Doxorubicin HCl — API | CAS 25316-40-9

TCS Industries Limited (China-sourced API supplier) supplies Doxorubicin HCl — API CAS 25316-40-9 for pharmaceutical B2B procurement — COA, MSDS, and technical documentation available on request.

> Overview

Product Name Doxorubicin HCl
Structural Formula Doxorubicin HCl CAS 25316-40-9 structural formula
CAS Number 25316-40-9
Molecular Formula C27H30ClNO11
Molecular Weight 580.0 g/mol
InChIKey MWWSFMDVAYGXBV-RUELKSSGSA-N
SMILES Available on request where applicable
Appearance Orange-red crystalline powder or lyophilized solid
Purity / Grade By agreed specification and batch COA
Storage Store at 2–8°C, protect from light

Doxorubicin Hydrochloride (CAS 25316-40-9) is an anthracycline antibiotic antineoplastic agent with the formula C₂₇H₂₉NO₁₁·HCl (MW 579.98). Produced by Streptomyces peucetius var. caesius, doxorubicin intercalates DNA, inhibits topoisomerase II, and generates free radicals. It is active against a broad spectrum of solid tumors and hematological malignancies, and is on the WHO Model List of Essential Medicines.

TCS Industries Limited, a Hong Kong-based trading and sourcing company, supplies Doxorubicin HCl API in pharmaceutical grade for global procurement programs.

> Applications

Broad-spectrum anticancer chemotherapy

Doxorubicin is used IV at 60–75 mg/m² every 3 weeks (or lower doses in combination regimens) for breast cancer, lymphoma (CHOP, ABVD), sarcoma, ovarian cancer, multiple myeloma, and acute leukemia. It intercalates DNA, stabilizes the topoisomerase II-DNA complex (preventing religation), and generates reactive oxygen species. Gewirtz et al. (Biochem Pharmacol, 1999, 57:727–741) reviewed the multiple mechanisms of action of doxorubicin including DNA intercalation, topoisomerase II inhibition, free radical generation, and membrane interactions.

Liposomal formulations

Pegylated liposomal doxorubicin (Doxil/Caelyx) encapsulates the drug in PEG-coated liposomes, providing prolonged circulation, reduced cardiotoxicity, and enhanced tumor accumulation through the EPR effect. Non-pegylated liposomal doxorubicin (Myocet) is used for breast cancer. These formulations require different dosing schedules than conventional doxorubicin.

> Sourcing & Supply

TCS Industries Limited supports development, qualification and commercial purchasing discussions for Doxorubicin HCl with buyers in South America, Europe, the United Kingdom, Australia, New Zealand, Mexico and Canada.

  • Evaluation and commercial quantities: 5 g samples for analytical qualification; 50 g, 100 g, and 500 g for production. Fermentation-derived or semi-synthetic pharmaceutical-grade powder. Cytotoxic API — containment required. 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 (daunorubicin, 13-dihydrodoxorubicin, 7-deoxydoxorubicinone), 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 nm, 253 nm, 495 nm), and IR. Meets USP (Doxorubicin Hydrochloride) and Ph.Eur. (Doxorubicini hydrochloridum). COA and MSDS are standard.

> Packaging

Doxorubicin 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

Doxorubicin HCl is monographed in USP and Ph.Eur. FDA-approved in 1974 (Adriamycin). Pegylated liposomal doxorubicin (Doxil) approved in 1995. On the WHO Model List of Essential Medicines. Multiple generic approvals worldwide. Cytotoxic API manufacturing required. DMF support available.

> Alias Index

  • INN: Doxorubicin
  • CAS Number: 25316-40-9 (HCl); 23214-92-8 (free base)
  • Formula: C₂₇H₂₉NO₁₁·HCl (MW 579.98)
  • Brand names: Adriamycin, Doxil (liposomal), Caelyx, Myocet
  • ATC code: L01DB01
  • Related: Epirubicin (4′-epi-doxorubicin), Daunorubicin
  • Commercial request terms: doxorubicin HCl API, Adriamycin generic, anthracycline API, CHOP regimen, TCS Industries Limited

> FAQ

What is the cumulative dose limit for cardiotoxicity?

Cumulative doxorubicin dose should not exceed 450–550 mg/m² due to dose-dependent cardiomyopathy. Above this threshold, heart failure risk increases sharply. Cardiac monitoring (echocardiogram or MUGA scan) is required before and during treatment. Dexrazoxane can be co-administered as a cardioprotectant at cumulative doses above 300 mg/m² in some protocols.

What documents are available for Doxorubicin 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.

Can TCS Industries Limited support Doxorubicin HCl supply to South America?

Yes. We support B2B buyers in Argentina, Colombia, Chile, Peru, Ecuador, Uruguay, Bolivia, Brazil, Paraguay, Venezuela, Guyana and Suriname, subject to route and document review.

Do you supply Australia, New Zealand, Mexico, Canada and South Korea?

Yes. These destinations can be reviewed for project supply, import documents, packaging and logistics planning before quotation.

Why is Doxorubicin red?

Doxorubicin contains a tetracyclic aglycone chromophore (anthraquinone ring system) that absorbs visible light at ~495 nm, giving the characteristic orange-red colour. This colour makes it visually identifiable in solution and is the reason doxorubicin is sometimes called the “red devil.” The chromophore is essential for DNA intercalation activity.

What advantage does liposomal formulation provide?

Pegylated liposomal doxorubicin (Doxil) reduces cardiotoxicity (~3% heart failure vs. ~7% for conventional) and alopecia. The PEG coating provides stealth properties (reduced immune clearance), extending circulation half-life from minutes to days. Enhanced permeability and retention (EPR) effect concentrates drug in tumors. Different toxicity profile: hand-foot syndrome replaces some conventional toxicities.

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 Doxorubicin 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 doxorubicin HCl from manufacturers who maintain active DMFs with the FDA and ASMF/CEP with EMA. Fermentation-derived and semi-synthetic routes available. Cytotoxic API production requires dedicated containment facilities verified by manufacturer audit. COA, stability data, and DMF reference letters 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.

Contact the Commercial Team

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