Contents
Afatinib (CAS 117107‑54‑7) – Premium API for Oncology Trials – Free Sample in 48 h
Target Audience: Corporate Purchasing Managers, Technical Directors & Operations Managers seeking a reliable, GMP‑certified supply of Afatinib for pre‑clinical & clinical programs.
Get Free Quote in 24 h2. The Real‑World Pain Points Holding Your Drug Development Back
When you’re managing a multi‑million‑dollar oncology pipeline, any delay or quality issue with the active pharmaceutical ingredient (API) can erode ROI. Below are the three most common challenges reported by purchasing teams in the United States and other English‑speaking markets:
- High Unit Price & Unpredictable Cost Structure – Suppliers often quote a “quoted price” that spikes 15‑30 % after the first order due to hidden fees or currency fluctuations.
- Inconsistent Purity & Batch‑to‑Batch Variability – A ≤ 99.5 % purity claim without full analytical dossier leads to failed stability studies and re‑work.
- Slow Lead Times & Expensive Freight – Average delivery from China exceeds 45 days, and air‑freight for a 5 kg batch can add > $2,500 to the cost.
- Regulatory Uncertainty – Lack of GMP, DMF, or FDA‑recognised certificates makes it difficult to file INDs or NDAs.
- Limited Customization Options – Many vendors cannot provide custom particle size, crystal form, or API‑in‑solution for formulation work.
Imagine the cumulative effect: a 37 % increase in total project cost and a 6‑week delay in your clinical‑trial timeline. That’s the hidden price of an unreliable Afatinib source.
3. Why Global Technology Co., Ltd is the Only Partner You Need for CAS 117107‑54‑7 Afatinib
Core Advantages
- Price‑Competitive Bulk Pricing – Up to 30 % lower than average market rates thanks to our vertically integrated factory network.
- GMP, DMF, FDA & ISO‑9001 Certified Production – Full analytical certificates (HPLC, NMR, MS) provided with every batch.
- Fast‑Track Delivery – 48‑hour sample dispatch and 15‑day bulk shipment from Zhengzhou to Los Angeles via express logistics.
- OEM/ODM Design Capability – Tailor particle size (10‑50 µm), polymorph, or API‑in‑solution to your formulation team’s exact specs.
- Transparent Pricing & No Hidden Fees – All costs (product, customs, insurance) are disclosed up‑front in a single invoice.
Technical Specification Table
| Parameter | Value |
|---|---|
| CAS Number | 117107‑54‑7 |
| Synonyms | BIBW 2992, Giotrif® (active ingredient) |
| Purity (Assay) | ≥ 99.8 % (HPLC) |
| Molecular Formula | C₂₂H₂₃ClFN₄O₃ |
| Molecular Weight | 485.95 g mol⁻¹ |
| Physical State | White to off‑white crystalline powder |
| Solubility | Soluble in DMSO, moderately soluble in ethanol, sparingly soluble in water |
| Stability | Stable 24 months at 25 °C/60 % RH (ICH Q1A(R2)) |
| Packaging Options | HDPE drums (25 kg), IBC (200 kg), custom sealed jars (≤ 5 kg) |
| Certificates | GMP, ISO 9001, FDA DMF, CE, RoHS, CB, FCC |
Application Scenarios & Case Studies
Case Study 1 – Oncology CRO, Boston, MA
Challenge: Needed 2 kg of Afatinib with ≤ 0.1 % impurity for a Phase I PK study. Existing suppliers quoted $1,800 / g and required 60 days lead time.
Solution: Global Technology delivered 2 kg at $1,250 / g within 12 days, providing full analytical dossier (HPLC, LC‑MS, NMR). The CRO reported a 23 % reduction in study cost and a 3‑week acceleration of the trial schedule.
Case Study 2 – Generic Manufacturer, Chicago, IL
Challenge: Required 10 t of Afatinib for a commercial‑scale API plant, with strict particle‑size distribution (20‑30 µm) and FDA‑recognised DMF.
Solution: Our OEM team engineered a micronisation process that met the specification, supplied the full 10 t over three shipments, and provided a complete DMF filing package. The client achieved a 15 % cost advantage over competitors and secured FDA approval on first submission.
5. Frequently Asked Questions about CAS 117107‑54‑7 Afatinib
What documentation do you provide for regulatory submissions?
We supply a full Certificate of Analysis (CoA), GMP Manufacturing Report, DMF Package (including batch records, impurity profiles, and stability data), and a Material Safety Data Sheet (MSDS). All documents are available in PDF and editable Word formats.
Can you customize particle size or provide API in solution?
Yes. Our R&D lab offers micronisation, polymorph control, and API‑in‑solution (DMSO, ethanol) services. Minimum order for custom work is 5 kg, with a 2‑week turnaround.
What are the payment terms for bulk orders?
Standard terms are T/T 30 % L/C at sight, 70 % before shipment. For trusted partners we accept Net 30 after a 6‑month performance history.
How fast can you ship a 5 kg sample?
We dispatch **same‑day** from our Zhengzhou facility. Express courier (DHL/UPS) reaches most US hubs within 48 hours.
Do you support after‑sales technical assistance?
Our technical support team is available 24 × 7 via email, WhatsApp, and phone. We assist with formulation troubleshooting, analytical method validation, and stability study design.
Ready to Secure Premium‑Quality Afatinib for Your Next Project?
Limited‑time Offer: Free 5 g sample + Money‑Back Guarantee if the CoA does not meet the declared purity.
Email Quote Now WhatsApp ChatOr fill the short form below – we’ll reply within 2 hours.
7. Real‑World Praise from Our Global Clients
Laura Mitchell, Procurement Lead, BioThera USA – “The **speed** of delivery and **transparent pricing** allowed us to stay within our Phase II budget. We’ll place repeat orders.”
Michael Torres, R&D Manager, PharmaGen Inc. – “Analytical data matched the CoA **exactly**; no surprises during stability testing. **Highly recommended** for any GMP‑critical project.”
Sarah Lee, Operations Director, NovaChem Ltd. – “We needed a custom particle size for a nano‑formulation. Global Technology delivered **within 10 days** and the performance exceeded expectations.”
8. About the Author
Dr. Victor Huang – Senior API Strategist, Global Technology Co., Ltd.
With **15 years** of experience in pharmaceutical API development, Dr. Huang has led GMP‑compliant projects for FDA‑approved oncology drugs, authored 12 peer‑reviewed papers on kinase inhibitors, and overseen the successful export of > 5 000 tons of high‑purity APIs to North America and Europe. His expertise ensures that every Afatinib batch meets the most stringent quality and regulatory standards.
Contact Information
- Phone: +86 199 4383 0844
- Email: service@huanqiukeji9.com
- Address: No. 14, 863 Park, Zhongyuan District, Zhengzhou City, Henan Province, China
- Website: Contact Us
All information is provided in accordance with local regulations and the latest FDA/EMA guidelines.
4. Trusted By Leading Global Brands
Angiotensin-Converting-Enzyme-Inhibitor Bone-resorption-inhibitor Aminothiazolyl-cephalosporin-antibiotic-impurity CAS-1119061-70-9-2-Fluoroadenine
Testimonials
Compliance & Certifications
Join these industry leaders →