Amiodarone Hydrochloride

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Cat Number

API0231547

CAS Number

19774-82-4

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Product Detail Description Scientific Support Customer Q&A

CAS Number

19774-82-4

EINECS

243-293-2

Storage

Store at room temperature

Synonyms

Amiodarone HCL; Nexterone; Amiodar; Ritmocardyl; Pacerone; Miodaron; Ortacrone; SKF 33134-A; NSC-85442

Molecular Formula

C25H30ClI2NO3

Molecular Weight

681.8

Smiles

CCCCC1=C(C2=CC=CC=C2O1)C(=O)C3=CC(=C(C(=C3)I)OCCN(CC)CC)I.Cl

Appearance

White to off-white powder

Melting Point

156℃

Boiling Point

635.1℃

Relative Density

1.58

General Description

Amiodarone hydrochloride is a potent, class III antiarrhythmic agent with complex electrophysiological properties that include activity across all Vaughan-Williams classes. It is available in oral and intravenous formulations and is characterized by an exceptionally long half-life of 40 to 60 days. The drug is highly lipophilic, accumulating extensively in adipose tissue and myocardium, which contributes to its delayed onset and prolonged duration of action.

Mechanism of Action

Amiodarone primarily prolongs repolarization by blocking potassium channels, specifically the rapid component of the delayed rectifier potassium current (IKr), thereby extending the cardiac action potential duration and refractory period. It also non-competitively blocks sodium and calcium channels and exhibits non-selective beta-adrenergic antagonism. This multi-channel blockade suppresses automaticity, slows conduction, and prevents reentrant arrhythmias without significant negative inotropy.

Application

It is indicated for the treatment of recurrent ventricular fibrillation and hemodynamically unstable ventricular tachycardia, as well as for the maintenance of sinus rhythm in patients with atrial fibrillation or flutter. Despite its efficacy, use is often limited by a distinctive adverse effect profile including pulmonary fibrosis, thyroid dysfunction, corneal microdeposits, blue-gray skin discoloration, and hepatotoxicity. Regular monitoring of thyroid, liver, and pulmonary function is mandatory during chronic therapy.

Using in vitro canine left ventricular wedge preparations and in vivo pig resuscitation models, this study examined how amiodarone interacts with therapeutic hypothermia (32°C) during cardiac arrest. In vitro, hypothermia alone prolonged action potential duration, but adding amiodarone increased dispersion of repolarization and slowed conduction velocity during ischemia—effects not seen at normothermia. However, conduction block occurred only at 36°C, not at 32°C. In vivo, amiodarone suppressed ventricular fibrillation rearrest but did not worsen dispersion or conduction velocity. The authors conclude that while amiodarone abolishes some beneficial effects of hypothermia on ischemia‑induced electrophysiological parameters, it does not increase susceptibility to malignant arrhythmias during resuscitation.

Fig. 1 Effect of amiodarone on transmural conduction velocity. (Piktel JS, et al., 2021)

References

Piktel JS, et al. Effect of Amiodarone and Hypothermia on Arrhythmia Substrates During Resuscitation. J Am Heart Assoc. 2021; 10(10):e016676.

Does Amiodarone Hydrochloride require protection from light during storage?

Yes, it is highly photosensitive. Exposure to light, especially UV, causes rapid discoloration and degradation. Store in light-resistant, opaque containers, preferably amber glass.

What is the recommended storage temperature for Amiodarone Hydrochloride?

Store at controlled room temperature (15-25°C). Avoid excessive heat above 30°C, as it can accelerate decomposition and cause melting or softening of the material.

Is Amiodarone Hydrochloride stable in intravenous solution formulations?

Reconstituted solutions are sensitive to light and should be used within 24 hours.

How is the iodine content and related impurities monitored during stability?

We use ion chromatography to monitor free iodide and HPLC to track organic iodine-related impurities, ensuring compliance with pharmacopoeial limits.