Description

Pyrotinib Maleate CAS NO 704881-43-6 is a small molecule tyrosine kinase inhibitor specifically targeting the human epidermal growth factor receptor 2 (HER2). This compound is a critical active pharmaceutical ingredient (API) used in the development and manufacturing of targeted cancer therapies. It is primarily required by pharmaceutical companies and research institutions engaged in oncology drug development, particularly for the treatment of HER2-positive breast cancer.

Application

• Pharmaceutical API: Primary use as the active ingredient in the formulation of anti-cancer drugs targeting HER2-positive malignancies.
• Oncology Research: A key reference standard and investigational compound in preclinical and clinical studies for novel HER2-targeted therapies.
• Drug Development: Utilized in pharmacokinetic, pharmacodynamic, and toxicology studies during the drug discovery pipeline.
• Biochemical Research: Serves as a potent and selective tool for studying HER2 signaling pathways and mechanisms of tyrosine kinase inhibition in cellular models.
• Formulation Development: Used in the development of various dosage forms, including tablets and capsules, for clinical trials and commercial production.
• Quality Control & Analytical Standards: Acts as a high-purity reference standard for HPLC, LC-MS, and other analytical methods to ensure drug product quality.

Basic Information

Product Name	Pyrotinib Maleate
CAS No.	704881-43-6
Molecular Formula	C₃₂H₃₃ClFN₅O₅ • C₄H₄O₄
Molecular Weight	710.15 g/mol
Synonyms	Pyrotinib Maleate; (E)-N-[4-[[3-Chloro-4-(2-pyridinylmethoxy)phenyl]amino]-3-cyano-7-ethoxy-6-quinolinyl]-4-(dimethylamino)-2-butenamide maleate; Irinitib Maleate; SHR-1258 Maleate; AiRuiYi (艾瑞颐); HER2/EGFR Dual Inhibitor Pyrotinib Maleate
EINECS	Contact for details

Quality Control

Our Pyrotinib Maleate is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing to ensure identity, purity, and potency meet stringent specifications for pharmaceutical use. We provide full traceability and support regulatory filings. Certificates of Analysis (COA) documenting compliance with in-house specifications are available upon request.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (typically 15-25°C). This product is hygroscopic (moisture-sensitive) and must be kept under dry conditions to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	≥ 98.5%
Related Substances (HPLC)	Total impurities ≤ 1.5% Any single unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0%
Heavy Metals	≤ 20 ppm
Residue on Ignition	≤ 0.2%

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