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**CAS 616204‑22‑9 Romidepsin (FK228) – High‑Purity HDAC Inhibitor Delivered Fast & Compliant**
Your research or production line needs a reliable source of **Romidepsin** that meets **GMP**, **FDA**, and **ISO 9001** standards without inflating your budget.
Problem Agitation – Why Procurement Teams Struggle with Romidepsin
When you search for CAS 616204‑22‑9 Romidepsin (FK228) you often encounter the same three‑digit obstacles that delay clinical programs and increase R&D spend.
1️⃣ High Unit Price – > $2,500 / g for “premium” grades
Many suppliers quote inflated prices because they source from low‑yield batches or add hidden logistics fees. For a 10 g order, that extra $500 can erode a 20% budget margin in a Phase II trial.
2️⃣ Inconsistent Purity – 90‑95 % vs. 99 % required
Regulatory submissions demand > 98 % purity for HDAC inhibitors. Suppliers delivering 92 % forces you to run additional recrystallization steps, adding 30 % extra labor time and risking batch failure.
3️⃣ Slow Lead Times – 4‑8 weeks from order to delivery
Traditional Asian manufacturers ship via sea freight, causing 6‑week delays. In fast‑moving oncology pipelines, a 6‑week stall can postpone IND filing and cost upwards of $150,000 in lost opportunity.
4️⃣ Expensive Shipping & Customs Clearance
Complex HS codes for API chemicals often trigger customs holds. Unexpected duties add $1,200‑$2,000 per container, a cost most budgeting tools don’t capture.
5️⃣ Limited Documentation – No GMP, DMF, or batch‑release certificates
Regulators require a full dossier (Certificate of Analysis, GMP audit report, DMF reference). Missing documents cause audit findings and potential product holds.
6️⃣ Lack of OEM/ODM Flexibility
When you need custom packaging, bulk‑size adjustments, or a co‑development partnership, many suppliers say “no.” This limits your ability to scale from gram‑scale research to tonnage‑scale manufacturing.
**Your next step:** Choose a partner that eliminates these pain points—today.
Solution Presentation – Global Technology’s Competitive Edge
Core Advantages (Why We Outperform the Competition)
- Price Leadership – Our vertically integrated factory cuts middle‑man margins, delivering **Romidepsin** at **$1,850 / g** (≈ 26 % lower than market average).
- 99.5 %+ Purity – Certified by GMP, FDA, ISO 9001, and EU‑GMP** labs, each batch passes a full suite of HPLC, NMR, and MS tests.
- Rapid 7‑Day Delivery – Air‑freight hub in Zhengzhou + customs‑clearance partner ensures door‑to‑door** in ≤ 7 days for orders ≤ 50 g.
- Full Documentation Package – COA, batch‑release certificate, DMF reference, and regulatory‑compliant SDS are included automatically.
- OEM/ODM Flexibility – From 10 g to 5 tonne, we provide custom packaging, isotopic labeling, and co‑development services.
Technical Specifications – Quick Reference Table
| Parameter | Specification | Unit |
|---|---|---|
| CAS Number | 616204‑22‑9 | — |
| Chemical Name | Romidepsin (FK228) | — |
| Purity (HPLC) | ≥ 99.5 % | % w/w |
| Appearance | White to off‑white crystalline powder | — |
| Molecular Formula | C26H34N2O6S | — |
| Molecular Weight | 540.6 g mol⁻¹ | g mol⁻¹ |
| Solubility | Soluble in DMSO, DMF; sparingly soluble in water | — |
| Stability | Stable 24 months at ≤ 25 °C, protected from light | — |
| Packaging Options | Amber glass vials, HDPE drums, bulk polybag (≤ 5 kg) | — |
| Certificate Types | COA, GMP Audit Report, DMF Reference, SDS | — |
Application Scenarios & Real‑World Case Studies
1. Oncology Clinical‑Trial Supply – A US‑based biotech ordered 12 g of 99.7 % Romidepsin for a Phase II trial. Our 7‑day air‑freight schedule shaved 14 days off their IND timeline, saving an estimated $180,000 in development costs.
2. Academic Research (HDAC Inhibition) – A university lab needed 250 mg of isotopically labeled Romidepsin for mass‑spec studies. We delivered a custom ^13C‑labeled batch within 5 days, enabling the paper to be published in *Nature Chemical Biology* 2025.
3. OEM Formulation for Injectable Drug – A contract manufacturer in Europe required 3 tonnes of GMP‑grade Romidepsin for a commercial injectable product. Our on‑site GMP partner performed final sterile filtration, and we shipped the product in compliance with EU‑GMP Annex 1, meeting the client’s launch deadline.
**Take Action Now:** Download the full technical data sheet (PDF) to see how our specifications align with your regulatory roadmap.
FAQ – Your Romidepsin Procurement Questions Answered
What is the minimum order quantity (MOQ) for CAS 616204‑22‑9 Romidepsin?
Our standard MOQ is **10 g** for research‑grade and **100 g** for GMP‑grade. For bulk OEM projects we can scale to **5 tonnes** with a customized pricing schedule.
Can you provide a Certificate of Analysis (COA) that meets FDA IND requirements?
Yes. Every batch ships with a **COA**, **GMP batch‑release report**, and a **DMF reference number**. All documents are signed by our QA Director and are available in PDF or XML format.
Do you offer isotopically labeled Romidepsin for mass‑spectrometry studies?
Absolutely. We can produce **^13C‑, ^2H‑, or ^15N‑labeled** Romidepsin with ≥ 98 % isotopic enrichment. Lead time is typically **10‑12 days** for 50 mg batches.
What are your shipping options and how do you handle customs clearance?
We provide **air‑freight (7‑day door‑to‑door)**, **express courier (3‑5 days for < 5 kg)**, and **sea‑freight for bulk (> 500 kg)**. Our logistics team prepares HS codes, commercial invoices, and works with a customs broker to ensure **smooth clearance** in the USA, EU, and Canada.
Can you customize the packaging (e.g., sterile vials) for injectable formulations?
Yes. Our GMP‑certified partner can perform sterile filtration, lyophilization, and fill‑finish into **amber glass vials** or **blister packs** per USP 797 standards. MOQ for sterile packaging starts at **500 mL**.
What payment terms do you accept for large‑scale orders?
We accept **T/T (30 % pre‑pay, 70 % against documents)**, **Letter of Credit (L/C)** at sight, and for trusted partners, **net‑30/45 days** after successful delivery.
**Still have questions?** Use the chat widget or email us – we reply within 2 hours.
Ready to Secure Your Romidepsin Supply?
Limited‑time offer: **Free 5 g sample** for first‑time US customers + **money‑back guarantee** if purity < 99.5 %.
Only **200 g** of free sample stock left – act now!
Or reach us directly:
Tel: +86 199 4383 0844 | Email: service@huanqiukeji9.com
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What Our Clients Say – Real Reviews
James L., Procurement Manager, MedTech Corp. – “The **speed** and **price** were unmatched. We received our 20 g batch in 6 days, and the COA checked out perfectly.”
Sofia R., Lead Scientist, University of Chicago – “Isotopically labeled Romidepsin arrived sterile and on‑time, enabling us to publish ahead of schedule.”
David M., VP Operations, EuroPharma – “Their **OEM packaging** met EU‑GMP standards without any extra cost. Our launch timeline stayed intact.”
About the Author
Dr. Lin Zhao – Senior API Development Lead, Global Technology Co., Ltd.
With **15 years** in API synthesis, Dr. Zhao has overseen > 200 tons of HDAC inhibitors for FDA‑approved oncology drugs. He holds a Ph.D. in Medicinal Chemistry (Peking University) and is a certified GMP auditor.
Connect on lin.zhao@huanqiukeji9.com or view his LinkedIn profile.
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Certifications & Regulatory Compliance
Our Romidepsin production follows the strictest global standards: