Description

Pyrotinib Maleate CAS NO 1397922-61-0 is a small molecule, irreversible tyrosine kinase inhibitor specifically targeting the human epidermal growth factor receptor 2 (HER2) and epidermal growth factor receptor (EGFR). This compound is of critical importance in the development of targeted cancer therapies, particularly for HER2-positive breast cancer. It is primarily needed by pharmaceutical R&D departments, contract research organizations (CROs), and manufacturers of active pharmaceutical ingredients (APIs) engaged in oncology drug development and production.

Application

• Active Pharmaceutical Ingredient (API): Core component in the formulation of anti-cancer drugs targeting HER2-positive malignancies.
• Oncology Research & Development: Critical reference standard and investigational compound for studying HER2/EGFR signaling pathways and resistance mechanisms.
• Preclinical and Clinical Studies: Used in pharmacological, pharmacokinetic, and toxicological evaluations during drug development stages.
• Pharmaceutical Intermediates: Serves as a key intermediate for the synthesis of more complex drug formulations or prodrugs.
• Biochemical Assay Development: Utilized as a standard inhibitor in high-throughput screening (HTS) and enzyme activity assays.
• Academic Research: Employed in university and institutional labs for basic cancer biology and targeted therapy research.

Basic Information

Product Name	Pyrotinib Maleate
CAS No.	1397922-61-0
Molecular Formula	C₃₂H₃₃ClFN₅O₅ • C₄H₄O₄
Molecular Weight	710.15 g/mol
Synonyms	Pyrotinib maleate salt; (E)-N-[4-[[3-Chloro-4-[(pyridin-2-yl)methoxy]phenyl]amino]-3-cyano-7-ethoxyquinolin-6-yl]-4-(dimethylamino)but-2-enamide maleate; SHR-1258 maleate; Irrotinib maleate; AiRuiYi; Icotinib Hydrochloride Analog; HER2/EGFR Dual Inhibitor; (E)-N-(4-((3-chloro-4-((pyridin-2-ylmethyl)oxy)phenyl)amino)-3-cyano-7-ethoxyquinolin-6-yl)-4-(dimethylamino)but-2-enamide (Z)-butenedioate
EINECS	Contact for details

Quality Control

Our Pyrotinib Maleate is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing to ensure identity, purity, and consistency, meeting high standards for pharmaceutical research and development. Certificates of Analysis (COA) detailing specifications such as assay, related substances, residual solvents, and heavy metals are provided with every shipment. We support compliance with ICH guidelines and can supply material suitable for use under cGMP conditions for advanced clinical trials.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F). This product is hygroscopic (moisture-sensitive) and must 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 powder
Identification (IR)	Conforms to structure
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%
Residual Solvents (GC)	Complies with ICH Q3C
Heavy Metals	≤20 ppm
Specific Rotation	Contact for details

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