Description

Neratinib Impurity 2 CAS NO 1144516-13-1 is a high-purity chemical reference standard used for the analytical characterization and quality control of the active pharmaceutical ingredient Neratinib. This impurity is critical for pharmaceutical development and manufacturing, enabling precise monitoring and control to ensure drug safety and efficacy. It is primarily required by pharmaceutical companies, contract research organizations (CROs), and analytical laboratories involved in the development, validation, and regulatory submission of Neratinib-based drug products.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for method development, validation, and routine quality control testing of Neratinib API.
• Analytical Research: Used in HPLC, LC-MS, and other chromatographic analyses for the identification and quantification of related substances in drug substances and products.
• Regulatory Compliance: Essential for preparing documentation for regulatory submissions (e.g., to FDA, EMA) to demonstrate comprehensive impurity profiling.
• Stability Studies: Employed as a marker to track impurity formation and degradation pathways during forced degradation and long-term stability studies of Neratinib formulations.
• Process Chemistry: Aids in the optimization of synthesis and purification processes by identifying and quantifying this specific process-related impurity.
• Pharmacopoeial Testing: Supports testing to meet the specifications outlined in relevant pharmacopoeial monographs for Neratinib.

Basic Information

Product Name	Neratinib Impurity 2
CAS No.	1144516-13-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Neratinib Related Compound 2; Neratinib Impurity B; HKI-272 Impurity 2; (E)-N-[4-[[3-Chloro-4-[(pyridin-2-yl)methoxy]phenyl]amino]-3-cyano-7-ethoxyquinolin-6-yl]-4-(dimethylamino)but-2-enamide; 6-Quinolinecarboxamide, N-[4-[[3-chloro-4-[(2-pyridinylmethyl)oxy]phenyl]amino]-3-cyano-7-ethoxy-6-quinolinyl]-4-(dimethylamino)-2-butenamide, (2E)-; Neratinib EP Impurity B; Neratinib USP Impurity 2
EINECS	Contact for details

Quality Control

Our Neratinib Impurity 2 is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing, including chromatographic purity (HPLC), identity confirmation (IR, MS), and residual solvent analysis, to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing all test results and specifications.

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 is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability.

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)	Single unspecified impurity ≤ 1.0% Total impurities ≤ 2.0%
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with ICH guidelines

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