Description

Afatinib Dimaleate is a high-purity, small-molecule active pharmaceutical ingredient (API) designed for advanced pharmaceutical research and development. This compound serves as a potent and irreversible inhibitor of the ErbB family of tyrosine kinases, making it a critical component in the development of targeted cancer therapies. It is primarily utilized by pharmaceutical manufacturers, contract research organizations (CROs), and academic research institutions engaged in oncology drug discovery and formulation.

Application

• Pharmaceutical API: Primary active ingredient in the manufacture of targeted anti-cancer medications.
• Oncology Research: Key reference standard and biochemical tool for studying EGFR (Epidermal Growth Factor Receptor) and HER2 signaling pathways in cancer cells.
• Preclinical Development: Used in pharmacokinetic, pharmacodynamic, and toxicology studies for new drug candidates.
• Formulation Development: Serves as the core component in developing solid dosage forms such as tablets and capsules.
• Analytical Standard: High-purity material used for method development, validation, and quality control testing in analytical laboratories.

Basic Information

Product Name	Afatinib Dimaleate
CAS No.	850140-73-7
Molecular Formula	C₂₄H₂₅ClFN₅O₃ • C₄H₄O₄
Molecular Weight	718.1 g/mol
Synonyms	Afatinib Dimaleate; BIBW 2992 MA2; Afatinib (Dimaleate); Gilotrif (Dimaleate Salt); Giotrif (Dimaleate); (2E)-N-[4-[(3-Chloro-4-fluorophenyl)amino]-7-[[(3S)-tetrahydro-3-furanyl]oxy]-6- quinazolinyl]-4-(dimethylamino)-2-butenamide (2Z)-2-butenedioate; BIBW2992 Dimaleate; Tovok (Dimaleate)
EINECS	Contact for details

Quality Control

Our Afatinib Dimaleate is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing to ensure it meets stringent specifications for identity, purity, and potency, suitable for pharmaceutical R&D applications. A detailed Certificate of Analysis (COA) is provided with each shipment, documenting results for assay, related substances, residual solvents, and other critical parameters.

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. 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)	98.0% - 102.0% (on anhydrous basis)
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single impurity ≤ 0.5%
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Heavy Metals	≤ 20 ppm

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