Description

Neratinib-003 CAS NO 871895-08-8 is a high-purity pharmaceutical intermediate and reference standard, specifically designed for research and development in the field of oncology. This compound is critical for the synthesis and analytical validation of Neratinib, a potent and irreversible tyrosine kinase inhibitor targeting HER2 and EGFR. It serves as an essential building block for pharmaceutical manufacturers, contract research organizations (CROs), and academic institutions engaged in the development of novel cancer therapeutics and bioanalytical methods.

Application

• Pharmaceutical Intermediate: A key precursor in the multi-step synthesis of the active pharmaceutical ingredient (API) Neratinib.
• Reference Standard: Used for method development, validation, and quality control (HPLC, LC-MS) in analytical laboratories.
• Process Research & Development (R&D): Employed in route scouting, optimization, and scale-up studies for API manufacturing.
• Impurity Profiling: Serves as a characterized impurity or degradation product standard to ensure API purity and stability.
• Metabolite Studies: Utilized in the identification and synthesis of potential metabolites for pharmacokinetic and toxicological research.
• Custom Synthesis: Acts as a starting material for the creation of novel analogs and derivatives for structure-activity relationship (SAR) studies.

Basic Information

Product Name	Neratinib-003
CAS No.	871895-08-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Neratinib Intermediate; Neratinib Impurity; HKI-272 Intermediate; (2E)-N-[4-[[3-Chloro-4-[(pyridin-2-yl)methoxy]phenyl]amino]-3-cyano-7-ethoxyquinolin-6-yl]-4-(dimethylamino)but-2-enamide derivative; 6-Quinolinecarboxamide, N-[4-[[3-chloro-4-[(2-pyridinylmethyl)oxy]phenyl]amino]-3-cyano-7-ethoxy-6-quinolinyl]-4-(dimethylamino)-2-butenamide related compound; UNII-0S8BXW4R1I (component); Neratinib Related Compound
EINECS	Contact for details

Quality Control

Our Neratinib-003 is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity, NMR and MS for structural confirmation, and residual solvent analysis. We provide a comprehensive Certificate of Analysis (COA) with each shipment, detailing all test results against established in-house specifications. Our quality commitment ensures material consistency and traceability, supporting your regulatory filings and GMP compliance needs.

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 atmosphere (e.g., nitrogen or argon) after opening to prevent degradation. Keep the container tightly sealed in a desiccator for long-term storage.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (MS)	Conforms
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual impurity ≤ 0.5% Total impurities ≤ 2.0%
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Meets ICH Q3C guidelines

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