TCS Industries Limited (China-sourced API supplier) supplies Epirubicin HCl — API CAS 56390-09-1 for pharmaceutical B2B procurement — COA, MSDS, and technical documentation available on request.
> Overview
| Product Name | Epirubicin HCl |
|---|---|
| Structural Formula |  |
| CAS Number | 56390-09-1 |
| Molecular Formula | C27H30ClNO11 |
| Molecular Weight | 580.0 g/mol |
| InChIKey | MWWSFMDVAYGXBV-FGBSZODSSA-N |
| SMILES | Available on request where applicable |
| Appearance | Orange-red powder |
| Purity / Grade | By agreed specification and batch COA |
| Storage | 2–8°C, protect from light |
Epirubicin Hydrochloride (CAS 56390-09-1) is a 4′-epimer of doxorubicin, an anthracycline antineoplastic agent with the formula C₂₇H₂₉NO₁₁·HCl (MW 579.98). Epirubicin has the same molecular weight as doxorubicin but with an axial-to-equatorial change in the 4′-hydroxyl group of the sugar moiety. This stereochemical difference results in faster elimination and reduced cardiotoxicity compared to doxorubicin.
TCS Industries Limited, a Hong Kong-based trading and sourcing company, supplies Epirubicin HCl API in pharmaceutical grade for global procurement programs.
> Applications
Breast cancer and solid tumor chemotherapy
Epirubicin IV 75–120 mg/m² every 3 weeks is used in combination regimens for breast cancer (FEC: fluorouracil, epirubicin, cyclophosphamide), gastric cancer (ECF), and other solid tumors. It is preferred over doxorubicin in breast cancer protocols due to its better cardiac safety profile at equivalent or higher doses. Piccart et al. (J Clin Oncol, 2001, 19:3103–3110) compared epirubicin-based and doxorubicin-based adjuvant regimens for breast cancer and demonstrated equivalent efficacy with superior cardiac tolerability for epirubicin at higher cumulative doses.
Intravesical therapy
Epirubicin 50–80 mg intravesically is used for non-muscle-invasive bladder cancer (NMIBC) as an alternative to mitomycin C. Instillation after TURBT reduces recurrence risk.
> Sourcing & Supply
TCS Industries Limited supports development, qualification and commercial purchasing discussions for Epirubicin HCl with buyers in Australia, New Zealand, Canada and South Korea.
- Evaluation and commercial quantities: 5 g samples for analytical qualification; 50 g and 500 g for production. Fermentation-derived or semi-synthetic pharmaceutical-grade powder. Cytotoxic API. DMF reference letters available.
- Pallet quantities and production campaigns: repeat supply is coordinated against packaging, lead time, annual demand and destination-market import requirements.
> Quality & Documentation
Key specification parameters include assay (≥98.0%), related substances (doxorubicin ≤0.5%, 13-dihydroepirubicin), loss on drying, residual solvents, heavy metals, and microbial limits. Orange-red crystalline powder. Soluble in water and methanol. Handle as cytotoxic material. Light-sensitive. Identity by HPLC, UV-Vis (λmax 233, 253, 495 nm), and IR. Meets USP (Epirubicin Hydrochloride) and Ph.Eur. (Epirubicini hydrochloridum). COA and MSDS are standard.
> Packaging
Epirubicin HCl is an orange-red crystalline powder, cytotoxic and light-sensitive. Standard packaging includes amber glass vials or double-sealed foil bags under nitrogen (5 g, 10 g, 50 g, or 100 g). Store at 2–8 °C. Protect from light. Cytotoxic substance labeling applies. Shelf life is typically 36 months at 2–8 °C. Labels and documents are checked before dispatch.
> Pricing & MOQ
Pricing is quoted by specification, packaging and destination. Common commercial discussions use 25 kg bag/drum formats, pallet quantities and production-campaign planning; smaller samples may be reviewed for qualified formulation teams.
> Regulatory & Compounding Context
Epirubicin HCl is monographed in USP and Ph.Eur. FDA-approved in 1999 (Ellence) for breast cancer. EMA-authorized. On the WHO Model List of Essential Medicines. Multiple generic approvals. Cytotoxic API manufacturing required. DMF support available.
> Alias Index
- INN: Epirubicin
- CAS Number: 56390-09-1 (HCl)
- Formula: C₂₇H₂₉NO₁₁·HCl (MW 579.98)
- Brand name: Ellence, Pharmorubicin
- ATC code: L01DB03
- Related: Doxorubicin (4′-epimer parent), Daunorubicin
- Commercial request terms: epirubicin HCl API, Ellence generic, anthracycline API, FEC regimen, TCS Industries Limited
> FAQ
How does Epirubicin differ from Doxorubicin?
Epirubicin is the 4′-epimer — the C-4′ hydroxyl is equatorial instead of axial. This increases glucuronidation rate, resulting in faster elimination (half-life ~33 hours vs. ~48 hours for doxorubicin). The cumulative cardiotoxicity threshold is higher (900 mg/m² vs. 450–550 mg/m² for doxorubicin), allowing higher total doses.
What documents are available for Epirubicin HCl orders?
COA and MSDS are standard for commercial discussions. COO, packing list, invoice and other import-support documents can be arranged according to order scope.
Do you supply Epirubicin HCl to Australia and Canada?
Yes. We support B2B buyers in Australia, New Zealand, Canada and South Korea, subject to route and document review.
Do you supply New Zealand and South Korea?
Yes. We review Australia, New Zealand, Canada and South Korea for project supply, import documents, packaging and logistics planning before quotation.
What is the FEC regimen?
FEC: 5-Fluorouracil 500 mg/m² + Epirubicin 100 mg/m² + Cyclophosphamide 500 mg/m² every 3 weeks for 6 cycles. This is a standard adjuvant chemotherapy regimen for early breast cancer. Dose-dense (every 2 weeks with G-CSF support) schedules are also used. FEC may be followed by taxane (docetaxel or paclitaxel) in sequential regimens.
Is the cardiotoxicity threshold really higher?
Yes. Clinical data show that the risk of congestive heart failure rises sharply above 900 mg/m² cumulative epirubicin versus 450–550 mg/m² for doxorubicin. This allows higher total doses and more treatment cycles. However, cardiac monitoring (ECHO/MUGA) is still required during treatment.
Can you arrange samples before commercial purchasing?
Samples or evaluation quantities may be reviewed for qualified buyers after target specification, application and destination-market requirements are clarified.
How is Epirubicin HCl packaged for export?
Packaging is confirmed by quantity and material properties. Typical options include foil bags, HDPE containers, fibre drums, 25 kg bags or palletized export packaging.
Can buyer-defined specifications be reviewed?
Yes. Send the specification, methods, impurity limits and required documents. TCS can review feasibility before confirming quotation and lead time.
What payment terms are normally used?
Standard payment is 100% T/T before dispatch unless a different arrangement has been approved for an established commercial account.
What lead time should buyers expect?
Lead time depends on stock, batch size, document scope and destination. Available stock can move faster; made-to-order or pallet programs require longer planning.
Is a DMF available?
Yes. TCS sources epirubicin HCl from manufacturers who maintain active DMFs with the FDA and ASMF/CEP with EMA. Cytotoxic API production requires dedicated containment. COA, stability data, and DMF reference letters are provided.
Last reviewed: June 2026
Evaluation and research orders (≤10 kg) are shipped with COA, MSDS, and certificate of origin. Bulk commercial orders (>10 kg) qualify for volume pricing with a full technical documentation package available on request.
> Request a Quote
If your team already has a target application, estimated quantity, destination market, or documentation requirements, send those details so the commercial response can be prepared more efficiently.