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Sotalol Hydrochloride is a non-selective beta-adrenergic blocker with Class II and Class III antiarrhythmic properties, widely used in the management of ventricular and supraventricular arrhythmias. Its dual action makes it effective in controlling heart rate and maintaining sinus rhythm, especially in patients with atrial fibrillation, ventricular tachycardia, and other rhythm disorders.
At Bluepill Express, we manufacture and supply high-purity Sotalol Hydrochloride API that meets USP, BP, and EP pharmacopoeial standards. Our API is produced under WHO-GMP, ISO 9001:2015, and cGMP-certified facilities, ensuring global quality compliance, consistent batch performance, and regulatory readiness for regulated and semi-regulated markets.
Therapeutic Uses
- Management of ventricular arrhythmias
- Treatment of atrial fibrillation and flutter
- Control of supraventricular tachycardia
- Prevention of recurrent arrhythmias post-cardiac surgery
- Used as an adjunct therapy in hypertensive patients with arrhythmias
Mechanism of Action
Sotalol Hydrochloride acts via dual pharmacological pathways:
- Beta-Adrenergic Blockade (Class II effect):
- Non-selectively blocks β1 and β2 receptors
- Decreases heart rate, cardiac output, and myocardial oxygen demand
- Potassium Channel Blockade (Class III effect):
- Prolongs cardiac action potential duration
- Increases refractory period, preventing abnormal electrical impulses
This combined action ensures effective rhythm stabilization and arrhythmia control.
Pharmacological Information
- Chemical Name: (±)-N-[4-[1-hydroxy-2-(isopropylamino)ethyl]phenyl]methanesulfonamide hydrochloride
- Molecular Formula: C12H20N2O3S·HCl
- Molecular Weight: 308.83 g/mol
- CAS Number: 959-24-0
- Therapeutic Class: Antiarrhythmic / Beta-Blocker
- ATC Code: C07AA07
Physical & Chemical Properties
| Property | Description |
|---|---|
| Appearance | White to off-white crystalline powder |
| Odor | Odorless |
| Solubility | Freely soluble in water, slightly soluble in ethanol, insoluble in chloroform |
| Melting Point | 216°C – 220°C |
| pH (1% Solution) | 4.5 – 5.5 |
| Storage Conditions | Store below 25°C, in a cool, dry, and light-protected environment |
Technical Specifications
| Parameter | Specification |
|---|---|
| Appearance | White to off-white crystalline powder |
| Identification | IR, HPLC, and UV positive |
| Assay (Purity) | ≥ 99.0% (on anhydrous basis) |
| Specific Optical Rotation | +14° to +16° |
| Loss on Drying | ≤ 0.5% |
| Residue on Ignition | ≤ 0.1% |
| Heavy Metals | ≤ 10 ppm |
| Related Substances | ≤ 0.5% (individual impurity) |
| Chloride Content | 11.2% – 11.8% |
Applications
Sotalol Hydrochloride API is primarily used in:
- Tablet formulations for oral administration
- Injectable formulations for acute arrhythmia management
- Combination therapies with antihypertensive agents
- Export to Europe, Middle East, Africa, and Latin America for cardiac drug manufacturing
Documentation Provided
- Certificate of Analysis (COA)
- Material Safety Data Sheet (MSDS)
- Technical Data Sheet (TDS)
- Method of Analysis (MOA)
- Stability Data (ICH guidelines)
- Regulatory Dossier / DMF (available on request)
Packaging & Export Details
- Available Packs: 1 kg | 5 kg | 10 kg | 25 kg HDPE / fiber drums with double poly liners
- Labeling: Product name, batch number, MFG & EXP date, net weight, storage conditions
- Shelf Life: 3 years (under recommended conditions)
- Export Regions: Asia, Africa, Middle East, Latin America, CIS countries
