Description

Nilotinib Genotoxic Impurity 2 CAS NO 1157857-29-8 is a high-purity reference standard used for the identification and quantification of a specific genotoxic impurity in the active pharmaceutical ingredient (API) Nilotinib. This compound is critical for ensuring the safety and regulatory compliance of pharmaceutical products by monitoring and controlling potentially harmful process-related substances. It is an essential analytical tool for quality control laboratories, research institutions, and pharmaceutical manufacturers involved in the development and production of Nilotinib and related tyrosine kinase inhibitors.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for analytical method development, validation, and routine quality control testing of Nilotinib API.
• Impurity Profiling and Control: Critical for establishing and monitoring the specification limits for this genotoxic impurity as per ICH Q3A(R2) and Q3B(R2) guidelines.
• Regulatory Submissions: Supports the preparation of Chemistry, Manufacturing, and Controls (CMC) documentation for regulatory filings with agencies like the FDA, EMA, and PMDA.
• Stability Studies: Used to track the formation and levels of this impurity in Nilotinib drug substance and drug product over time under various storage conditions.
• Process Chemistry Research: Aids in the optimization of synthetic routes and purification processes to minimize the formation of this impurity.
• Contract Research & Testing Labs: Serves as a critical reagent for third-party laboratories providing analytical and compliance testing services to the pharmaceutical industry.

Basic Information

Product Name	Nilotinib Genotoxic Impurity 2
CAS No.	1157857-29-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Nilotinib Impurity 2; Nilotinib Related Compound 2; Genotoxic Impurity 2 of Nilotinib; 4-Methyl-N-[3-(4-methyl-1H-imidazol-1-yl)-5-(trifluoromethyl)phenyl]-3-[[4-(3-pyridinyl)-2-pyrimidinyl]amino]benzamide (IUPAC); Nilotinib EP Impurity B; Nilotinib USP Impurity; AMN107 Impurity 2; Tasigna Impurity 2
EINECS	Contact for details

Quality Control

Every batch of Nilotinib Genotoxic Impurity 2 is manufactured and analyzed under strict quality management systems. The product undergoes comprehensive testing, including identity confirmation by spectroscopic methods (IR, NMR, MS), purity determination by HPLC, and specific tests for residual solvents and heavy metals. A comprehensive Certificate of Analysis (COA) is provided with each lot, detailing all analytical results against predefined specifications. Our quality commitment aligns with cGMP principles and supports compliance with major pharmacopoeial standards (USP, EP, JP).

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 (e.g., nitrogen atmosphere) after opening to prevent degradation. For long-term storage, consider storing at 2-8°C.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0% w/w

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