Description

Neratinib Impurity 4 CAS NO 1144516-18-6 is a high-purity reference standard used in the pharmaceutical development and quality control of Neratinib, a targeted cancer therapy. This compound is critical for ensuring the safety, efficacy, and regulatory compliance of the active pharmaceutical ingredient by enabling accurate identification and quantification of related substances. It is an essential material for analytical chemists and quality assurance professionals in pharmaceutical R&D and manufacturing.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Neratinib-related impurities in drug substance and drug product.
• Analytical Method Development & Validation: Used to develop, optimize, and validate stability-indicating HPLC/UPLC methods for impurity profiling.
• Quality Control & Batch Release Testing: Employed in routine QC laboratories to monitor impurity levels against ICH Q3A/B guidelines, ensuring batch-to-batch consistency.
• Stability Studies: A key component in forced degradation and long-term stability studies to track impurity formation pathways and kinetics.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., FDA, EMA) to establish impurity acceptance criteria and control strategies.
• Process Chemistry Research: Aids in understanding and optimizing the synthetic pathway of Neratinib to minimize the formation of this specific impurity.

Basic Information

Product Name	Neratinib Impurity 4
CAS No.	1144516-18-6
Molecular Formula	C30H29ClN6O3
Molecular Weight	557.04 g/mol
Synonyms	Neratinib Related Compound 4; Neratinib EP Impurity D; Neratinib USP Impurity D; (2E)-N-[4-[[3-Chloro-4-[(pyridin-2-yl)methoxy]phenyl]amino]-3-cyano-7-ethoxyquinolin-6-yl]-4-(dimethylamino)but-2-enamide; HKI-272 Impurity 4; PB-272 Impurity 4; UNII-7Q7F2JQ2QH
EINECS	Contact for details

Quality Control

Our Neratinib Impurity 4 is manufactured under strict quality management systems. Each batch is subjected to comprehensive analytical testing, including HPLC purity determination, residual solvent analysis (GC), and structural confirmation (NMR, MS) to ensure identity and purity meet the highest standards for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) with batch-specific data is provided with every shipment.

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. Due to its hygroscopic nature, the container should be kept in a dry environment. For long-term storage, consider desiccants or inert atmosphere to maintain stability.

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)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0%
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.