Description

Nilotinib Impurity 11 is a designated impurity associated with the active pharmaceutical ingredient Nilotinib, a tyrosine kinase inhibitor. This compound is critical for pharmaceutical research and development, serving as a key reference standard for analytical method development, quality control, and regulatory compliance. It is primarily needed by pharmaceutical manufacturers, analytical laboratories, and research institutions involved in the synthesis, purification, and quality assurance of Nilotinib drug substances and products.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Nilotinib drug substance and finished dosage forms.
• Analytical Method Development and Validation: Essential for developing, optimizing, and validating chromatographic methods (e.g., HPLC, UPLC) to monitor impurity profiles.
• Quality Control & Assurance (QC/QA): A critical component in routine batch release testing to ensure Nilotinib meets stringent pharmacopeial (e.g., USP, EP) and ICH guidelines for impurity limits.
• Stability Studies: Employed to track the formation and level of this specific impurity during forced degradation and long-term stability studies of Nilotinib formulations.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., ANDA, NDA) to demonstrate comprehensive understanding and control of the drug's impurity profile.
• Process Chemistry Research: Used by chemists to study and optimize synthesis pathways to minimize the formation of this impurity during Nilotinib manufacturing.

Basic Information

Product Name	Nilotinib Impurity 11
CAS No.	2119583-24-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Nilotinib Related Compound 11; Nilotinib Impurity; Nilotinib EP Impurity I; Nilotinib USP Impurity; 4-Methyl-N-[3-(4-methyl-1H-imidazol-1-yl)-5-(trifluoromethyl)phenyl]-3-[[4-(3-pyridinyl)-2-pyrimidinyl]amino]benzamide Impurity; AMN107 Impurity 11; Tasigna Impurity 11
EINECS	Contact for details

Quality Control

Our Nilotinib Impurity 11 is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing, including HPLC for purity confirmation and identity verification by spectroscopic methods (IR, NMR, MS). We provide comprehensive Certificates of Analysis (COA) detailing batch-specific results, ensuring traceability and compliance with current Good Manufacturing Practice (cGMP) principles and ICH Q3A/B 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. The material should be kept in a dry environment to prevent moisture uptake. For long-term storage, consider storing under inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 1.0% 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.