Description

Neratinib CAS NO 698387-09-6 is a potent, irreversible small-molecule tyrosine kinase inhibitor targeting the human epidermal growth factor receptor (HER) family. This compound is of significant commercial and therapeutic interest for its targeted mechanism of action in oncology research and development. It is primarily required by pharmaceutical R&D laboratories, contract research organizations (CROs), and manufacturers of active pharmaceutical ingredients (APIs) for the development of novel cancer therapeutics.

Application

• Pharmaceutical Intermediate: Critical raw material in the synthesis of finished dosage forms containing Neratinib as the active ingredient.
• Oncology Research: Used as a reference standard and biochemical tool in preclinical studies to investigate HER2 and EGFR signaling pathways.
• API Manufacturing: Serves as the core chemical entity for the production of Neratinib active pharmaceutical ingredient under current Good Manufacturing Practices (cGMP).
• Clinical Trial Material: Supplied for the formulation of drugs used in Phase I-III clinical trials for breast cancer and other solid tumors.
• Mechanistic Studies: Employed in academic and industrial laboratories to study resistance mechanisms and combination therapies.
• Bioanalytical Standard: Used for method development, validation, and quality control in pharmacokinetic and pharmacodynamic assays.

Basic Information

Product Name	Neratinib
CAS No.	698387-09-6
Molecular Formula	C30H29ClN6O3
Molecular Weight	557.04 g/mol
Synonyms	HKI-272; PB-272; Nerlynx; (2E)-N-[4-[[3-Chloro-4-[(pyridin-2-yl)methoxy]phenyl]amino]-3-cyano-7-ethoxyquinolin-6-yl]-4-(dimethylamino)but-2-enamide; UNII-0J5NE5ZKF7
EINECS	Contact for details

Quality Control

Our Neratinib is manufactured and tested to meet stringent quality standards suitable for pharmaceutical development. Each batch undergoes comprehensive analytical testing including HPLC for purity and assay, residual solvent analysis, and identification by spectroscopic methods. A Certificate of Analysis (COA) is provided with each shipment, detailing all test results against predefined specifications. We support development with GMP-grade material and can supply DMF/CEP documentation as required for regulatory submissions.

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 must be kept under inert atmosphere or in a desiccator to maintain stability and potency. Keep container tightly sealed when not in use.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥98.0%
Related Substances (HPLC)	Total impurities ≤2.0% Any single unknown impurity ≤0.5%
Water Content (KF)	≤1.0%
Residue on Ignition	≤0.1%
Heavy Metals	≤20 ppm

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