Amiodarone Hydrochloride Powder Cas No.19774-82-4
Product Source: Synthetic
Product Specification: ≥98% CAS No.: 19774-82-4
Molecular Formula: C₂₅H₂₉I₂NO₃·HCl
Molecular Weight: 681.77
Testing Method: HPLC
Active Ingredient: Amiodarone (present as hydrochloride salt)
Product Characteristics: White to off-white microcrystalline powder.
Product Packaging: 1kg/bag; 25kg/drum
Storage Conditions: 2–8°C, sealed, protected from light, stored in a cool, dry, well-ventilated place.
Shelf Life: 24 months
What is Amiodarone Hydrochloride API Powder (CAS 19774-82-4)?
High-Purity Amiodarone Hydrochloride API | CAS 19774-82-4
Amiodarone Hydrochloride (CAS No. 19774-82-4) is a potent, iodinated benzofuran derivative classified as a Class III antiarrhythmic Active Pharmaceutical Ingredient (API). Manufactured under rigorous cGMP-compliant protocols at Xi'an Tihealth, our Amiodarone HCl microcrystalline powder achieves an HPLC-validated purity of ≥98.0%. Unlike conventional Class III agents, it exhibits complex electrophysiological properties by inhibiting multiple ion channels (K+, Na+, Ca2+) and antagonizing adrenergic receptors. This pharmaceutical-grade API is specifically engineered for the production of oral tablets and intravenous injectables targeting life-threatening ventricular arrhythmias and refractory atrial fibrillation, meeting the stringent monographs of USP and EP.
What are the core technical specifications?
| Parameter | Product Specification |
|---|---|
| Chemical Name | (2-butyl-1-benzofuran-3-yl)-[4-[2-(diethylamino)ethoxy]-3,5-diiodophenyl]methanone hydrochloride |
| CAS Number | 19774-82-4 |
| Molecular Formula | C25H29I2NO3⋅HCl |
| Molecular Weight | 681.77 g/mol |
| Assay (HPLC) | ≥ 98.0% |
| Appearance | White to off-white microcrystalline powder |
| Storage Conditions | 2–8°C, sealed, protected from light in a dry environment |
What is the pharmacological mechanism of action?
Amiodarone Hydrochloride facilitates cardiac rhythm stabilization through unique multi-channel regulation:
- Class III Effects (Primary): It blocks delayed rectifier potassium channels (IKr和IKs), significantly prolonging the myocardial action potential duration (APD) and effective refractory period (ERP) to terminate reentrant excitation.
- Multi-Channel Blockade: It concurrently blocks inactivated sodium channels (Class I effect) and L-type calcium channels (ICa-L, Class IV effect), which contributes to its broad-spectrum efficacy against both supraventricular and ventricular tachyarrhythmias.
- Non-Competitive Adrenergic Antagonism: It exhibits non-competitive α- and β-adrenoceptor blocking properties (Class II effect), providing hemodynamic benefits by dilating coronary arteries and reducing myocardial oxygen demand.
What are the primary industrial applications?
- Acute Arrhythmia Interventions: Foundational API for the manufacture of sterile intravenous solutions (150mg/3mL) used in hemodynamically unstable ventricular tachycardia and VF.
- Chronic Management Formulations: Utilized in oral tablet production (100mg/200mg) for preventing recurrence of atrial fibrillation and supraventricular tachycardia.
- Critical Care Research: High-specification tool compound for investigating electrophysiological interactions and thyroid hormone-related cardiac signaling.
Regulatory & Stability Notice: Intended for industrial manufacturing and R&D ONLY. Amiodarone HCl is highly photosensitive due to its iodine content. Storage under refrigerated, light-protected conditions is mandatory to prevent oxidative de-iodination and loss of potency.
Frequently Asked Questions (FAQ)
Although classified as Class III (potassium channel blocker), Amiodarone possesses a unique molecular structure that allows it to inhibit sodium channels (Class I), exert non-competitive sympathetic blockade (Class II), and inhibit calcium channels (Class IV). This broad pharmacological profile makes it exceptionally effective for refractory arrhythmias.
How do you address the low aqueous solubility of Amiodarone HCl during formulation?
Amiodarone HCl is highly lipophilic and has limited water solubility. In injectable formulations, it typically requires solubilizers such as Polysorbate 80 (Tween 80) or benzyl alcohol. Our API features optimized particle size distribution to support consistent dissolution rates in oral solid dosage forms.
Why is light protection critical for Amiodarone Hydrochloride API?
The molecule contains two iodine atoms. Exposure to ultraviolet or strong visible light can catalyze de-iodination, leading to chemical degradation and a reduction in HPLC assay. Xi'an Tihealth utilizes aluminum-sealed, light-proof packaging to maintain API integrity and a 24-month shelf life.
What is the impurity profile of Xi'an Tihealth's Amiodarone API?
Our API is synthesized using a mature pathway that minimizes process-related impurities such as 2-butylbenzofuran derivatives and inorganic iodine. We perform rigorous HPLC profiling to ensure that individual unknown impurities are ≤0.1%, fully complying with USP and EP standards.
Does Xi'an Tihealth provide documentation for regulatory drug registration?
Yes. We provide a comprehensive technical data package, including COA, MOA, Stability Data, and MSDS. Our technical team is available to assist with GMP audits and regulatory filings for pharmaceutical manufacturers globally.
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