Afatinib API CAS No: 439081-18-2
Afatinib API CAS No: 439081-18-2
Afatinib API CAS No: 439081-18-2,Afatinib API ,CAS No: 439081-18-2,Afatinib
Product Name: Afatinib API
Product Purity: ≥98%
CAS No: 439081-18-2
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Description
Afatinib Powder API (Free Base)
High-Purity Tyrosine Kinase Inhibitor Manufacturer | Oncology Raw Material CAS 439081-18-2 Supplier
Storage Guidance:
Store in a tightly closed container, protected from direct sunlight, heat, and moisture. For long-term logistics and storage stability throughout the supply chain, store under refrigeration at 2-8°C.
Store in a tightly closed container, protected from direct sunlight, heat, and moisture. For long-term logistics and storage stability throughout the supply chain, store under refrigeration at 2-8°C.
Product Description & Technical Overview
Afatinib (CAS 439081-18-2) manufactured and supplied by Shaanxi Sunrise Pharmaceutical Co., Ltd. is a highly potent, second-generation irreversible tyrosine kinase inhibitor (TKI). Unlike first-generation reversible inhibitors, Afatinib forms covalent bonds to permanently block ErbB receptor family signaling pathways, specifically targeting EGFR (ErbB1), HER2 (ErbB2), and ErbB4.
Our high-purity Afatinib raw powder is synthesized via optimized molecular pathways in state-of-the-art facilities. We strictly control the generation of isomeric impurities and structural analogs to ensure an exceptionally clean pharmaceutical ingredient. It is designed to satisfy the rigorous technical requirements of research laboratories, generic formulation developers, and international manufacturers producing finished oncological dosage forms.
| CAS Number | 439081-18-2 (Free Base) |
| IUPAC Name | (E)-N-(4-(3-chloro-4-fluorophenylamino)-7-(tetrahydrofuran-3-yloxy)quinazol-6-yl)-4-(dimethylamino)but-2-enamide |
| Molecular Formula | C24H25ClFN5O3 |
| Molecular Weight | 485.94 g/mol |
| Assay (Dried Basis) | ≥ 99.0% (HPLC Verification) |
| Appearance | White to light yellow crystalline powder |
| Single Impurity | ≤ 0.1% |
| Total Impurities | ≤ 0.5% |
| Loss on Drying | ≤ 0.5% |
| Residue on Ignition | ≤ 0.1% |
| Heavy Metals | ≤ 10 ppm |
| Standard Pack | 100g, 500g, 1 kg/bag; 25 kg/drum (customizable packaging) |
Unique Advantages of Shaanxi Sunrise Afatinib API
Ultra-Low Genotoxic Impurities
In compliance with strict ICH M7 guidelines for oncological active substances, we employ advanced multi-stage purification protocols. Our process successfully controls single mutagenic/genotoxic process impurities below 0.1%, ensuring high-level safety for formulation R&D.
Advanced Solid-State Characterization
We guarantee high batch-to-batch consistency in crystalline morphology and particle size distribution. This superior physical state optimization simplifies downstream pharmaceutical processing, enhancing solubility and dissolution performance in oral solid formulations.
Complete Technical Dossier Support
As an experienced B2B raw material manufacturer, Shaanxi Sunrise provides comprehensive structural characterization data, including HPLC, 1H-NMR, Mass Spectrometry (MS), and complete stability testing studies to streamline your regulatory filing procedures.
Mechanism of Action & Targeted Pathways
Afatinib provides therapeutic efficacy through irreversible multi-receptor blockade, addressing resistance mechanisms common in oncological mutations:
Covalent Tyrosine Kinase Blockade: Afatinib irreversibly binds to the kinase domains of EGFR (ErbB1), HER2 (ErbB2), and ErbB4 via covalent linkage. This action halts downstream autophosphorylation and suppresses key survival pathways (MAPK and AKT).
Overcoming Resistance Mutants: Due to its irreversible binding mechanism, Afatinib continues to suppress tumor cell proliferation even in the presence of specific EGFR mutations that typically cause resistance to first-generation TKIs.
Strict Quality Assurance for Oncology: High purity (≥ 99.0%) ensures that the active pharmaceutical molecule displays optimal receptor affinity without off-target toxicity triggered by synthesis byproducts.
Technical Support & FAQ
Do you offer Afatinib Dimaleate salt options as well?
Yes. While this page represents the Afatinib Free Base form (CAS 439081-18-2), Shaanxi Sunrise also manufactures and supplies Afatinib Dimaleate (CAS 850140-72-6) in commercial bulk quantities. Custom salt forms can be synthesized upon client formulation request.
What documentation is provided with international shipments?
Each batch of Afatinib API is shipped with a comprehensive Certificate of Analysis (COA), an up-to-date Material Safety Data Sheet (MSDS), and a Technical Data Sheet (TDS). High-performance liquid chromatography (HPLC) profiles are fully available for quality verification.
How are solvent residues controlled during manufacture?
Our manufacturing protocol utilizes a green chemistry pathway. Solvents used in synthesis and crystallization are carefully removed under deep vacuum drying, ensuring all residual solvents strictly comply with concentration limits set by ICH Q3C guidelines.
⚠ Safety Warning & Regulatory Declaration
This product is a highly potent active pharmaceutical ingredient (API) intended exclusively for industrial manufacturing, formulation R&D, and scientific laboratory research. It is not a finished medicine and is not for direct human or clinical veterinary use. Shaanxi Sunrise Pharmaceutical Co., Ltd. strictly sells to verified corporate buyers and research institutions only.