Description

Afatinib (Bibw 2992) is a potent, irreversible inhibitor of the ErbB family of tyrosine kinases, specifically targeting EGFR (ErbB1), HER2 (ErbB2), and ErbB4. This mechanism of action makes it a critical active pharmaceutical ingredient (API) for the development of targeted cancer therapies. It is primarily required by pharmaceutical manufacturers and research institutions engaged in oncology drug development and clinical studies.

Application

• Primary Active Pharmaceutical Ingredient (API) in the formulation of targeted anti-cancer medications.
• Key reference standard for analytical method development and validation in quality control laboratories.
• Critical research compound for preclinical studies investigating mechanisms of tyrosine kinase inhibition.
• Essential material for clinical trials focused on non-small cell lung cancer (NSCLC) and other solid tumors.
• Building block for medicinal chemistry research and the synthesis of novel kinase inhibitor derivatives.
• Used in biochemical assays to study EGFR and HER2 signaling pathways and resistance mechanisms.

Basic Information

Product Name	Afatinib (Bibw 2992)
CAS No.	439081-18-2
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)-tetrahydro-3-furanyl]oxy]-6-quinazolinyl]-4-(dimethylamino)-2-butenamide; 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 high standards required for pharmaceutical research and development. Each batch is accompanied by a comprehensive Certificate of Analysis (COA) detailing purity, identity, and impurity profiles. We support compliance with cGMP (current Good Manufacturing Practice) guidelines and relevant pharmacopeial standards for active pharmaceutical ingredients.

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 anhydrous conditions. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference standard
Identification (HPLC)	Retention time corresponds to reference
Assay (HPLC)	≥ 98.5%
Related Substances (HPLC)	Total impurities ≤ 1.5% Any single 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.