Description

Afatinib is a potent, irreversible inhibitor of the ErbB family of tyrosine kinases, representing a critical class of targeted therapeutic agents. Its primary value lies in its specific mechanism of action, which disrupts key signaling pathways involved in uncontrolled cell proliferation. This makes it an essential active pharmaceutical ingredient (API) for the research and development of advanced oncology treatments. Pharmaceutical manufacturers and advanced research institutions globally rely on high-purity Afatinib for formulating next-generation cancer therapies.

Application

• Pharmaceutical API: Primary use as the active ingredient in the manufacture of targeted anti-cancer drugs.
• Oncology Research: Critical reagent in preclinical and clinical studies focusing on EGFR (Epidermal Growth Factor Receptor) and HER2 (Human Epidermal Growth Factor Receptor 2) driven cancers.
• Biochemical Assay Development: Used as a standard or inhibitor in developing high-throughput screening assays for kinase activity.
• Mechanistic Studies: Employed in academic and industrial research to investigate resistance mechanisms and combination therapy strategies in oncology.
• Reference Standard: Serves as a high-purity analytical standard for quality control and pharmacokinetic studies in pharmaceutical development.

Basic Information

Product Name	Afatinib
CAS No.	850140-72-6
Molecular Formula	C24H25ClFN5O3
Molecular Weight	485.94 g/mol
Synonyms	BIBW 2992; Afatinib dimaleate (salt form); (2E)-N-[4-(3-Chloro-4-fluorophenyl)amino]-7-[[(3S)-oxolan-3-yl]oxy]quinazolin-6-yl]-4-(dimethylamino)but-2-enamide; Tovok; Gilotrif; Giotrif; Tomtovok
EINECS	Contact for details

Quality Control

Our Afatinib is manufactured and tested under strict quality management systems to ensure it meets the rigorous standards required for pharmaceutical applications. Each batch undergoes comprehensive analytical testing, including identification, purity assay, and impurity profiling via advanced techniques like HPLC and LC-MS. A Certificate of Analysis (COA) detailing all specifications and results is provided with every shipment to guarantee traceability and compliance.

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 in a dry environment to maintain stability and potency. For long-term storage, consider desiccated conditions.

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
Loss on Drying	≤ 0.5%
Heavy Metals	≤ 20 ppm

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