Afatinib Raw Powder API

Advanced Tyrosine Kinase Inhibitor | High-Purity Pharmaceutical Grade

High Purity ≥98%

HPLC Tested

ErbB Family Inhibitor

CAS 439081-18-2

Storage Guidance:
Store in a cool, dry, and dark place. Long-term storage at 2–8°C is recommended for optimal stability throughout the supply chain.

Product Description

Afatinib is a potent, second-generation irreversible inhibitor of the ErbB family of tyrosine kinases. We specialise in high-purity Afatinib API, produced as a white or off-white crystalline powder. This product adheres to high-standard manufacturing protocols, designed to meet the rigorous requirements of pharmaceutical formulation research and production of non-small cell lung cancer (NSCLC) treatments.

CAS Number	439081-18-2
Molecular Formula	C₂₄H₂₅ClFN₅O₃
Molecular Weight	485.94 g/mol
Testing Method	HPLC
Appearance	White or off-white crystalline powder
Standard Pack	1 kg/aluminum foil bag; 25 kg/drum
Shelf Life	24 Months

Unique Advantages

High Purity & Consistency

Guaranteed purity of ≥98%, ensuring reliable performance and strict compliance for pharmaceutical formulations.

Stringent QC

Production and testing adhere to rigorous standards, utilizing HPLC methodology for precise quality verification of core constituents.

Industrial-Scale Supply

Available in commercial quantities (1kg & 25kg packaging), supported by a robust and reliable manufacturing process.

Mechanism of Action

Afatinib provides targeted therapeutic action through its irreversible binding mechanism:

Tyrosine Kinase Inhibition: Irreversibly binds to and blocks the signaling of Epidermal Growth Factor Receptor (EGFR) and HER2.
Tumor Suppression: Inhibits signaling pathways that are often dysregulated in cancers, thereby suppressing tumor cell proliferation and survival.
Core Active Component: Serves as the essential active pharmaceutical ingredient for high-efficacy oncology finished dosage forms.

Technical Support & FAQ

What makes Afatinib a second-generation inhibitor?

Unlike first-generation inhibitors, Afatinib forms a covalent, irreversible bond with the ErbB receptors, providing more durable inhibition of oncogenic signaling.

What are the recommended application areas?

It is primarily used for the manufacturing of finished dosage forms, such as tablets, indicated for specific types of non-small cell lung cancer (NSCLC).

How do you ensure batch-to-batch stability?

Every batch undergoes rigorous HPLC analysis and is stored under strictly controlled conditions (refrigeration at 2-8°C recommended) to maintain integrity.

⚠ Safety Warning & Declaration

This product is intended for industrial use or scientific research only. It is not for direct human consumption. Shaanxi Sunrise Pharmaceutical Co., Ltd. assumes no liability for improper handling.