Amiodarone Hydrochloride CAS 19774-82-4 — China API Manufacturer | USP/EP/ChP R&D to Production

Product Overview & China Manufacturing Landscape

Amiodarone hydrochloride is a class III antiarrhythmic agent essential for treating life-threatening ventricular arrhythmias and atrial fibrillation. With CAS number 19774-82-4 and molecular formula C₂₅H₂₉I₂NO₃·HCl, this iodinated benzofuran derivative is included on the WHO Model List of Essential Medicines. China serves as a major global manufacturing hub for amiodarone HCl API, with approximately 12 NMPA-registered production facilities. Combined Chinese annual production capacity exceeds 350 metric tons, serving both domestic consumption and export markets spanning over 60 countries. Our manufacturing base in Jiangsu Province provides direct access to specialty iodine chemical suppliers, a critical advantage given that iodine-containing intermediates represent a significant portion of raw material costs for this API.

Our Manufacturing Process & Facility Standards

Our amiodarone hydrochloride synthesis proceeds through a carefully controlled multi-step process involving iodination of the benzofuran core, etherification with the diethylaminoethoxy side chain, and final hydrochloride salt formation. The iodination stages require specialized corrosion-resistant reactor systems (Hastelloy-lined vessels) and advanced waste iodine recovery systems that achieve >95% iodine reclamation. Our quality-controlled production facility encompasses 18,000 square meters with dedicated amiodarone production suites. Final processing steps including crystallization, filtration, drying, and milling operate within ISO 14644-1 Class 7 cleanroom conditions. In-process quality controls include iodine content verification by potentiometric titration at intermediate stages, polymorphic form confirmation by XRPD, particle size distribution analysis by laser diffraction, and real-time HPLC monitoring. Our production records demonstrate batch-to-batch assay RSD of 0.8% across the last 150 commercial batches, confirming exceptional process consistency.

Quality Standards & Multi-Pharmacopeial Compliance

Our amiodarone hydrochloride API simultaneously meets USP-NF, European Pharmacopoeia (EP 11.0), Chinese Pharmacopoeia (ChP 2020), and British Pharmacopoeia (BP) requirements. Typical assay values are 99.2-100.5% on a dried basis. Critical quality attributes include related substances control (Impurity A ≤0.15%, total impurities ≤0.5%), iodine content (within 33.0-34.5% theoretical range), residual solvents (ICH Q3C Class 2 solvents well below limits), loss on drying (≤0.5%), and heavy metals (≤20 ppm). Polymorphic form is confirmed as Form I by X-ray powder diffraction with each batch. Particle size distribution is controlled to D90 ≤50 μm to ensure appropriate dissolution characteristics for tablet formulations. Every shipment receives a detailed COA covering all pharmacopeial tests plus extended characterization data. Accelerated and long-term stability data per ICH Q1A are available upon request.

Regulatory Documentation & Registration Support

Our amiodarone hydrochloride regulatory package is one of the most complete in our portfolio. We hold an active US FDA Type II Drug Master File with current annual reports, a European CEP granted by EDQM, NMPA drug registration certificate, and quality certificates from both Chinese provincial authorities and successful FDA pre-approval inspection history. Our manufacturing site carries active FDA establishment registration. For markets requiring additional documentation, we provide WHO prequalification supporting data, Health Canada DMF, and ANVISA-formatted technical dossiers. Our regulatory team actively supports customer registration efforts by providing CTD Module 3.2.S documentation, coordinating inspector visit logistics, and preparing technical responses to regulatory authority questions. We have a track record of zero critical findings across 8 international regulatory inspections in the past 5 years.

Packaging, Storage & Global Logistics

Amiodarone hydrochloride API is packaged in double-layer polyethylene bags within fiber drums or aluminum drums, depending on customer preference and regulatory market requirements. Standard packaging sizes include 1 kg, 5 kg, and 25 kg units. All packaging is light-protective given the photosensitivity of amiodarone. Storage requirements specify temperatures below 25°C in a dry environment protected from light, with a validated shelf life of 48 months. We arrange shipments through our established logistics partnerships covering sea freight (25-35 days to European ports, 18-22 days to Southeast Asian ports), rail freight via China-Europe express (14-18 days), and air freight (3-7 days globally). Each shipment includes complete documentation: commercial invoice, packing list, COA, material safety data sheet, and any market-specific certificates required by the customer.

Competitive Pricing & Supply Reliability

Our integrated manufacturing approach — from iodine-containing intermediates through finished API — provides a significant cost structure advantage. Direct manufacturer-direct supply eliminates multiple layers of distribution markup, delivering pricing that typically undercuts European and Indian sources by 35-50% for equivalent pharmacopeial quality. Minimum order quantity is 25 kg for new customer evaluation, with commercial orders generally starting at 100 kg. We offer flexible pricing models including spot pricing, quarterly fixed pricing, and annual contract pricing with volume commitments. Our current production capacity supports monthly output of 8-10 metric tons of amiodarone HCl API, with dedicated raw material inventory maintained for 4+ months of continuous production. Long-term supply agreements with guaranteed allocation are available for customers requiring supply security for this essential medicine.

Product Specifications