Amlodipine Besilate (also known as amlodipine besylate) is a long-acting calcium channel blocker (CCB) used to treat hypertension (high blood pressure) and angina (chest pain). It belongs to the dihydropyridine class and works by inhibiting L-type calcium channels in vascular smooth muscle, leading to vasodilation and reduced blood pressure.
Amlodipine has a slow onset and long duration of action, allowing for once-daily dosing.
Indications include:
∙ Hypertension (in adults and pediatric patients)
∙ Chronic stable angina
∙ Vasospastic (Prinzmetal’s) angina
∙ Prevention of cardiovascular events (in some combination therapies)
Parent: Amlodipine / Amlodipine Besilate
Parent: Amlodipine Besilate
Parent: Amlodipine Besilate
Parent: Amlodipine Besilate
Parent: Amlodipine Besilate
Impurities in amlodipine besilate arise from multi-step chemical synthesis and degradation during formulation or storage. Due to its widespread chronic use, impurities must be strictly controlled as per ICH Q3A/B and pharmacopeial (USP/EP) standards.
Process-Related Impurities
Degradation Impurities
Elemental Impurities
Analytical Techniques for Impurity Detection
It is used to lower high blood pressure, reduce the risk of heart attack and stroke, and relieve chest pain caused by angina.
Amlodipine blocks calcium from entering vascular smooth muscle cells, leading to vasodilation, reduced peripheral resistance, and lower blood pressure.
Yes, it is generally well tolerated and safe for long-term management of hypertension and cardiovascular disease when taken as prescribed.
Amlodipine is light-sensitive and prone to oxidative degradation. It should be stored in its original container, away from light and moisture, at controlled room temperature.
