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Amiodarone Hydrochloride is a class III antiarrhythmic agent used for the treatment and prevention of various cardiac arrhythmias, including ventricular tachycardia, ventricular fibrillation, and atrial fibrillation. It works by prolonging the cardiac action potential and refractory period, helping to restore and maintain a normal heart rhythm.
At Bluepill Express, we manufacture and export high-quality Amiodarone Hydrochloride API under WHO-GMP, ISO 9001:2015, and cGMP-certified facilities. Our API demonstrates high assay purity (≥99%), excellent stability, and low impurity levels, making it ideal for oral tablets, injectable formulations, and combination therapies.
The API is trusted globally for its consistent quality, regulatory compliance, and suitability in cardiovascular drug formulations.
Therapeutic Applications:
- Management of ventricular tachycardia and fibrillation
- Treatment of atrial fibrillation and flutter
- Prevention of life-threatening arrhythmias
- Used in oral and intravenous formulations for acute and chronic therapy
Mechanism of Action:
Amiodarone prolongs the phase 3 repolarization of the cardiac action potential, resulting in prolongation of the refractory period. It also exhibits class I, II, and IV antiarrhythmic properties, contributing to slowed conduction, reduced automaticity, and stabilized cardiac rhythm.
Technical Specifications:
- Chemical Name: 2-Butyl-3-benzofuranyl 4-[2-(diethylamino)ethoxy]-3,5-diiodophenyl ketone hydrochloride
- Molecular Formula: C₂₅H₂₉I₂NO₃·HCl
- Molecular Weight: 648.32 g/mol
- CAS Number: 19774-82-4
- Appearance: White to off-white crystalline powder
- Assay (on dried basis): NLT 98.0% and NMT 102.0%
- Solubility: Freely soluble in ethanol; slightly soluble in water
- Storage Conditions: Store below 25°C, protected from moisture and light
Pharmacological Classification:
- Therapeutic Class: Class III Antiarrhythmic Agent
- Pharmacopoeial Standards: IP / BP / USP / EP
- Dosage Form Applications:
- Oral tablets (100 mg, 200 mg, 400 mg)
- Injectable solutions for intravenous use
- Combination cardiovascular formulations
Manufacturing & Quality Standards – Bluepill Express:
- Manufactured under WHO-GMP, ISO, and cGMP certified facilities
- High assay purity (≥99%) and controlled particle size
- Analytical testing: HPLC, NMR, FTIR for identity, purity, and stability
- DMF-ready documentation for international regulatory submissions
- Batch-to-batch consistency with long-term stability
- Compliant with ICH Q3A/B guidelines and international pharmacopoeial standards
Advantages of Bluepill Express Amiodarone Hydrochloride API:
- High purity and chemical stability for reliable formulation
- Pharmacopeial grade compliance (IP/BP/USP/EP)
- Optimized particle size for tablet and injectable preparations
- Regulatory-ready documentation including COA, MSDS, DMF
- Global supply and export support for pharmaceutical manufacturers
Packaging & Export Details:
- Packaging Sizes: 1 kg / 5 kg / 25 kg HDPE drums with double-layer LDPE liners
- Shelf Life: 3 years under recommended storage conditions
- Labeling: Compliant with international pharmacopeial and export regulations
- Export Markets: Europe, Middle East, Africa, Latin America, and Asia-Pacific
- Documentation Provided:
- Certificate of Analysis (COA)
- Material Safety Data Sheet (MSDS)
- Drug Master File (DMF)
- Stability and Validation Reports
