Description

Lapatinib is a small molecule, dual tyrosine kinase inhibitor that targets the epidermal growth factor receptor (EGFR) and human epidermal growth factor receptor 2 (HER2). This compound is of significant commercial and therapeutic importance as a key active pharmaceutical ingredient (API) in targeted cancer therapies. It is primarily required by pharmaceutical manufacturers and research institutions engaged in the development and production of oncology drugs, particularly for the treatment of advanced or metastatic breast cancer.

Application

• Pharmaceutical API: Primary use as the active ingredient in formulated anti-cancer medications, specifically in combination therapy for HER2-positive metastatic breast cancer.
• Biomedical Research: Critical tool compound for in vitro and in vivo studies investigating EGFR/HER2 signaling pathways, drug resistance mechanisms, and combination treatment strategies.
• Reference Standard: Serves as a high-purity analytical standard for quality control testing in pharmaceutical manufacturing and regulatory submissions.
• Preclinical Development: Used in pharmacokinetic, pharmacodynamic, and toxicology studies to support Investigational New Drug (IND) applications.
• Formulation Development: Employed in the R&D of novel drug delivery systems, such as nanoparticles or liposomes, to improve bioavailability and efficacy.

Basic Information

Product Name	Lapatinib
CAS No.	231277-92-2
Molecular Formula	C₂₉H₂₆ClFN₄O₄S
Molecular Weight	581.06 g/mol
Synonyms	Lapatinib Ditosylate Monohydrate (Salt Form); GW572016; Tykerb (Trade Name); Tyverb (Trade Name); N-[3-Chloro-4-[(3-fluorophenyl)methoxy]phenyl]-6-[5-[[[2-(methylsulfonyl)ethyl]amino]methyl]-2-furanyl]-4-quinazolinamine; GW2016
EINECS	Contact for details

Quality Control

Our Lapatinib is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing to ensure it meets the stringent specifications required for pharmaceutical use, including identity, purity, and impurity profile. We provide full traceability and support regulatory filings. Certificates of Analysis (COA) confirming 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 (15-25°C). This product is hygroscopic (moisture-sensitive) and must be kept under dry conditions to prevent degradation. For long-term storage, consider desiccants or inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 98.5%
Related Substances (HPLC)	Total impurities ≤ 1.5% Any single unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Heavy Metals	≤ 20 ppm
Loss on Drying	≤ 0.5%
Residue on Ignition	≤ 0.1%

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