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Cardiovascular

Amiodarone

Cordarone® / Pacerone®

Amiodarone is a class III antiarrhythmic with properties of all Vaughan-Williams classes. Used for life-threatening ventricular arrhythmias.

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Product Details

Dosage FormOral Tablet / IV Injectable
Strength100 mg, 200 mg, 400 mg (oral); 50 mg/mL (IV)
StorageStore at 20–25°C. Protect from light. IV: Use within 24 hours of dilution.
CategoryCardiovascular
AvailabilityAvailable for Transfer

Indication

Life-threatening recurrent ventricular fibrillation and hemodynamically unstable ventricular tachycardia refractory to other agents.

Mechanism of Action

Multichannel blocker: primarily blocks potassium channels (class III), but also inhibits sodium channels (class I), calcium channels (class IV), and beta-adrenergic receptors (class II). Prolongs action potential and refractory period.

Technology Transfer Package

Each Burrard Pharmaceuticals technology transfer package for Amiodarone includes comprehensive documentation and support:

Master Formula

Complete formulation with manufacturing parameters, excipient specifications, and process controls.

Analytical Methods

Validated methods for assay, impurities, dissolution, and stability-indicating analysis.

CTD/eCTD Templates

Market-ready regulatory dossier templates — available through Burrard Intelligence subscription.

Stability Data

ICH-compliant stability studies (accelerated and long-term) with detailed protocols.

Manufacturing Protocols

Scale-up procedures, batch records, equipment specifications, and in-process controls.

Expert Support

Direct advisory access to formulation scientists and regulatory specialists throughout transfer.

Ready for Amiodarone Technology Transfer?

Our team can deliver the complete know-how package within 2–21 business days. Book a consultation to discuss your specific requirements.

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