Description

Neratinib Impurity 3 is a designated impurity of the tyrosine kinase inhibitor Neratinib, used in pharmaceutical research and development. This compound is critical for analytical method development, stability studies, and ensuring the quality and safety of the active pharmaceutical ingredient (API). It is primarily required by pharmaceutical manufacturers, contract research organizations (CROs), and analytical laboratories involved in the synthesis, purification, and regulatory compliance of Neratinib.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Neratinib Impurity 3 in drug substances and products.
• Analytical Method Development and Validation: Essential for developing and validating HPLC, UPLC, or LC-MS methods to monitor impurity profiles.
• Stability Studies and Forced Degradation: Employed to understand degradation pathways and establish shelf-life specifications for Neratinib formulations.
• Quality Control and Batch Release: Serves as a critical benchmark in QC laboratories to ensure API batches meet stringent pharmacopeial (e.g., USP, ICH) impurity limits.
• Regulatory Submissions: Provides necessary data for Drug Master Files (DMFs), Investigational New Drug (IND), and New Drug Application (NDA) filings to health authorities like the FDA and EMA.
• Process Chemistry Research: Used by chemists to study and optimize synthesis routes to minimize the formation of this specific impurity.

Basic Information

Product Name	Neratinib Impurity 3
CAS No.	1144516-16-4
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Neratinib Related Compound 3; Neratinib EP Impurity C; Neratinib USP Impurity; HKI-272 Impurity 3; (2E)-N-[4-[[3-Chloro-4-[(pyridin-2-yl)methoxy]phenyl]amino]-3-cyano-7-ethoxyquinolin-6-yl]-4-(dimethylamino)but-2-enamide; PF-05208770 Impurity; 6-Quinolinecarboxamide, N-[4-[[3-chloro-4-[(2-pyridinylmethyl)oxy]phenyl]amino]-3-cyano-7-ethoxy-6-quinolinyl]-4-(dimethylamino)-2-butenamide
EINECS	Contact for details

Quality Control

Our Neratinib Impurity 3 is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing, including HPLC purity, identity confirmation (IR, MS), and residual solvent analysis, to ensure compliance with ICH Q3A/B guidelines and internal specifications. A comprehensive Certificate of Analysis (COA) detailing all test results is provided with every shipment.

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 product is hygroscopic (moisture-sensitive) and should be handled under dry conditions to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual 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.