Ivabradine Hydrochloride is a cardiovascular active pharmaceutical ingredient belonging to the class of selective If (funny current) channel inhibitors. It is used to reduce heart rate in selected patients with chronic heart failure and stable angina. Ivabradine acts primarily on the sinoatrial node by selectively inhibiting the cardiac pacemaker If current, resulting in a reduction in heart rate without directly reducing myocardial contractility.
Ivabradine Hydrochloride is the hydrochloride salt of ivabradine and is commonly used in pharmaceutical formulations intended for cardiovascular therapy. Its mechanism provides heart-rate reduction while generally preserving myocardial contractility and atrioventricular conduction.
Ivabradine Hydrochloride is identified by CAS Number 148849-67-6. It has the molecular formula C27H37ClN2O5 and a molecular weight of 505.05 g/mol. The compound is a hydrochloride salt containing a benzazepine-related structure and a tertiary amine.
Ivabradine Hydrochloride is generally described as a white to off-white crystalline powder. It is soluble in water and polar organic solvents. The material should be handled and stored under controlled pharmaceutical conditions to maintain its quality.
Ivabradine selectively inhibits the If current in the sinoatrial node. The If current contributes to spontaneous diastolic depolarization and determines the rate of cardiac pacemaker activity. By reducing this current, Ivabradine slows the heart rate without directly affecting myocardial contractility or ventricular repolarization at therapeutic concentrations.
Ivabradine Hydrochloride is used in pharmaceutical formulations for selected patients with chronic heart failure with reduced ejection fraction and for the symptomatic treatment of stable chronic angina in appropriate patients. Its therapeutic effect is primarily related to reduction of elevated resting heart rate.
Pharmaceutical Ivabradine Hydrochloride can be characterized using validated chromatographic and spectroscopic analytical methods. HPLC may be used for assay and related-substance determination, while appropriate chromatographic and spectroscopic procedures may be used for identity testing.
Quality control of Ivabradine HCl API should include identity, assay, related substances, water content, residual solvents, elemental impurities and other applicable parameters according to the approved drug-substance specification.
Ivabradine Hydrochloride should be stored in a tightly closed container under controlled pharmaceutical storage conditions. The material should be protected from excessive heat, moisture, direct light and contamination. Specific storage requirements should follow the applicable manufacturer specification and Certificate of Analysis.
Ivabradine Hydrochloride API may be supplied for pharmaceutical manufacturing, formulation development, analytical testing and other qualified pharmaceutical applications. Product specifications, Certificate of Analysis, packaging configuration and regulatory documentation should be confirmed according to the intended application.
For Ivabradine HCl API requirements, customers can request product specifications, analytical documentation, Certificate of Analysis, packaging information and commercial details. Quality parameters should be evaluated against the applicable pharmaceutical specification before procurement.
| Parameter | Specification |
|---|---|
| Appearance | White to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |
| Loss on Drying | NMT 1.0% |
| Residue on Ignition | NMT 0.5% |
| Individual Impurity | NMT 0.5% |
| Total Impurities | NMT 1.0% |
| Water Content | NMT 1.0% |