Description

Neratinib Maleate CAS NO 915942-22-2 is a potent, irreversible tyrosine kinase inhibitor specifically targeting the human epidermal growth factor receptor (HER) family. This high-purity active pharmaceutical ingredient (API) is critical for the development and manufacturing of targeted cancer therapies. It is primarily required by pharmaceutical companies and research institutions engaged in oncology drug development, clinical trials, and the production of finished dosage forms for the treatment of HER2-positive breast cancer and other solid tumors.

Application

• Pharmaceutical API: Primary active ingredient in the formulation of oral anti-cancer medications.
• Oncology Research: Critical reference standard and biochemical tool for studying HER2/EGFR signaling pathways and mechanisms of drug resistance.
• Clinical Trial Material (CTM): Manufactured under GMP conditions for use in Phase I-III clinical studies.
• Drug Product Manufacturing: Used in the commercial-scale production of finished tablet formulations.
• Preclinical Development: Employed in pharmacokinetic, pharmacodynamic, and toxicology studies.
• Combinational Therapy Research: Investigated in conjunction with other chemotherapeutic agents for enhanced efficacy.

Basic Information

Product Name	Neratinib Maleate
CAS No.	915942-22-2
Molecular Formula	C₃₀H₂₉ClN₆O₃ • C₄H₄O₄
Molecular Weight	673.09 g/mol (as maleate salt)
Synonyms	Neratinib Maleate Salt; HKI-272 Maleate; PB-272; (2E)-N-[4-[[3-Chloro-4-[(pyridin-2-yl)methoxy]phenyl]amino]-3-cyano-7-ethoxyquinolin-6-yl]-4-(dimethylamino)but-2-enamide maleate; Nerlynx (Brand Name); Irreversible pan-HER Tyrosine Kinase Inhibitor Maleate
EINECS	Contact for details

Quality Control

Our Neratinib Maleate is manufactured in facilities operating under current Good Manufacturing Practices (cGMP) and is supported by a comprehensive quality management system. Each batch undergoes rigorous analytical testing to ensure identity, purity, potency, and safety, meeting stringent pharmacopeial standards. A detailed Certificate of Analysis (COA) is provided with every shipment, documenting specifications for assay, related substances, residual solvents, heavy metals, and microbiological quality.

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 dry, inert conditions to maintain stability and prevent degradation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference standard
Identification (HPLC)	Retention time matches reference
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	≤ 1.0%
Related Substances (HPLC)	Total impurities ≤ 2.0%; Any single unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Heavy Metals	≤ 20 ppm
Microbiological Enumeration	Meets Ph. Eur. 2.6.12/2.6.13 criteria

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