Product Details
| Product Name: Amiodarone hydrochloride | CAS No.: 19774-82-4 |
| EC-No.: 243-293-2 | Min. Order: 1kg |
| Purity: 100.7% | Supply Ability: 1000kg |
| Release date: 2026/07/03 |
Items | Specifications | Results |
Appearance | White or almost white,fine, crystalline powder | Almost white,fine,crystalline powder |
Solubility | Very slightly soluble in water, freely soluble in methylene chloride,soluble in methanol, sparingly soluble in ethanol (96 percent). | Very slightly soluble in water, freely soluble in methylene chloride,soluble in methanol, sparingly soluble in ethanol (96 percent). |
Identification | A)IR :Conforms to Amiodarone Hydrochloride CRS | Conforms |
B)Chlorides :It gives reaction of chlorides | Conforms | |
Appearance of Solution | The solution is clear | Clear |
Not more than GY?or BY? | Less than GY? | |
PH | 3.2 to 3.8 | 3.5 |
Loss on Drying | ≤0.5% | 0.04% |
Sulphated Ash | ≤0.1% | 0.03% |
Iodides | ≤150 ppm | <150 ppm |
Impurity H | ≤0.02% | <0.02% |
Related Substances | Impurity A: ≤0.2% | ≤0.01% |
Impurity B: ≤0.2% | 0.04% | |
Impurity C: ≤0.2% | <0.01% | |
Impurity D: ≤0.2% | <0.01% | |
Impurity E: ≤0.2% | <0.01% | |
Impurity F: ≤0.2% | <0.01% | |
Impurity G: ≤0.2% | <0.01% | |
Unspecified Impurities: ≤0.10% | 0.02% | |
Total Impurities: ≤0.5% | 0.07% | |
Ethanol | ≤5000 ppm | 502 ppm |
Toluene | ≤890 ppm | <80 ppm |
Assay | 98.5%to 101.0%(dried substance) | 100.7% |
Conclusion | The product conforms to the above specifications. | |
Amiodarone hydrochloride is the hydrochloride salt form of amiodarone, a potent Class III antiarrhythmic medication. It is used primarily to treat and prevent serious, life-threatening cardiac arrhythmias (irregular heartbeats).
Primary Uses:
It is indicated for ventricular and supraventricular arrhythmias that are recurrent or resistant to other therapies, including:
Ventricular Fibrillation (VF) & Ventricular Tachycardia (VT): Especially for prevention in high-risk patients.
Atrial Fibrillation (AF) and Flutter: To maintain normal sinus rhythm (chemical cardioversion and long-term maintenance).
Other Supraventricular Tachycardias (SVTs): When standard treatments are ineffective or contraindicated.
Key Characteristics & Administration:
Mechanism: It works primarily by prolonging the cardiac action potential and refractory period (Class III effect), but also has Class I, II, and IV properties, making it a very broad-spectrum antiarrhythmic.
Administration:
Intravenous (IV): Used in hospital settings for acute, life-threatening arrhythmias.
Oral: Used for long-term maintenance therapy.
Notable Properties: It has an exceptionally long half-life (up to several weeks), requiring a loading dose regimen. It also has significant lipophilicity (fat solubility).
Important Safety Notes (Major Side Effects):
Due to its potency, amiodarone has a high risk of serious, sometimes irreversible side effects, necessitating careful patient monitoring. Major concerns include:
Pulmonary Toxicity: Interstitial pneumonitis, which can be fatal.
Thyroid Dysfunction: Can cause both hypothyroidism and hyperthyroidism.
Hepatotoxicity: Liver enzyme elevations and, rarely, hepatitis.
Cardiac Effects: Can paradoxically cause bradycardia (slow heart rate) and, rarely, worsen arrhythmias.
Other: Skin photosensitivity (blue-grey discoloration), corneal microdeposits, and neuropathic effects.
In summary, amiodarone hydrochloride is a highly effective but potentially toxic "drug of last resort" for managing severe cardiac arrhythmias, reserved for cases where the benefits outweigh its significant risks. Its use requires careful ongoing clinical and laboratory monitoring.



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- Since: 2006-04-03
- Address: Room 2015, No.2 Building Kaixin Mansion, No.107 Jinqiao Ave, Wuhan, China
info@fortunachem.com

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