulatory filings (e.g., for FDA, EMA) by providing definitive impurity characterization and control strategy data.
• Stability Studies: Employed to monitor impurity levels in Nilotinib formulations under various stability-indicating conditions.
• Pharmacopeial Testing: Potential use as a system suitability standard in pharmacopeial monographs for Nilotinib.

Basic Information

Product Name	Nilotinib Genotoxic Impurity 3
CAS No.	915711-42-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Nilotinib Impurity 3; Nilotinib Related Compound 3; 4-Methyl-N-[3-(4-methyl-1H-imidazol-1-yl)-5-(trifluoromethyl)phenyl]-3-[[4-(3-pyridinyl)-2-pyrimidinyl]amino]benzamide; Nilotinib EP Impurity C; Nilotinib USP Impurity C; Tasigna Impurity 3; UNII-9K5J6W3F8I
EINECS	Contact for details

Quality Control

Every batch of Nilotinib Genotoxic Impurity 3 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity assay, and impurity profiling using advanced chromatographic and spectroscopic techniques (e.g., HPLC, GC, NMR, MS) to ensure compliance with pharmaceutical reference standard requirements. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment, supporting traceability and regulatory needs.

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. The material should be kept in a dry environment and handled under appropriate laboratory conditions to preserve stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (IR)	Spectrum conforms to reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%

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