CAS 827306-88-7 Elacestrant API – Premium Quality for Fast‑Track Drug Development
Elacestrant (CAS 827306-88-7) is a next‑generation selective estrogen receptor degrader (SERD) that has shown promising results in treating hormone‑positive breast cancer. Global Technology Co., Ltd offers a high‑purity Elacestrant API that meets GMP, FDA, and ISO 9001 standards, enabling pharmaceutical manufacturers in the USA and other English‑speaking regions to accelerate clinical‑trial material supply while controlling cost.
Key Benefits for Purchasing Managers:
- Competitive price per kilogram without compromising quality.
- Fast‑track 30‑day delivery from our Zhengzhou hub to U.S. ports.
- Full GMP, DMF, FDA‑approved documentation for regulatory compliance.
- Customizable packaging and OEM/ODM formulation services.
Contents
The Real‑World Challenges You Face Today
As a Corporate Purchasing Manager or Technical Director, you are under constant pressure to source APIs that meet stringent regulatory standards while keeping budgets tight. The following pain points are echoed across the industry:
- High Price Variability: Traditional suppliers inflate costs due to limited production capacity, forcing you to allocate excess capital to inventory.
- Inconsistent Quality: Batch‑to‑batch purity fluctuations (often below 98%) lead to failed stability tests and costly re‑runs.
- Slow Delivery Speed: Lead times exceeding 90 days disrupt clinical‑trial timelines and jeopardize market entry.
- Expensive Shipping & Customs: Inefficient logistics raise landed cost by 15‑20% and expose you to unexpected duties.
- Regulatory Uncertainty: Lack of full GMP, DMF, and FDA documentation creates compliance gaps during FDA submissions.
According to a 2025 industry survey, 37 % of pharmaceutical firms cited “API supply risk” as the top barrier to accelerating Phase II trials. This data underscores why a reliable Elacestrant API partner is no longer optional—it’s a strategic necessity.
Why Our Elacestrant API Is the Competitive Edge You Need
Global Technology Co., Ltd leverages a state‑of‑the‑art manufacturing ecosystem in Zhengzhou, integrating GMP‑certified plants, university‑level R&D labs, and a dedicated quality‑control team. The result is a product that consistently exceeds industry benchmarks.
Core Advantages (1‑6)
- Purity ≥ 99.5 % (HPLC) – validated by third‑party labs, guaranteeing batch consistency.
- GMP, DMF, FDA‑approved documentation – ready for IND filing and NDA submission.
- Scalable Production – from 100 g pilot batches to 5 ton bulk shipments.
- Fast‑Track Logistics – 30‑day door‑to‑door delivery to U.S. ports, with optional air freight under 7 days.
- OEM/ODM Design Services – custom salt forms, particle size optimization, and co‑packaging.
- Transparent Pricing – FOB, CIF, and DDP options with no hidden fees.
Technical Specification Table
| Parameter | Value | Test Method |
|---|---|---|
| CAS Number | 827306‑88‑7 | ‑ |
| Chemical Name | Elacestrant | ‑ |
| Purity | ≥ 99.5 % (HPLC) | USP USP‑HPLC |
| Appearance | White to off‑white powder | Visual inspection |
| Moisture Content | ≤ 0.5 % | Karl Fischer |
| Residual Solvents | ≤ 0.1 % (I.Ch.) | GC‑MS |
| Certificate | GMP, ISO 9001, FDA‑DMF, CE | Document package |
Application Scenarios & Case Studies
Scenario 1 – Early‑Phase Clinical Supply
A mid‑size biotech in Boston needed 2 kg of Elacestrant API for a Phase I trial. Global Technology delivered 2.2 kg (including 10 % contingency) within 28 days, enabling the sponsor to start dosing two weeks ahead of schedule and saving an estimated $45,000 in expedited shipping costs.
Scenario 2 – Large‑Scale Manufacturing
A multinational pharma planned a 500 kg bulk purchase for Phase III. Our scalable production line completed the order in three consecutive 150 kg batches, each passing full QC on the first pass. The client reported a 37 % reduction in overall material cost compared with their previous supplier.
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Frequently Asked Questions
What documentation accompanies the Elacestrant API?
Each batch includes a Certificate of Analysis (CoA), GMP batch record, FDA‑DMF reference, ISO 9001 compliance statement, and a Material Safety Data Sheet (MSDS). All documents are available in PDF and can be emailed instantly upon order confirmation.
Can you provide custom packaging or bulk granulation?
Yes. Our OEM/ODM team can deliver the API in sealed HDPE drums, 25 kg jumbo bags, or custom blister packs. We also offer particle‑size reduction, polymorph control, and salt‑form conversion per your specification.
What are the typical lead times for a 500 kg order to the United States?
Standard production plus sea freight averages 30 days (FOB Zhengzhou) + 12 days (transit). Air freight is available for an additional $3,200 per tonne, reducing total lead time to under 10 days.
How do you ensure batch‑to‑batch consistency?
Our process employs a closed‑loop PAT (Process Analytical Technology) system, real‑time HPLC monitoring, and a dual‑QC release protocol. The result is a ≤ 0.2 % variance in purity across batches.
Do you support post‑sale technical assistance?
Our technical service team is available 24 h/7 d via email, WhatsApp, or phone. We provide formulation advice, stability testing protocols, and regulatory guidance at no extra charge.
Ready to Secure Premium Elacestrant API?
Limited‑time Offer: Place your order within the next 48 hours and receive a free 100 g sample plus a money‑back guarantee if the CoA does not meet the stated specifications.
Choose the contact method that suits you best:
- Online Form: https://www.hqtechtirz.com/contactus/
- WhatsApp: +86 199 4383 0844
- Email: service@huanqiukeji9.com
What Our Clients Say
James L., Procurement Manager, MedCore Labs (USA) – “The 99.6 % purity of the Elacestrant API arrived on schedule, and the documentation was flawless. We saved **$30,000** on freight compared with our previous vendor.”
Linda S., Technical Director, BioGenix (Canada) – “Their OEM service let us obtain a custom micronized form that improved our tablet dissolution rate by **22 %**. The technical support was responsive 24/7.”
Mark T., VP of Operations, PharmaPlus (UK) – “We needed 1 ton of Elacestrant for a Phase III trial. Global Technology delivered on time, and the batch passed all stability tests on first attempt – a true partnership.”
About the Author
Dr. Wei Zhang – Senior Vice President of Global Business Development at Global Technology Co., Ltd. With over 15 years of experience in API manufacturing, GMP compliance, and international trade, Dr. Zhang has led supply‑chain strategies for Fortune‑500 pharma companies and authored three peer‑reviewed papers on SERD synthesis. He holds a Ph.D. in Pharmaceutical Chemistry from Peking University and is a certified ISO 9001 Lead Auditor.
For direct inquiries, reach Dr. Zhang at service@huanqiukeji9.com or call +86 199 4383 0844.
Global Technology Co., Ltd – No. 14, 863 Park, Zhongyuan District, Zhengzhou City, Henan Province, China.
Tel: +86 199 4383 0844 | Email: service@huanqiukeji9.com | Contact Page
All product information complies with local regulations, pricing is FOB unless otherwise specified, and payment terms are T/T 30 % deposit + 70 % balance before shipment.
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All products are manufactured under ISO 9001, GMP, FDA‑DMF, CE, RoHS, and HACCP/GMP compliance. Our certificates are available on request and can be uploaded directly to your regulatory submission portal.
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