TCS Industries Limited (China-sourced API supplier) supplies Amiodarone Hydrochloride — API CAS 19774-82-4 for pharmaceutical B2B procurement — COA, MSDS, and technical documentation available on request.
> Overview
| Product Name | Amiodarone Hydrochloride |
|---|---|
| Structural Formula |  |
| CAS Number | 19774-82-4 |
| Molecular Formula | C25H30ClI2NO3 |
| Molecular Weight | 681.8 g/mol |
| InChIKey | ITPDYQOUSLNIHG-UHFFFAOYSA-N |
| SMILES | Available on request where applicable |
| Appearance | White to cream-coloured crystalline powder |
| Purity / Grade | By agreed specification and batch COA |
| Storage | Store at controlled room temperature, protect from light |
Amiodarone Hydrochloride (CAS 19774-82-4) is a class III antiarrhythmic agent with the formula C₂₅H₂₉I₂NO₃·HCl (MW 681.77). It is a benzofuran derivative containing two iodine atoms per molecule, structurally related to thyroid hormone. Amiodarone is used for life-threatening ventricular arrhythmias and atrial fibrillation, and is on the WHO Model List of Essential Medicines.
TCS Industries Limited, a Hong Kong-based trading and sourcing company, supplies Amiodarone Hydrochloride API in pharmaceutical grade for global procurement programs.
> Applications
Antiarrhythmic therapy
Amiodarone blocks multiple ion channels (potassium, sodium, calcium) and has anti-adrenergic properties, making it effective against both ventricular and supraventricular arrhythmias. It is administered orally (200–400 mg/day maintenance) or intravenously (150–300 mg loading) for ventricular fibrillation, ventricular tachycardia, and refractory atrial fibrillation. Singh et al. (J Am Coll Cardiol, 2005, 45:A95–A103) reviewed the electrophysiological properties and clinical pharmacology of amiodarone across multiple arrhythmia indications.
Formulation considerations
Amiodarone HCl is poorly water-soluble (0.7 mg/mL) but freely soluble in chloroform and DMSO. IV formulations use polysorbate 80 or cyclodextrin (Nexterone) as solubilizers. Oral tablets (100 mg, 200 mg, 400 mg) are direct-compressed or wet-granulated. The iodine content (~37% by weight) requires consideration for thyroid function monitoring in patients.
> Sourcing & Supply
TCS Industries Limited supports development, qualification and commercial purchasing discussions for Amiodarone Hydrochloride with buyers in Australia, New Zealand, Canada and South Korea.
- Evaluation and commercial quantities: 500 g samples for analytical qualification; 5 kg and 25 kg drums for production. Pharmaceutical (USP/Ph.Eur.) grade available. DMF reference letters provided.
- 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 (≥98.5%), related substances by HPLC (desethylamiodarone ≤0.5%, total ≤1.0%), iodine content (37.0–38.5%), loss on drying (≤0.5%), residue on ignition, heavy metals (Pb ≤10 ppm), residual solvents, and microbial limits. White to cream-colored crystalline powder. Identity by HPLC, IR, and melting point (159–163 °C). Meets USP, Ph.Eur. (Amiodaroni hydrochloridum), and BP. COA and MSDS are standard.
> Packaging
Amiodarone HCl is a white to cream-colored crystalline powder, light-sensitive. Standard packaging includes amber glass bottles or double PE-lined aluminium foil bags in fibre drums (5 kg, 10 kg, or 25 kg). Store at controlled room temperature (15–25 °C). Protect from light. Shelf life is typically 36 months. 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
Amiodarone HCl is monographed in USP, Ph.Eur. (Amiodaroni hydrochloridum), BP, and JP. FDA-approved (Cordarone, 1985). On the WHO Model List of Essential Medicines. Multiple generic approvals worldwide. Listed in the FDA IID for oral and injectable dosage forms. DMF support available from qualified manufacturers.
> Alias Index
- INN: Amiodarone
- CAS Number: 19774-82-4 (HCl); 1951-25-3 (free base)
- Formula: C₂₅H₂₉I₂NO₃·HCl (MW 681.77)
- Brand names: Cordarone, Pacerone, Nexterone (IV)
- ATC code: C01BD01
- Iodine content: ~37% by weight
- Commercial request terms: amiodarone HCl API, Cordarone generic, antiarrhythmic API, class III antiarrhythmic, TCS Industries Limited
> FAQ
Why does Amiodarone contain iodine?
Amiodarone is a di-iodinated benzofuran derivative (~37% iodine by weight). Daily oral dosing releases ~6–9 mg of inorganic iodine. This iodine load can cause thyroid dysfunction (hypo- or hyperthyroidism) in 15–20% of patients. The iodine is structural to the molecule, not removable. Thyroid function monitoring is required during treatment.
What documents are available for Amiodarone Hydrochloride 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 Amiodarone Hydrochloride 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 half-life of Amiodarone?
Amiodarone has an extremely long elimination half-life of 40–55 days. Its active metabolite, desethylamiodarone (DEA), has a similar half-life. This means drug effects (and side effects) persist for weeks to months after discontinuation. Loading doses are required to achieve therapeutic tissue concentrations (14–28 day oral loading).
Is a DMF available for Amiodarone HCl?
Yes. TCS sources amiodarone HCl from manufacturers who maintain active Drug Master Files (DMFs) with the FDA and equivalent regulatory submissions (ASMF/CEP) with EMA. COA, stability data, and DMF reference letters are provided to support ANDA and generic marketing authorization applications.
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 Amiodarone Hydrochloride 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.
What solubilization is needed for IV formulation?
Amiodarone HCl is poorly water-soluble. Traditional IV formulations use polysorbate 80 and benzyl alcohol as excipients (Cordarone IV). Captisol (sulfobutylether-beta-cyclodextrin) is used in polysorbate-free formulations (Nexterone). IV amiodarone must be diluted in D5W (not normal saline) and administered through central venous access when possible.
Last reviewed: June 2026
> 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.